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The global bone & joint health supplements market is estimated to be valued at USD 11.7 billion in 2022. It is projected to reach USD 17.6 billion…

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during the forecast period. Rising incomes have prompted households to increase their budgets and spend more on health and nutrition in addition to necessities such as food. Nutrition bars, in addition to protein supplements, are gaining popularity, particularly in urban areas.

New York, June 27, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Bone & Joint Health Supplements Market by Type, Distribution Channels, Form, Target Consumers and Region - Global Forecast to 2027" - https://www.reportlinker.com/p06288924/?utm_source=GNW According to experts, food/sport supplements are becoming more popular, particularly vegetarians, increasingly feel the need to meet their protein requirements in order to stay healthy.

North America is projected to witness the growth of 7.9% during the forecast period.The bone & joint health supplements market in North America is growing at a CAGR of 7.9% due to the rising awareness related to health trends, the popularity of bone & joint health supplements is witnessing a surge in the region. Insufficient exercise, low vitamin D levels, and inadequate calcium are becoming more widely recognized in modern life. Vitamin D deficiency affects around 70% of children in the United States. Adults have been shown to have a similar level of vitamin D deficiency. Vitamin D is found in oily fish such as salmon and swordfish, as well as smaller amounts in tuna and other seafood. Vitamin D is difficult to obtain in sufficient amounts through diet alone. Along with that, insufficient exercise, low vitamin D levels, and inadequate calcium are becoming more widely recognized in modern life. Vitamin D deficiency affects around 70% of children in the United States. Adults have been shown to have a similar level of vitamin D deficiency. More than three-quarters of Americans take nutritional supplements each year, a clear trend that demonstrates the importance of supplementation in their overall health and wellness routines.

The elderly people segment dominated the bone & joint health supplements market by target consumers. It is estimated at USD 5,410.2 million in 2022.It is projected that the elderly people segment by target consumers will witness the highest growth during the forecast period, owing to the increasing aging populations associated with it.Aging gracefully, adopting a healthy lifestyle, staying active are some of the key goals of the majority of the aging population.

As one ages, it becomes a challenge to get the right amount of vitamins and minerals for the body.Fortunately, consumption of bone and joint health supplement fills the gap for such deficiencies.

Many older adults in the United States take one or more bone and joint supplements either as a pill or drink.Popular supplements include some nutrients that are under consumed among older adults, including calcium and vitamins D and calcium.

Among all other vitamins, vitamin D has been consumed at a higher rate. In older adults, vitamin D helps to support skeletal health by building and protecting bones.

Other distributions channels is fastest growing segment. It is projected to grow at 9.2% during forecast period.Others distribution channels includes speciality food stores, convenience stores, direct-to-consumer, fitness institutes, and E-commerce.Many companies and retailers offer online services to facilitate consumers in terms of placing an order as well as delivering the same.

Several one-stop shops are present on the web in easing the purchasing process of the consumers.These online retails also offer a variety of options for a particular bone and joint health supplement product at discounted rates than traditional retail prices to attract more customers.

Since the last decade, the increased frequency of online shopping had created opportunities to enhance the product sales of leading online players as well as for regional domestic e-retailers, such as Wheafree in India and Healthy Supplies Ltd. in the UK.

Break-up of Primaries: By Value chain side: Supply side-59%, Demand side-41% By Designation: CXOs- 31%, Managers- 24%, Executives 45% By Region: Europe - 29%, Asia Pacific 32%, North America - 24%, RoW 15%

Leading players profiled in this report: Bayer AG(Germany) Procter & Gamble (US) Amway (US) Basf SE (Germany) Archer Daniels Midland (US) Reckitt Benckiser (UK) Pfizer (US) Vita Life Sciences Ltd (Australia) Arazo Nutrition (US) Natures Sunshine Products, Inc (US) (France) Glanbia Plc (Ireland) Vitawin(India) Nutramax Laboratories Consumer Care, Inc(US) Simply Supplements(UK) Love Life Supplements(UK) Now Foods(US) Bellavita Healthcare Pvt Ltd(India) Vitaco(New Zealand) Nutravita(UK) Life Extension(US) Pure Encapsulations, LLC (US) Herbs Nutriproducts Pvt. Ltd. (India) Millennium Herbal Care (India)

Research Coverage:The report segments the bone & joint health supplements market on the basis of type, distribution channel, form, target consumer and region. In terms of insights, this report has focused on various levels of analysesthe competitive landscape, end-use analysis, and company profiles, which together comprise and discuss views on the emerging & high-growth segments of the global starter cultures, high-growth regions, countries, government initiatives, drivers, restraints, opportunities, and challenges.

Reasons to buy this report: To get a comprehensive overview of the bone & joint health supplements market To gain wide-ranging information about the top players in this industry, their product portfolios, and key strategies adopted by them To gain insights about the major countries/regions in which the bone & joint health supplements market is flourishingRead the full report: https://www.reportlinker.com/p06288924/?utm_source=GNW

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The global bone & joint health supplements market is estimated to be valued at USD 11.7 billion in 2022. It is projected to reach USD 17.6 billion...

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9 of the best magnesium supplements – Medical News Today

We include products we think are useful for our readers. If you buy through links on this page, we may earn a small commission. Heres our process.

Magnesium is a mineral that is vital for human health and is available in many foods. People who need magnesium supplementation can purchase supplements online and in stores.

Research suggests that as many as two-thirds of people living in Western countries do not consume adequate amounts of magnesium. Magnesium deficiency can lead to symptoms such as arrhythmia, depression, and tremors.

This article discusses what magnesium is, the benefits of this mineral, and where to buy magnesium supplements online.

Magnesium is vital for many important bodily functions, such as:

It is widely available in many different kinds of food, such as leafy greens and whole grains. Manufacturers may add the mineral to fortified foods such as cereals.

People should always aim to consume enough magnesium through food, as food also contains a variety of other nutrients essential to health, including vitamins, protein, and other minerals. However, many people do not eat enough magnesium-rich foods and may benefit from taking a supplement.

Learn more about which foods are high in magnesium here.

There are several factors a person may look for in a magnesium supplement:

Magnesium supplements are available in different forms, such as:

Some types of magnesium are not as easy for the body to absorb, such as:

People may wish to purchase supplements that have magnesium citrate, aspartate, chloride, or lactate, as these are the more absorbable forms.

The National Institutes of Health (NIH) states that the daily magnesium needs of people of different age groups are as follows:

Those who are pregnant or breastfeeding will need different amounts of magnesium:

Medical News Today chooses products that meet the following criteria where possible:

The following table indicates how MNT chooses to rank the products within this article:

Please note that the writer of this article has not tried these products. All information presented is purely research-based and correct at the time of publication.

Medical News Today follows a strict product selection and vetting process. Learn more here.

The following are some magnesium supplements available to purchase online.

Life Extension states that the proprietary magnesium in this product is highly absorbable and does not have a laxative effect. Additionally, this product is suitable for vegetarians and does not contain GMO ingredients or gluten.

The company uses third-party labs to test each batch for safety. Additionally, people can call the companys toll-free number to receive the products certificate of analysis.

Life Extension recommends taking three capsules per day.

This product is third-party tested, and people can receive the products certificate of analysis from the company.

However, those who left more negative reviews say that they found it difficult to digest this supplement. Additionally, this product requires people to swallow three capsules.

Nature Made states that U.S Pharmacopeia tests all of its products for quality and safety. Additionally, the supplement does not contain gluten or artificial colors or flavors.

The company recommends taking one tablet per day with meals and water.

This supplement is gluten-free and third-party lab tested, which means it does not contain any ingredients that are harmful to human health.

However, this supplement may not be suitable for use on an empty stomach. The company recommends taking the tablets with meals and water.

Additionally, this product contains magnesium oxide. The body does not absorb this type of magnesium well.

This supplement offers 500 mg of magnesium per serving. It does not contain GMO ingredients and is free from many common allergens, such as soy, gluten, dairy, and fish.

The company recommends taking one tablet per day.

Each tablet is coated, which may make them easier for a person to swallow.

However, this supplement contains a high amount of magnesium and may not be suitable for everyone. Additionally, the supplement contains magnesium oxide, which the body cannot absorb easily.

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The manufacturer states that this product is vegan and does not contain any GMO ingredients. The active ingredient is magnesium bisglycinate. Additionally, it does not contain any calcium.

Nested Naturals recommends taking two capsules per day.

This supplement is suitable for vegans and does not contain any soy, gluten, or GMO ingredients.

However, This magnesium supplement is more expensive than some other options.

This supplement is free from artificial colors and sweeteners, binders, fillers, and preservatives.

Pure Encapsulations states that it manufacturers products that are suitable for people with allergies. This supplement does not contain:

The company recommends taking 1 to 4 capsules a day with food.

This product is free from most common allergens, which may make it more suitable for those with allergies and sensitivities than other products.

However, people who require four capsules of this supplement may prefer to purchase a product that contains a similar amount of magnesium in fewer capsules.

Naturelo states that this product combines magnesium glycinate chelate with a blend of organic, magnesium-rich, vegetables and seeds.

The blend includes spinach, okra, quinoa, pumpkin seed, sunflower seeds, and flaxseed.

The company recommends taking one capsule per day.

This product has third-party testing. However, the capsules may be too large for some people to swallow easily.

Live Conscious states that this supplement may help support the cardiovascular, musculoskeletal, nervous, and immune systems. Each bottle contains three different types of magnesium alongside zinc and vitamin D3.

This supplement is free from soy, gluten, dairy, and preservatives.

The company recommends taking two capsules with 8 ounces of water once per day.

Customers state that these supplements have helped improve their sleep and bowel function.

However, this product also contains zinc and vitamin D3. A person who is taking other vitamin and mineral supplements may wish to ensure that they do not exceed the daily recommended intake of zinc and vitamin D3.

This product combines magnesium with glycine, an amino acid that the manufacturer states may make the supplement easier for the body to tolerate and absorb.

The company recommends taking one capsule, 1 to 3 times per day.

These supplements are vegetarian and free from most common allergens, such as shellfish, yeast, and eggs.

Klaire Labs does not state whether its supplements are third-party lab tests. Additionally, this supplement provides a lower dose of magnesium per serving than some other products.

Rainbow Light states that this supplement has a 2:1 ratio of magnesium to calcium. The company states that it may help support healthy muscle function and recovery.

Additional ingredients include an herbal muscular support blend, a digestive support complex, and vitamins C, D3, and B6.

Rainbow Light recommends taking one tablet per day.

Some customers state that these tablets are easy to swallow and do not upset the stomach.

However, Rainbow Light does not state whether its supplements are third-party lab tested. Additionally, it contains other vitamins, and a person may wish to ensure they do not exceed their recommended daily intake if they also have multivitamins.

People may wish to consider the following factors when choosing a magnesium supplement:

Magnesium is generally safe to consume. The NIH states that the upper tolerable limit of magnesium is 350 mg per day for people aged 9 and over.

Studies show that higher doses are safe to consume. For example, 500 mg of magnesium may help improve sleep quality and reduce insomnia.

The NIH also says that consuming too much magnesium through food does not pose a health risk to most people as the kidney filters the excess mineral in the urine.

However, the main side effects of having too much magnesium supplementation include diarrhea, nausea, and abdominal cramping.

Very high doses of magnesium, often in the form of antacids, can cause magnesium toxicity. This is more common in people who consume around 5000 mg of magnesium with antacids. Symptoms of magnesium toxicity include:

If a person does not receive treatment for magnesium toxicity, they will experience:

People with kidney failure are more likely to develop magnesium toxicity as their kidneys cannot filter the excess magnesium in the urine.

Learn more about magnesium toxicity here.

Below are some common questions about magnesium.

Research on the effects of magnesium on sleep is limited.

However, one study found that taking a 500 mg magnesium supplement led to an improvement in insomnia.

People should try to take any supplements at the same time each day, as this may help form a habit and make it less likely for a person to forget to take the supplement.

However, the NIH warns that people should not take a magnesium supplement within 2 hours of oral bisphosphonates, such as Fosamax.

Additionally, people should take a magnesium supplement at least 4 to 6 hours before taking tetracycline or quinolone antibiotics, or at least 2 hours afterward.

As with any supplement, a person should consult with a healthcare professional before taking magnesium. People with kidney conditions face a higher risk of side effects.

A healthcare professional will advise whether it is safe to take magnesium after checking a persons health conditions and any medications they take.

Magnesium is a vital mineral for human health. However, many people do not consume enough of this mineral through food and may need supplementation. There are several magnesium supplements available to purchase online.

However, taking too much magnesium may lead to nausea, abdominal cramping, and diarrhea. People should always consult with a healthcare professional before deciding to take magnesium supplements.

See more here:
9 of the best magnesium supplements - Medical News Today

Recommendation and review posted by Bethany Smith

Wellness Supplements Market Detailed Analysis Of Current Industry Demand with Forecasts Growth by 2028 Designer Women – Designer Women

Wellness Supplements Market research report brings to light key market dynamics of sector. The report gives correct insights on the current market scenario and future prospects of the industry. It neatly describes historic data, present market trends, market environment, technological improvements, upcoming technologies and the technical progress in the related industry. Major market players, major collaborations, mergers & acquisitions are reviewed comprehensively in the market report. Moreover, this market study also analyzes the market status, market share, growth rate, future trends, market drivers, opportunities and challenges, sales channels, distributors and Porters Five Forces Analysis. Market risks and entry barriers makes industry attentive and help deciding further moves.

Moreover, two more major success factors of the credible market report can be mentioned here which are market share analysis and key trend analysis. The research methodology employed in the report by DBMR research team is data triangulation which includes data mining, studying the impact of data variables on the market, and primary validation by industry experts. Being an outstanding and a comprehensive in nature, this report focuses on primary and secondary market drivers, market share, leading segments and geographical analysis. With the nice mixture of integrated approaches and latest technology, best results are achieved in the form of this market research report.

Wellness supplements market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 386.29 billion by 2027 growing at a CAGR of 6.45% in the above-mentioned forecast period. The growing awareness towards healthy lifestyles among the people globally will help in driving the growth of the wellness supplements market.

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Top Companies of Industry

The major players covered in the wellness supplements market report are Life Extension, OPTAVIA LLC, Beachbody LLC, Natures Sunshine Products, Inc, Organo Gold., Thrive Life, LLC, Phytoscience Trvo, Oriflame Cosmetics AG, Melaleuca Inc, Shaklee Corporation, Arbonne International, LLC., Forever Living.com, L.L.C, Juice Plus+, Herbalife International of America, Inc, and Isagenix Worldwide LLC, Nikken Inc., Wellness Resources, Inc., The Daily Wellness Company, Otsuka Holdings Co. Ltd, Glanbia plc, Nestle, Nuskin, USANA Health Sciences, Inc., among other domestic and global players. Market share data is available for Global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

The Objective of This Report:

The Wellness Supplements Market report is a comprehensive research that focuses on the overall consumption structure, development trends, sales models and sales of top countries in the Wellness Supplements Market. The report focuses on well-known providers in the Wellness Supplements Market industry, market segments, competition, and the macro environment.

Under COVID-19 Outbreak, how the Wellness Supplements Market Industry will develop is also analyzed in detail in this report.

Global Wellness Supplements Market, By Dietary Supplements (Vitamin, Mineral, Botanical, Probiotics, Fatty Acid, Protein, Others), Functional Food and Beverage (Functional Bakery and Confectionary, Functional Dairy, Energy Drink, Sports Drink, Infant Formula and Baby Food, Others), Nutricosmetics (Skin Care, Hair Care, Weight Management, Others), Free From Food (Gluten- Free, Lactose-Free, Trans- Free, Others), Country (U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East & Africa) Industry Trends and Forecast to 2027

The current trend pertaining to the demand supply and sales together with the recent developments have been given here to provide an exhaustive picture of this market. It also allows voluntarily accessible affordable reports of the research that is the end result of the personalized research carried by the internal team of professionals.

To comprehend Wellness Supplements Market dynamics in the world mainly, the Wellness Supplements Market is analyzed across major global regions.

Actual Numbers & In-Depth Analysis, Business opportunities, Market Size Estimation Available in Full Report.

Competitive Landscape and Wellness Supplements Market Share Analysis

Wellness supplements market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to wellness supplements market.

Increasing ageing population, raising disposable income in developing countries and rising demands towards the healthy and cosmetic products will likely to accelerate the growth of the wellness supplements market in the forecast period of 2020-2027. On the other hand, gradual shift towards newer technologies and natural products and growth potential offered by emerging markets will further boost various opportunities that will lead to the growth of the wellness supplements market in the above mentioned forecast period.

Lack of traditional food categories, high cost of supplement food products, regulatory issues and increasing incidence of health issues will likely to hamper the growth of the wellness supplements market in the above mentioned forecast period.

Accomplishment of maximum return on investment (ROI) is one of the most wannabe goals for any industry which can be achieved with the finest Wellness Supplements Market research report. Market insights of this report will direct for an actionable ideas, improved decision-making and better business strategies. The main research methodology utilized by DBMR research team is data triangulation which entails data mining, analysis of the impact of data variables on the market, and primary validation. The Wellness Supplements Market report is mainly delivered in the form of PDF and spreadsheets while PPT can also be provided depending upon clients request. To achieve an inevitable success in the business, this Wellness Supplements Market report plays a significant role.

Key Pointers Covered in the Wellness Supplements Market Industry Trends and Forecast to 2027

Global Wellness Supplements Market Scope and Market Size

Wellness supplements market is segmented on the basis of dietary supplements, functional food and beverage, nutricosmetics and free from food. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Wellness Supplements Market Country Level Analysis

Wellness supplements market is analysed and market size insights and trends are provided by country, dietary supplements, functional food and beverage, nutricosmetics and free from food as referenced above.

The countries covered in the wellness supplements market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the wellness supplements market due to growing cognizance and acceptance of wellness products and increasing focus towards healthy lifestyles while Asia-Pacific is expected to grow at the highest growth rate in the forecast period of 2020 to 2027 due to rising aging population and growing disposable income of the region.

The country section of the wellness supplements market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

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Healthcare Infrastructure growth Installed base and New Technology Penetration

Wellness supplements market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for wellness supplements market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the wellness supplements market. The data is available for historic period 2010 to 2018.

Wellness Supplements Market Development

Table of Contents-Snapshot

Executive SummaryChapter 1 Industry OverviewChapter 2 Industry Competition by ManufacturersChapter 3 Industry Production Market Share by RegionsChapter 4 Industry Consumption by RegionsChapter 5 Industry Production, Revenue, Price Trend by TypeChapter 6 Industry Analysis by ApplicationsChapter 7 Company Profiles and Key Figures in Industry BusinessChapter 8 Industry Manufacturing Cost AnalysisChapter 9 Marketing Channel, Distributors and CustomersChapter 10 Market DynamicsChapter 11 Industry ForecastChapter 12 Research Findings and ConclusionChapter 13 Methodology and Data Source

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Wellness Supplements Market Scope

Wellness supplements market is segmented on the basis of countries into U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

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Insights of the Market in Report

1. The study provides an in-depth analysis of the Wellness Supplements Market along with the current trends and future estimations to elucidate the imminent investment pockets.

2. Comprehensive analysis of the factors that drive and restrict the market growth is provided in the report.

3. Comprehensive quantitative analysis of the industry is provided for the period of 2018-2025 to assist stakeholders to capitalize on the prevailing market opportunities.

4. Extensive analysis of the key segments of the industry helps in understanding the trends in types of Wellness Supplements Market across Glob.

5. Key market players and their strategies have been provided to understand the competitive outlook of the Wellness Supplements Market industry

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Wellness Supplements Market Detailed Analysis Of Current Industry Demand with Forecasts Growth by 2028 Designer Women - Designer Women

Recommendation and review posted by Bethany Smith

Hospitals bound to patient safety rules that aren’t all backed by evidence – EurekAlert

CHICAGO --- If health care facilities such as hospitals and nursing homes dont follow patient safety rules set by The Joint Commission (TJC) the independent organization responsible for accrediting health care facilities they may lose their accreditation, and consequently, lose patients and millions of dollars every year in funding.

But what if those rules arent supported by evidence?

A new Northwestern Medicine study found of the new rules issued during a one-year period by the TJC, many did not appear to be supported by published evidence. The study showed only six of 20 rules were directly supported by references cited by TJC, six were partly supported and eight were not supported at all.

This paper is among the first to show that TJC may issue rules or standards for hospitals, nursing homes and other health care facilities that are not backed by evidence showing these are necessary or important for patient safety or health.

While this study only reviewed new rules during a one-year period, the implication is that many rules issued in the past may similarly not be supported by published evidence, the study authors said.

The study will be published June 23 in the British Medical Journal.

Why does it matter?

Following the rules or standards set by TJC can be expensive and use hospital resources and staff time, said lead study author Dr. Murad Alam, vice chair and professor of dermatology at Northwestern University Feinberg School of Medicine and a Northwestern Medicine physician. "In fact, we started this study because we were approached by colleagues frustrated by TJC rules. As an example, TJC requires hospitals to discard drugs past their printed expiration dates, which results in billions wasted every year, even though the FDA's own Self Life Extension Program has shown that most of the drugs tested were perfectly safe and effective for many years longer.

Because TJC rules are so influential and impactful, it is important that these rules really improve patient care and safety. Our finding is concerning because unhelpful rules can waste money in the health care system and take attention from more important activities.

A common way to justify a rule is to show that evidence, including previous medical studies, improve the quality or safety of care. TJC, when issuing new standards and rules, often lists citations, or the names of medical articles it believes show the value of these rules, Alam said.

However, when the study authors went back to read these articles listed in support of the new rules, they found, in many cases, the articles provided little to no convincing information that the particular standards or rules being recommended by TJC would improve safety or quality of care.

Hundreds of millions of patients, hospital employees, staff affected by TJC rules

Potentially hundreds of millions of patients and millions of hospital employees and staff are affected by TJC rules and standards since the vast majority of U.S. hospitals are accredited by the Joint Commission.

We all pay the cost, in terms of insurance premiums and out-of-pocket health expenses, to ensure that hospitals are safe and high quality, with some of this going to make sure that TJC standards are followed, Alam said.

Given that money for health care is limited, we want to make sure that our dollars are being used to truly ensure safety and quality and not just to do busy work that sounds important but doesnt really make a difference in how patients fare, Alam said.

When TJC standards are not supported by evidence, if TJC still believes these are important, they should provide patients, doctors and administrators with other reasons why these standards should be implemented, he said.

In medicine, evidence is often the basis of what we do or dont do, and doctors, researchers and regulators are expected to be transparent in sharing the evidence that influences their behavior, Alam said.

Alam stressed the paper is not critical of TJC's mission, motives or importance.

TJC standards are important and often extremely helpful in making health care very safe and in reducing medical errors, Alam said. We must give a great deal of credit to TJC for being at the forefront of protecting patients in the U.S. We also admire TJC for constantly striving to improve health care safety and quality by considering new standards that may further reduce medical errors. This is an outstanding organization, which we are fortunate to have.

The authors suggest:

The article is titled: The evidence base for US joint commission hospital accreditation standards: cross sectional study.

This study was funded by Feinbergs department of dermatology, section of cutaneous surgery.

Data/statistical analysis

Not applicable

The evidence base for US joint commission hospital accreditation standards: cross sectional study.

23-Jun-2022

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Hospitals bound to patient safety rules that aren't all backed by evidence - EurekAlert

Recommendation and review posted by Bethany Smith

Tessara’s Berrisys Fast is quick to unlock the potential of raspberries and blackberries – FreshPlaza.com

In response to requests from raspberry and blackberry growers, Tessara has developed Berrisys Fast, a fully recyclable sulphur dioxide-generating sheet, with only a fast release layer, activated at high relative humidity in order to protect these most delicate of fruit.

Blueberries are climacteric fruit and will continue to ripen after harvest and can be stored and transported for long periods, while non-climacteric fruit such as raspberries and blackberries will not ripen and need to be harvested at full or close to full maturity.

Elton Williams, research scientist and custodian of berries at Tessara, explains that with the successful development of Berrisys and Berrisys LITE for blueberries, Tessara has invested in various experiments since 2018 and has until now started working closely with local raspberries and blackberries growers in South Africa.

"Storage and transport periods on raspberries and blackberries are very short and this is due to the rapid deterioration, from fruit senescence and postharvest diseases," he says.

Major losses can be experienced and an entire pallet of fruit can be unfit for consumption and can therefore be rejected.

We are in the process of releasing Berrisys Fast into the market that contains the same active ingredient, as our popular Berrisys and Berrisys LITE for blueberries, but it differs from these products in terms of the time frame."

The idea is to develop a product for short term protection against postharvest diseases during storage and transport, without negatively affecting other quality parameters such as the natural flavours and colour, he adds.

Whereas Berrisys and Berrisys LITE are dual-release laminated sheets which release an initial higher amount of SO2 over 24 to 48 hours, followed by a lower dosage offering 30 to 42 days of protection, Berrisys Fast only releases SO2 during the first 24 to 48 hours.

Precise concentrations and particle sizes of the active ingredient control the gas concentration and active period of the fast release layer. The fast release layer disinfect the surface of the berries, by releasing a large enough dose of sulphur dioxide to kill and eliminate any actively growing Botrytis (grey mould) fungal spores and to offer immediate protection over the three to four days of airfreight transit or during the storage period.

A blackberry orchard

Shelf life extension of a day and a halfElton points out that raspberries and blackberries have an exceedingly short shelf life and postharvest losses due to Botrytiscan be devastating. Sulphurous acid is formed when SO2 gas reacts with water. Sulphurous acid reacts with the cell membrane and block enzymes of microorganisms and therefore inhibits the multiplication of micro-organisms present on the surface of fruit. While other packaging solutions may delay fruit respiration while the packaging remains intact, the moment conditions change, any spores present will inevitably continue its life cycle.

Moreover, given logistical uncertainties for example temperature fluctuations which are at times an unavoidable reality and can thus lead to condensation within packaging, inviting the development of mould on fruit. The only certain way to protect fruits is by destroying the viability of spores in the first place.

Gerhard Slabbert, Berrisys global product manager, observes that in the current challenging trading environment, it is imperative that berry growers investigate all possible avenues to safeguard the quality of ephemeral products like raspberries and blackberries. Weve had great success in our trials of the Berrisys Fast, while an independent trial in Australia has replicated our results: with Berrisys Fast it is possible to obtain an extension of a day and a half in shelf life, he says.

Tessaras initial focus will be on South African-grown raspberries and blackberries, two categories that have been more under the radar than blueberries, but which have witnessed a steady growth in exports, mostly to the United Kingdom, followed by the Middle East.

For the moment, regulations in the EU governing the use of sulphur dioxide hold back its introduction to raspberry and blackberry growers, but Lionel George, head of regulatory and compliance at Tessara, notes that the company has approached the relevant authorities for amendments to the regulatory framework which they expect could take up to two years.

The argument in favour of sulphur dioxides salient ability to preserve fruit quality and thus reduce food waste is incontrovertible, the company maintains, and it is pursuing regulatory registration trials of Berrisys and Berrisys LITE for blueberries in the USA and Australia.

The Berrisys Fast sheet for raspberries and blackberries (photo supplied by Tessara)

The past season offered a trial by fire for Berrisys on blueberries: it was clear that berries sent under a Berrisys regime handled the huge delays much better than those without. Elton observes that one of their clients had blueberries in transit for an extended period due to delays and nevertheless still managed to sell most of that fruit. He remarks that none of their trials had ever run for such a long period of time.

Realistically, we have to plan for the impact of longer storage periods with the holdups at harbours, both here and on the receiving end, he says.

For more information:Gerhard SlabbertTessara BerrisysTel: +27 82 094 1875Email: gerhards@tessara.co.zahttps://www.tessara.co.za/products/berrisys-2/

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Tessara's Berrisys Fast is quick to unlock the potential of raspberries and blackberries - FreshPlaza.com

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Testosterone May Aid Memory in Men With Uncontrolled Diabetes – Everyday Health

Some men with a deficit of sex hormones who take testosterone replacement therapy may experience a benefit that goes beyond improved sexual function.

When men have both hypogonadism and poorly controlled type 2 diabetes, testosterone replacement therapy may improve both sexual function and cognitive function, according to preliminary results of a small clinical trial presented at the Endocrine Societys annual meeting in Atlanta.

The findings are welcome news to men with diabetes and hypogonadism, since they often have a poor quality of life, said the lead study author, Preethi Mohan Rao, MD, of the University of Sheffield, England, in a statement.

Hypogonadism in men, often called low T, develops when the body doesnt produce enough testosterone. While men can be born with the condition, it can also develop later in life and cause symptoms like reduced sex drive, erectile dysfunction, depression, and difficulty concentrating, according to the Mayo Clinic. Not all men with hypogonadism have symptoms, and testosterone replacement therapy is recommended only when they do, according to the Endocrine Society.

Sexual dysfunction is a common symptom of both hypogonadism and type 2 diabetes. Men with type 2 diabetes have about twice the risk of low testosterone, according to the American Diabetes Association. Men with poorly controlled diabetes or obesity, or both, have an even greater risk of low testosterone.

For the new clinical trial, researchers randomly assigned 65 men with hypogonadism and poorly controlled type 2 diabetes to take either placebo shots or injections of testosterone replacement therapy every 12 weeks for six months. Then researchers extended the trial for an additional six months, continuing treatment for men on testosterone and starting testosterone for men in the placebo group.

Over the first six months of the trial, men who took testosterone experienced significantly bigger improvements in quality of life and a larger reduction in symptoms associated with low testosterone.

When these men continued testosterone for an additional six months, they experienced overall symptom improvements as well as increased sexual function and libido, the trial found. In addition, these men performed significantly better on delayed verbal recall tests, assessments done to detect early signs of dementia.

The trial was small, however, and more research is needed before health practitioners change treatment approaches for men with hypogonadism and type 2 diabetes.

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Testosterone May Aid Memory in Men With Uncontrolled Diabetes - Everyday Health

Recommendation and review posted by Bethany Smith

Cardiovascular Effects of Androgen Deprivation Therapy in Prostate Cancer Patients: A Systematic Review – Cureus

In developed countries where there are large populations of older men, prostate cancer becomes a serious public health problem as its prevalence increases throughout life. In the United States, following lung cancer, prostate cancer is the second-highest cause of cancer death in males, with one estimate claiming that 1.3 million newly diagnosed cases of prostate cancer were recorded in men in 2018 associated with 359,038 deaths [1].

Since the first observation by Huggins and Hodges in 1941, it has been established that androgens (chiefly testosterone) play a key role in promoting tumor growth in prostate cancer patients [2]. Hence, effective anti-cancer therapy revolves around declining exposure to androgens and is referred to as androgen deprivation therapy (ADT). ADT is frequently used with localized treatments such as external beam radiotherapy or brachytherapy [3]. Even though orchiectomy (surgical castration) is a simple and cheap procedure, it is less common due to its irreversibility [4]. Multiple strategies are employed to reduce exposure to testosterone including surgically removing the testes that produce 90% of the hormone or undergoing hormonal therapy which entails either reducing testosterone secretion or blocking androgen receptors. Figure1depicts the hypothalamic-pituitary-gonadal axis and the sites of action of ADT.

ADThas become more common in prostate cancer patients in recent yearswith approximately 40% of men undergoing ADT within six months of diagnosis [5]. Cooperberg and colleagues documented the significant increase in the use of ADT from 1989 to 2001 in their report. The most dramatic change was the increase in the use of ADT in external beam radiation therapy (RT) from 9.8% to 74.6% of patients [6].

The use of ADT in prostate cancer treatment has expanded beyond symptomatic metastatic diseasetreatment to include asymptomatic metastatic disease, primary treatment in localized disease when men are unable to undergo surgery or radiotherapy, adjunct therapy in high-risk diseases treated with radiotherapy, and salvage therapy after relapse after surgery or radiotherapy for presumed localized disease [7,8]. TheEuropean Association of Urology (EAU) guidelines recommend ADT for patients with metastatic disease (level of evidence: A) or combined with RT for individuals with high-risk cancers (level of evidence: A). Further, ADT can be used as a single treatment for men with advanced prostate cancer who refuse, are incapable to take any other form of local treatment, or are asymptomatic, with a prostate-specific antigen (PSA) higher than 50 ng/mL and a tumor that is not well-differentiated (level of evidence: A) [9].

A profound testosterone deficiency created by ADT can cause various adverse short and long-term health effects, including hot flushes, sexual dysfunction, obesity, sarcopenia, dyslipidemia, hyperinsulinemia, osteoporosis, type 2 diabetes mellitus (DM), and cardiovascular disease (CVD) [5,7,8]. Despite the fact that male sex is a known risk factor for coronary artery disease (CAD), evidence is mounting that testosterone may protect men with prostate cancer and men in general against heart disease [8].ADT has been shown to promote adiposity in males; one study reported that after one year of ADT, body fat increased by 9.4% [10].

Most patients with prostate cancer have CVD as comorbidity [11-13]. In men with prostate cancer, CVD is the leading cause of non-cancer mortality. In the mid-1990s, Surveillance, Epidemiologyand End Result (SEER) Medicare-linked data showed that CVD was responsible for around one-fourth of deaths among men with prostate cancer [14]. This piqued the researchers interest in determining what might be causing CVD in this group, focusing on the role of ADT as a contributory factor. In 2010, the American Heart Association, the American Society for Radiation Oncology, and the American Urological Association issued a joint statement to raise awareness of the ADT-CVD relationship [15].

In males with prostate cancer, significant increases in total blood cholesterol and triglyceride levels have also been related to androgen deficiency [16]. CAD is exacerbated by obesity and hyperlipidemia, both of which are risk factors[16]. ADT also raises hemoglobin A1C levels in men who already have DM [17]. Although more research is needed to demonstrate that the link between CVD and ADT is not due to confounding factors, there are multiple physiologically possible mechanisms through which ADT may contribute to CVD development [17].

Dyslipidemia, DM, and obesity are all well-known possible causes of atherosclerotic CVD [18]. Androgens may influence the local inflammatory response, which plays a critical role in the formation of atherosclerotic plaques, as well as plaque instability and rupture, via androgen receptor (AR)-dependent and AR-independent pathways, according to recent studies [17]. As a result, these consequences of medically induced hypogonadism may provide a mechanism through which ADT may raise the risk of cardiac morbidity and mortality. Hence, a thorough systematic review of published papers was performed to precisely analyze the relationship of ADT with cardiovascular events in prostate cancer patients and to assist healthcare providers in making related clinical decisions [10].

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards were used to perform this systemic review [19].

Database and Search Strategy

The research was started on November 20, 2021, using online libraries as our database. We searched PubMed, Scopus, Science Direct, and Google Scholar for data collection. Our keywords and medical subject heading (MeSH) search strategiesused are depicted in Table 1.

Eligibility Criteria

Studies investigating the association of ADT with cardiovascular events in prostate cancer patients were included without geographic location or publication status restrictions. The following selection criteria were included: (1) the study was published as an original article and contained the original data (excluding reviews, editorials, and conference summaries); (2) only included patients diagnosed with prostate cancer; (3) the intervention group included ADT (medical or surgical ADT); (4) studies with cardiovascular outcomes as the endpoint. Studies were excluded if any of the following factors were identified: (1) secondary studies; (2) laboratory studies; (3) animal studies; (4) database duplication and lack of detailed results.

Quality Assessment Tools

The assessment was separately conducted by two independent reviewers using the Cochrane risk bias assessment tool for clinical trials and the modified version of the Newcastle-Ottawa Scale (NOS) for quality assessment of observational studies [19]. With the help of another field expert, all discrepancies regarding the inclusion of the studies were resolved. High-quality studies were defined as those that received 70% or more of the highest number of stars. We excluded studies that were of low quality. In total, 16 studies were included [4,19-33]. Table 2 shows the quality assessment of clinical trials using the Cochrane Risk of Bias Tool.

Table 3 shows the quality assessment ofcohort studies using the modified version of the NOS.

Table 4 shows the quality assessment of cross-sectional studies using the modified version of the NOS.

Selection and Data Extraction

Two reviewersseparately obtained data utilizing a predefined data extraction formfrom the final articles after quality assessment. With the help of a third reviewer, disagreements were addressed via debate or consensus.The following information was obtained: first authors name, sample size, research features (i.e., year, design, and setting), type of ADT intervention used in the study, cardiovascular events described in every paper, and other non-cardiovascular events described in the study. Extracted data are summarized in Table 5.

Literature Search

Our extensive search resulted in 425 studies. Only 287 studies remained after removing 108 duplicates. In total, 264 articles were omittedafter reviewing the abstractsand titles because they did not fit the inclusion criteria forthe following causes: secondary studies, laboratory searches, and non-relevant topics. Finally, the entire paper was carefully read, of which five were further excluded because of non-cardiovascular end-point. Figure 2 shows the PRISMA flowchart demonstrating the search process and study selection.

Study Characteristics

In total, 14 observational studiesand two randomized control trials (RCTs ) were included in the systemic review [4,19-33]. The key characteristics of the investigations (published between 2006 and 2020) that were considered are listed in Table 5. Seven studies were performed in America, one in Japan, two in Sweden, one in China, two in Canada, one in Taiwan, and one in Brazil. One clinical trial was done in the United States, Australia, and Canada. The sample sizes in the reviewed clinical investigations ranged from 79 to 201,797 participants. All studies had ADT as the intervention.

Seven of these studies did not mention the specific ADT type used and compared outcomes between patient groups that used ADT to those that did not.The other studies mention the specific type of ADT used and compared the outcomes between patient groups receiving different types of ADT such as GnRH agonists, combined androgen blockade (CAB), surgical castration, and oral anti-androgenwith each other and with the patient group that did not receive ADT.

ADT Versus Non-ADT Groups on Cardiovascular Events

Myocardial infarction (MI), sudden cardiac death (SCD), and CAD: According to a study by Wallis et al., radiation (adjusted hazard ratios (aHR) = 1.16-1.28, p< 0.0001-0.04) and ADT (aHR = 1.18-1.32, p< 0.0001-0.0008) were both linked with an elevated risk of CAD, SCD, and fracture requiring hospitalization after adjusting for baseline differences [32].Radiotherapy was associated with a greater risk of MI (aHR = 1.20, p = 0.02) but not ADT (p = 0.5) [32].In a study by Nguyen et al., individuals who used ADT had a greater risk of CAD (HR = 1.12, 95% confidenceinterval (CI) = 1.09-1.14) and acute MI(HR = 1.11, 95%CI = 1.08-1.15) than those who did not [33].

Standardized incidence ratio(SIR) of CVD, arrhythmia, and ischemic heart disease (IHD): Van Hemelrijck et al. reported thatregardless of the history of cardiovascular illness, SIRfor CVD was high in all males undergoing ADT, with the greatest values among those on endocrine treatment [31]. In this study, endocrine treatment was grouped into anti-androgens, estrogens, orchiectomy, GnRH agonists, GnRH agonist combined with long-term anti-androgens, and other types of endocrine therapy. SIR MI for men without circulatory disease history: 1.40 (95% CI = 1.31 to 1.49), 1.15 (95% CI = 1.01 to 1.31), and 1.20 (95% CI = 1.11 to 1.30) for men undergoing primary endocrine therapy, radical prostatectomy/radiotherapy, and surveillance endocrine therapy, respectively.

Arterial stiffness: Within six months following ADT, the entire sample exhibited no significant increase in arterial stiffness, according to Oka et al., although 55.2% of patients had an elevated cardio-ankle vascular index (CAVI) [28]. Total cholesterol, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) levels in the blood significantly increased one month after starting ADT and remained high thereafter.

Hypertension: Over a five-year follow-up period,Wu et al. found that the incidence of new-onset hypertension was 22.6 per 1,000 person-years in patients who did not receive ADT and 33.0 per 1,000 person-years in those who did receive ADT [4]. There was a 1.78-fold enhanced risk of developing new-onset hypertension in the group that received ADT than in the control group (95% CI = 1.61-1.96; p < 0.001). Furthermore, the CAB group had almost doubled the likelihood of subsequent hypertension (aHR = 1.93; 95% CI = 1.71-2.18; p < 0.001).

Cardiovascular morbidity: According to Saigal et al., patients with prostate cancer who had ADT for at least one year had a 20% greater risk of substantial cardiovascular morbidity than those who did not [29]. The individuals began to encounter this elevated risk after just 12 months of treatment.

Cardiovascular mortality: According to Kim et al., patients with no ADT, six months of ADT, and more than six months of ADT, respectively, had cumulative cardiovascular mortality of 2.6% (95% CI = 1.9-3.5%), 2.1% (95% CI = 1.2-3.5%), and 1.4% (95% CI = 1.0-2.0%) at seven years (Grays p = 0.002) [25]. In this study, compared to the more than six-month ADT group, the non-ADT group had greater cardiovascular disease and risk factors at the start.

GnRH Agonist Versus Surgical Castration Versus CAB Versus Anti-androgenson Cardiovascular Events

General risk of CVD: According to a study by O'Farrell et al., males who used GnRH agonists (HR = 1.21, 95% CI = 1.18-1.25) had a greater risk of CVD than the orchiectomy group (HR = 1.16; 95% CI = 1.08-1.25) and that of the anti-androgen group(HR = 0.87; 95% CI = 0.82-0.91) [27]. CVD risk was higher in males who had two or more cardiovascular incidents before starting ADT, with HR of CVD with GnRH agonist treatment of 1.91 (95%CI = 1.66-2.20), HR of CVD with anti-androgen therapy of 1.60 (95%CI = 1.24-2.06), and HR of CVD with orchiectomy of 1.79 (95%CI = 1.16-2.76) versus comparison cohort. Teoh et al., according to the Kaplan-Meier analysis, determined that the orchiectomy group had a higher incidence of new cardiovascular thromboticevents than the GnRH agonist group (p = 0.014) [30]. Age (HR = 1.072, 95% CI = 1.04-1.11; p = 0.001), hyperlipidemia (HR = 2.455, 95%CI = 1.53-3.93; p = 0.001), and orchiectomy (HR = 1.648, 95%CI = 1.05-2.59; p = 0.031) were all found to be significant risk factors for cardiovascular thrombotic events according to multivariate Cox regression analysis.

CVD prevalence: In a study by Morgia et al., a total of 1,075 people were included, with 285 (26.51%) and 790 (73.49%) being discordant and concordant, respectively, according to the EAU criteria [26].Discordant ADT was linked to a higher incidence of cardiovascular issues (odds ratio (OR) = 2.07; p = 0.01) in a multivariate logistic regression analysis adjusted for confounding factors, with GnRH agonists (HR = 3.95, 95% CI = 1.01-15.34; p = 0.005) and CAB (HR = 3.37, 95% CI = 1.10-10.30; p = 0.005) both contributing to cardiovascular complications.

CAD, MI, and SCD: According to Keating et al., treatment with GnRH agonists was linked to statistically significantly greater risks of incident CAD (aHR = 1.19, 95% CI = 1.10-1.28), MI (aHR = 1.28, 95% CI = 1.08-1.5) [23,24]. Oral anti-androgen monotherapy was not linked to any of the outcomes investigated. According to Gandaglia et al., overall, the rates of CAD, MI, and SCD were 25.9%, 15.6%, and 15.8%, respectively after 10 years [21]. After stratification by ADT status (ADT-naive vs. GnRH agonists vs. bilateral orchidectomy), the CAD rates were 25.1%, 26.9%, and 23.2%, respectively. The acuteMI rates were 14.8%, 16.6%, and 14.8%, while the SCD rates were 14.2%, 17.7%, and 16.4%, respectively. GnRH agonists (all p = 0.001) but not bilateral orchidectomy (all p = 0.7) were linked to a greater risk of CAD, MI, and SCD in competing-risk multivariable regression models. According to Amico et al., males aged 65 and over who got six months of ADT had shorter delays to fatal MIs than men in this age group who did not get ADT (p = 0.017) or men younger than 65 years (p = 0.016) [19]. The time to fatal MIs in males aged 65 and older who got six to eight months of ADT compared to three months of ADT revealed no significant difference (p = 0.97). Here, ADT used was GnRH agonists.

Peripheral arterial disease (PAD) and venous thromboembolism (VTE): GnRH agonist usage was linked to a greater risk of PAD (aHR = 1.16; 95% CI = 1.12-1.21) and VTE (aHR = 1.10;95% = CI 1.04-1.15). Orchiectomy was also linked to an elevated risk of PAD (aHR = 1.13; 95% CI = 1.02-1.26) and VTE (aHR = 1.27; 95% CI = 1.11-1.45), according to Hu and colleagues [22].

Cardiovascular mortality: According to Efstathiou et al., cardiovascular mortality was 5.9% for men getting longer-term adjuvant goserelin versus 4.8% for men receiving short-term goserelin after five years (Grays p = 0.16). In multivariate analyses, the treatment arm was not linked to an enhanced risk of cardiovascular mortality when censoring at the time of salvage goserelin (aHR= 1.02, 95% CI = 0.73-1.43; p = 0.9) [20]. Traditional cardiac risk variables such as age, CVD, and DM were all linked to a greater risk of CVD [20].

Systematic reviews are considered the highest level of evidence and are typically emphasized in evidence-based practice because they reduce the errors and biases that can be introduced by single research. A well-conducted systematic review can assist researchers in objectively establishing the boundaries of what is known and what is unknown by summarizing all of the relevant and reliable evidence to enhance clinical decision-making [34,35]. This review attempted to involve all potentially relevant literature related to the research topic, which was cardiovascular events due to ADT in prostate cancer patients.

ADT may be beneficial to prostate cancer patients as part of curative treatment or as a palliative treatment for advanced disease. As the average life expectancy for males with prostate cancer increases, more people may be exposed to the possible adverse effects of ADT over longer periods. Care for cardiovascular events is an important element of the survivorship phase for a significant number of prostate cancer patients.

The 16articles considered in the review were good quality studies as per the NOS andCochrane risk bias assessment tools,out of which 14 were observational studies and two RCTs. Seven of these studies did not mention the specific ADT type used and compared outcomes between patient groups that use ADT to those that did not. The other studies mentioned the specific type of ADT used and compared the outcomes between patient groups receiving different types of ADT such as GnRH agonists, CAB, surgical castration, and oral anti-androgen with each other and with the patient group that did not receive ADT.

ADT Versus Non-ADT Groups on Cardiovascular Events

According to Wallis et al., there is an increase in CAD and SCD in both the groups individually but there is an increase in MI only in the non-ADT group [32]. When discussing the risks and benefits of treatment for localized prostate cancer for formulating a survivorship plan, the increased use of ADT for males with localized disease undergoing radiotherapy, and the observed higher prevalence of CAD, MI, and SCD in these patients should be considered. Nguyen et al. conducted a study thatfound males who received ADT had a higher incidence of CAD, MI, and SCD who did not receive ADT [33].

According to Van Hemelrijck et al., all prostate cancer patients, especially those treated with ADT, have enhanced relative risks of fatal and non-fatal CVD (SIR of CVD, arrhythmia, IHD) [31].According to Oka et al., while the entire cohort did not show a significant change in arterial stiffness with ADT, some patients with CAVI showed an increase in arterial stiffness [28]. The ratio of LDL-C to HDL-C, or LDL-C/HDL-C may impact the development of arterial stiffness following ADT administration. Thus, doctors may be able to use LDL-C/HDL-C values to monitor prostate cancer patients who are at high risk of developing arterial stiffness following ADT therapy in prostate cancer patients.

According to the findings of Wu et al., males who had ADT for prostate cancer are at risk of having hypertension in the future [4]. According to Saigal et al., ADT is related to a significantly higher cardiovascular morbidity in prostate cancer patients and may reduce overall survival in low-risk men [29]. These findings are especially important for deciding whether or not to use ADT in prostate cancer patients in situations where the benefit has not been proven. According to Kim et al., individuals who received longer durations of ADT had a lower cardiovascular mortality rate than those who did not get ADT [25]. These discrepancies are most likely because of patient selection for ADT rather than the impact of ADT.

GnRH Agonist Versus Surgical Castration Versus CAB Versus Anti-androgenson Cardiovascular Events

According to Morgia et al., almost one-third of prostate cancer patients got inappropriate GnRH agonists who in turn had a higher prevalence of CVD [27]. Cardiovascular risk is significantly increased in males who received ADT in the form of GnRH agonists and surgical castration. However, prostate cancer patients who took anti-androgen had a lower chance of developing CVD risk factors. According to the findings of O'Farrell et al., there should be a strong indication for ADT in males with prostate cancer such that the benefits outweigh the risks; this is especially important in males with a recent history of CVD [28].When compared to GnRH agonists, Teoh et al. claimthat surgical castration is linked to a greater risk of cardiovascular thrombotic events. This is an essential factor to consider when choosing an ADT approach, particularly in older men with a history of hyperlipidemia [30].

GnRH agonist treatment for males with locoregional prostate cancer was linked to an elevated risk of diabetes and cardiovascular disease (CAD, MI, and SCD), according to Keating et al. (2006) [23].ADT with GnRH agonists was linked to an elevated risk of diabetes and CVD (CAD, MI, and SCD), ADT with CAB was linked to an enhanced risk of CAD, ADT with orchiectomy was linked to CAD and MI, and oral anti-androgen monotherapy was not linked to any of the outcomes studied, according to Keating (2010) [24]. In males with non-metastatic prostate cancer, Gandaglia et al. revealed that the administration of GnRH agonists, but not orchidectomy, is still associated with a considerably higher risk of CAD, MI, and, especially SCD. In men with a higher risk of CVD, alternative types of ADT should be evaluated [22]. Amico et al. discovered that GnRH agonist use is linked to an earlier onset of fatal MIs in males 65 and older who are treated for six months versus males who are not treated with GnRH agonist [19].

Hu et al. state that ADT in the forms of GnRH agonists and surgical castration for non-metastatic prostate cancer is linked to an enhanced risk of PAD and VTE. The observational research design has limitations as does the inability to examine the usage of oral anti-androgens [22].According to Efstathiou et al., a longer duration of adjuvant GnRH agonist medication does not improve cardiovascular mortality in males with locally advanced prostate cancer, whereas traditional cardiac risk factors, such as DM, prevalent CVD, and age, were significantly associated with higher cardiovascular mortality [20].

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Cardiovascular Effects of Androgen Deprivation Therapy in Prostate Cancer Patients: A Systematic Review - Cureus

Recommendation and review posted by Bethany Smith

Gene & Cell Therapy FAQs | ASGCT – American Society of Gene & Cell …

For more in-depth learning, we recommend Different Approaches in our Patient Education program.

The challenges of gene and cell therapists can be divided into three broad categories based on disease, development of therapy, and funding.

Challenges based on the disease characteristics: Disease symptoms of most genetic diseases, such as Fabrys, hemophilia, cystic fibrosis, muscular dystrophy, Huntingtons, and lysosomal storage diseases are caused by distinct mutations in single genes. Other diseases with a hereditary predisposition, such as Parkinsons disease, Alzheimers disease, cancer, and dystonia may be caused by variations/mutations in several different genes combined with environmental causes. Note that there are many susceptible genes and additional mutations yet to be discovered. Gene replacement therapy for single gene defects is the most conceptually straightforward. However, even then the gene therapy agent may not equally reduce symptoms in patients with the same disease caused by different mutations, and even the samemutationcan be associated with different degrees of disease severity. Gene therapists often screen their patients to determine the type of mutation causing the disease before enrollment into a clinical trial.

The mutated gene may cause symptoms in more than one cell type. Cystic fibrosis, for example, affects lung cells and the digestive tract, so the gene therapy agent may need to replace the defective gene or compensate for its consequences in more than one tissue for maximum benefit. Alternatively, cell therapy can utilizestem cellswith the potential to mature into the multiple cell types to replace defective cells in different tissues.

In diseases like muscular dystrophy, for example, the high number of cells in muscles throughout the body that need to be corrected in order to substantially improve the symptoms makes delivery of genes and cells a challenging problem.

Some diseases, like cancer, are caused by mutations in multiple genes. Although different types of cancers have some common mutations, every tumor from a single type of cancer does not contain the same mutations. This phenomenon complicates the choice of a single gene therapy tactic and has led to the use of combination therapies and cell elimination strategies. For more information on gene and cell therapy strategies to treat cancer, please refer to the Cancer and Immunotherapy summary in the Disease Treatment section.

Disease models in animals do not completely mimic the human diseases and viralvectorsmay infect various species differently. The testing of vectors in animal models often resemble the responses obtained in humans, but the larger size of humans in comparison to rodents presents additional challenges in the efficiency of delivery and penetration of tissue.Gene therapy, cell therapy, and oligonucleotide-based therapy agents are often tested in larger animal models, including rabbit, dog, pig and nonhuman primate models. Testing human cell therapy in animal models is complicated by immune rejections. Furthermore, humans are a very heterogeneous population. Their immune responses to the vectors, altered cells, or cell therapy products may differ or be similar to results obtained in animal models.

Challenges in the development of gene and cell therapy agents: Scientific challenges include the development of gene therapy agents that express the gene in the relevant tissue at the appropriate level for the desired duration of time. There are a lot of issues in that once sentence, and while these issues are easy to state, each one requires extensive research to identify the best means of delivery, how to control sufficient levels or numbers of cells, and factors that influence duration of gene expression or cell survival. After the delivery modalities are determined, identification and engineering of a promoter and control elements (on/off switch and dimmer switch) that will produce the appropriate amount of protein in the target cell can be combined with the relevant gene. This gene cassette is engineered into a vector or introduced into thegenomeof a cell and the properties of the delivery vehicle are tested in different types of cells in tissue culture. Sometimes things go as planned and then studies can be moved onto examination in animal models. In most cases, the gene/cell therapy agent may need to be improved further by adding new control elements to obtain the desired responses in cells and animal models.

Furthermore, the response of the immune system needs to be considered based on the type of gene or cell therapy being undertaken. For example, in gene or cell therapy for cancer, one aim is to selectively boost the existing immune response to cancer cells. In contrast, to treat genetic diseases like hemophilia and cystic fibrosis the goal is for the therapeutic protein to be accepted as an addition to the patients immune system.

If the new gene is inserted into the patients cellularDNA, the intrinsic sequences surrounding the new gene can affect its expression and vice versa. Scientists are now examining short DNA segments that may insulate the new gene from surrounding control elements. Theoretically, these insulator sequences would also reduce the effect of vector control signals in the gene cassette on adjacent cellular genes. Studies are also focusing on means to target insertion of the new gene into safe areas of the genome, to avoid influence on surrounding genes and to reduce the risk of insertional mutagenesis.

Challenges of cell therapy include the harvesting of the appropriate cell populations and expansion or isolation of sufficient cells for one or multiple patients. Cell harvesting may require specific media to maintain the stem cells ability toself-renew and mature into the appropriate cells. Ideally extra cells are taken from the individual receiving therapy. Those additional cells can expand in culture and can be induced to becomepluripotent stem cells(iPS), thus allowing them to assume a wide variety of cell types and avoiding immune rejection by the patient. The long term benefit of stem cell administration requires that the cells be introduced into the correct target tissue and become established functioning cells within the tissue. Several approaches are being investigated to increase the number of stem cells that become established in the relevant tissue.

Another challenge is developing methods that allow manipulation of the stem cells outside the body while maintaining the ability of those cells to produce more cells that mature into the desired specialized cell type. They need to provide the correct number of specialized cells and maintain their normal control of growth and cell division, otherwise there is the risk that these new cells may grow into tumors.

Challenges in funding: In most fields, funding for basic or applied research for gene and cell therapy is available through the National Institutes of Health (NIH) and private foundations. These are usually sufficient to cover the preclinical studies that suggest a potential benefit from a particular gene and cell therapy. Moving into clinical trials remains a huge challenge as it requires additional funding for manufacturing of clinical grade reagents, formal toxicology studies in animals, preparation of extensive regulatory documents, and costs of clinical trials.Biotechnology companies and the NIH are trying to meet the demand for this large expenditure, but many promising therapies are slowed down by lack of funding for this critical next phase.

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The benefits and risks of stem cell technology – PMC

Stem cell technology will transform medical practice. While stem cell research has already elucidated many basic disease mechanisms, the promise of stem cellbased therapies remains largely unrealized. In this review, we begin with an overview of different stem cell types. Next, we review the progress in using stem cells for regenerative therapy. Last, we discuss the risks associated with stem cellbased therapies.

There are three major types of stem cells as follows: adult stem cells (also called tissue-specific stem cells), embryonic stem (ES) cells, and induced pluripotent stem (iPS) cells.

A majority of adult stem cells are lineage-restricted cells that often reside within niches of their tissue of origin. Adult stem cells are characterized by their capacity for self-renewal and differentiation into tissue-specific cell types. Many adult tissues contain stem cells including skin, muscle, intestine, and bone marrow (Gan et al, 1997; Artlett et al, 1998; Matsuoka et al, 2001; Coulombel, 2004; Humphries et al, 2011). However, it remains unclear whether all adult organs contain stem cells. Adult stem cells are quiescent but can be induced to replicate and differentiate after tissue injury to replace cells that have died. The process by which this occurs is poorly understood. Importantly, adult stem cells are exquisitely tissue-specific in that they can only differentiate into the mature cell type of the organ within which they reside (Rinkevich et al, 2011).

Thus far, there are few accepted adult stem cellbased therapies. Hematopoietic stem cells (HSCs) can be used after myeloablation to repopulate the bone marrow in patients with hematologic disorders, potentially curing the underlying disorder (Meletis and Terpos, 2009; Terwey et al, 2009; Casper et al, 2010; Hill and Copelan, 2010; Hoff and Bruch-Gerharz, 2010; de Witte et al, 2010). HSCs are found most abundantly in the bone marrow, but can also be harvested at birth from umbilical cord blood (Broxmeyer et al, 1989). Similar to the HSCs harvested from bone marrow, cord blood stem cells are tissue-specific and can only be used to reconstitute the hematopoietic system (Forraz et al, 2002; McGuckin et al, 2003; McGuckin and Forraz, 2008). In addition to HSCs, limbal stem cells have been used for corneal replacement (Rama et al, 2010).

Mesenchymal stem cells (MSCs) are a subset of adult stem cells that may be particularly useful for stem cellbased therapies for three reasons. First, MSCs have been isolated from a variety of mesenchymal tissues, including bone marrow, muscle, circulating blood, blood vessels, and fat, thus making them abundant and readily available (Deans and Moseley, 2000; Zhang et al, 2009; Lue et al, 2010; Portmann-Lanz et al, 2010). Second, MSCs can differentiate into a wide array of cell types, including osteoblasts, chondrocytes, and adipocytes (Pittenger et al, 1999). This suggests that MSCs may have broader therapeutic applications compared to other adult stem cells. Third, MSCs exert potent paracrine effects enhancing the ability of injured tissue to repair itself. In fact, animal studies suggest that this may be the predominant mechanism by which MSCs promote tissue repair. The paracrine effects of MSC-based therapy have been shown to aid in angiogenic, antiapoptotic, and immunomodulatory processes. For instance, MSCs in culture secrete hepatocyte growth factor (HGF), insulin-like growth factor-1 (IGF-1), and vascular endothelial growth factor (VEGF) (Nagaya et al, 2005). In a rat model of myocardial ischemia, injection of human bone marrow-derived stem cells upregulated cardiac expression of VEGF, HGF, bFGF, angiopoietin-1 and angiopoietin-2, and PDGF (Yoon et al, 2005). In swine, injection of bone marrow-derived mononuclear cells into ischemic myocardium was shown to increase the expression of VEGF, enhance angiogenesis, and improve cardiac performance (Tse et al, 2007). Bone marrow-derived stem cells have also been used in a number of small clinical trials with conflicting results. In the largest of these trials (REPAIR-AMI), 204 patients with acute myocardial infarction were randomized to receive bone marrow-derived progenitor cells vs placebo 37 days after reperfusion. After 4 months, the patients that were infused with stem cells showed improvement in left ventricular function compared to control patients. At 1 year, the combined endpoint of recurrent ischemia, revascularization, or death was decreased in the group treated with stem cells (Schachinger et al, 2006).

Embryonic stem cells are derived from the inner cell mass of the developing embryo during the blastocyst stage (Thomson et al, 1998). In contrast to adult stem cells, ES cells are pluripotent and can theoretically give rise to any cell type if exposed to the proper stimuli. Thus, ES cells possess a greater therapeutic potential than adult stem cells. However, four major obstacles exist to implementing ES cells therapeutically. First, directing ES cells to differentiate into a particular cell type has proven to be challenging. Second, ES cells can potentially transform into cancerous tissue. Third, after transplantation, immunological mismatch can occur resulting in host rejection. Fourth, harvesting cells from a potentially viable embryo raises ethical concerns. At the time of this publication, there are only two ongoing clinical trials utilizing human ES-derived cells. One trial is a safety study for the use of human ES-derived oligodendrocyte precursors in patients with paraplegia (Genron based in Menlo Park, California). The other is using human ES-derived retinal pigmented epithelial cells to treat blindness resulting from macular degeneration (Advanced Cell Technology, Santa Monica, CA, USA).

In stem cell research, the most exciting recent advancement has been the development of iPS cell technology. In 2006, the laboratory of Shinya Yamanaka at the Gladstone Institute was the first to reprogram adult mouse fibroblasts into an embryonic-like cell, or iPS cell, by overexpression of four transcription factors, Oct3/4, Sox2, c-Myc, and Klf4 under ES cell culture conditions (Takahashi and Yamanaka, 2006). Yamakana's pioneering work in cellular reprogramming using adult mouse cells set the foundation for the successful creation of iPS cells from adult human cells by both his team (Takahashi et al, 2007) and a group led by James Thomson at the University of Wisconsin (Yu et al, 2007). These initial proof of concept studies were expanded upon by leading scientists such as George Daley, who created the first library of disease-specific iPS cell lines (Park et al, 2008). These seminal discoveries in the cellular reprogramming of adult cells invigorated the stem cell field and created a niche for a new avenue of stem cell research based on iPS cells and their derivatives. Since the first publication on cellular reprogramming in 2006, there has been an exponential growth in the number of publications on iPS cells.

Similar to ES cells, iPS cells are pluripotent and, thus, have tremendous therapeutic potential. As of yet, there are no clinical trials using iPS cells. However, iPS cells are already powerful tools for modeling disease processes. Prior to iPS cell technology, in vitro cell culture disease models were limited to those cell types that could be harvested from the patient without harm usually dermal fibroblasts from skin biopsies. However, mature dermal fibroblasts alone cannot recapitulate complicated disease processes involving multiple cell types. Using iPS technology, dermal fibroblasts can be de-differentiated into iPS cells. Subsequently, the iPS cells can be directed to differentiate into the cell type most beneficial for modeling a particular disease process. Advances in the production of iPS cells have found that the earliest pluripotent stage of the derivation process can be eliminated under certain circumstances. For instance, dermal fibroblasts have been directly differentiated into dopaminergic neurons by viral co-transduction of forebrain transcriptional regulators (Brn2, Myt1l, Zic1, Olig2, and Ascl1) in the presence of media containing neuronal survival factors [brain-derived neurotrophic factor, neurotrophin-3 (NT3), and glial-conditioned media] (Qiang et al, 2011). Additionally, dermal fibroblasts have been directly differentiated into cardiomyocyte-like cells using the transcription factors Gata4, Mef2c, and Tb5 (Ieda et al, 2010). Regardless of the derivation process, once the cell type of interest is generated, the phenotype central to the disease process can be readily studied. In addition, compounds can be screened for therapeutic benefit and environmental toxins can be screened as potential contributors to the disease. Thus far, iPS cells have generated valuable in vitro models for many neurodegenerative (including Parkinson's disease, Huntington's disease, and amyotrophic lateral sclerosis), hematologic (including Fanconi's anemia and dyskeratosis congenital), and cardiac disorders (most notably the long QT syndrome) (Park et al, 2008). iPS cells from patients with the long QT syndrome are particularly interesting as they may provide an excellent platform for rapidly screening drugs for a common, lethal side effect (Zwi et al, 2009; Malan et al, 2011; Tiscornia et al, 2011). The development of patient-specific iPS cells for in vitro disease modeling will determine the potential for these cells to differentiate into desired cell lineages, serve as models for investigating the mechanisms underlying disease pathophysiology, and serve as tools for future preclinical drug screening and toxicology studies.

Despite substantial improvements in therapy, cardiovascular disease remains the leading cause of death in the industrialized world. Therefore, there is a particular interest in cardiovascular regenerative therapies. The potential of diverse progenitor cells to repair damaged heart tissue includes replacement (tissue transplant), restoration (activation of resident cardiac progenitor cells, paracrine effects), and regeneration (stem cell engraftment forming new myocytes) (Codina et al, 2010). It is unclear whether the heart contains resident stem cells. However, experiments show that bone marrow mononuclear cells (BMCs) can repair myocardial damage, reduce left ventricular remodeling, and improve heart function by myocardial regeneration (Hakuno et al, 2002; Amado et al, 2005; Dai et al, 2005; Schneider et al, 2008). The regenerative capacity of human heart tissue was further supported by the detection of the renewal of human cardiomyocytes (1% annually at the age of 25) by analysis of carbon-14 integration into human cardiomyocyte DNA (Bergmann et al, 2009). It is not clear whether cardiomyocyte renewal is derived from resident adult stem cells, cardiomyocyte duplication, or homing of non-myocardial progenitor cells. Bone marrow cells home to the injured myocardium as shown by Y chromosome-positive BMCs in female recipients (Deb et al, 2003). On the basis of these promising results, clinical trials in patients with ischemic heart disease have been initiated primarily using bone marrow-derived cells. However, these small trials have shown controversial results. This is likely due to a lack of standardization for cell harvesting and delivery procedures. This highlights the need for a better understanding of the basic mechanisms underlying stem cell isolation and homing prior to clinical implementation.

Although stem cells have the capacity to differentiate into neurons, oligodendrocytes, and astrocytes, novel clinical stem cellbased therapies for central and peripheral nervous system diseases have yet to be realized. It is widely hoped that transplantation of stem cells will provide effective therapy for Parkinson's disease, Alzheimer's disease, Huntington's Disease, amyloid lateral sclerosis, spinal cord injury, and stroke. Several encouraging animal studies have shown that stem cells can rescue some degree of neurological function after injury (Daniela et al, 2007; Hu et al, 2010; Shimada and Spees, 2011). Currently, a number of clinical trials have been performed and are ongoing.

Dental stem cells could potentially repair damaged tooth tissues such as dentin, periodontal ligament, and dental pulp (Gronthos et al, 2002; Ohazama et al, 2004; Jo et al, 2007; Ikeda et al, 2009; Balic et al, 2010; Volponi et al, 2010). Moreover, as the behavior of dental stem cells is similar to MSCs, dental stem cells could also be used to facilitate the repair of non-dental tissues such as bone and nerves (Huang et al, 2009; Takahashi et al, 2010). Several populations of cells with stem cell properties have been isolated from different parts of the tooth. These include cells from the pulp of both exfoliated (children's) and adult teeth, the periodontal ligament that links the tooth root with the bone, the tips of developing roots, and the tissue that surrounds the unerupted tooth (dental follicle) (Bluteau et al, 2008). These cells probably share a common lineage from neural crest cells, and all have generic mesenchymal stem cell-like properties, including expression of marker genes and differentiation into mesenchymal cells in vitro and in vivo (Bluteau et al, 2008). different cell populations do, however, differ in certain aspects of their growth rate in culture, marker gene expression, and cell differentiation. However, the extent to which these differences can be attributed to tissue of origin, function, or culture conditions remains unclear.

There are several issues determining the long-term outcome of stem cellbased therapies, including improvements in the survival, engraftment, proliferation, and regeneration of transplanted cells. The genomic and epigenetic integrity of cell lines that have been manipulated in vitro prior to transplantation play a pivotal role in the survival and clinical benefit of stem cell therapy. Although stem cells possess extensive replicative capacity, immune rejection of donor cells by the host immune system post-transplantation is a primary concern (Negro et al, 2012). Recent studies have shown that the majority of donor cell death occurs in the first hours to days after transplantation, which limits the efficacy and therapeutic potential of stem cellbased therapies (Robey et al, 2008).

Although mouse and human ES cells have traditionally been classified as being immune privileged, a recent study used in vivo, whole-animal, live cell-tracing techniques to demonstrate that human ES cells are rapidly rejected following transplantation into immunocompetent mice (Swijnenburg et al, 2008). Treatment of ES cell-derived vascular progenitor cells with inter-feron (to upregulate major histocompatibility complex (MHC) class I expression) or in vivo ablation of natural killer (NK) cells led to enhanced progenitor cell survival after transplantation into a syngeneic murine ischemic hindlimb model. This suggests that MHC class I-dependent, NK cell-mediated elimination is a major determinant of graft survivability (Ma et al, 2010). Given the risk of rejection, it is likely that initial therapeutic attempts using either ES or iPS cells will require adjunctive immunosuppressive therapy. Immunosuppressive therapy, however, puts the patient at risk of infection as well as drug-specific adverse reactions. As such, determining the mechanisms regulating donor graft tolerance by the host will be crucial for advancing the clinical application of stem cellbased therapies.

An alternative strategy to avoid immune rejection could employ so-called gene editing. Using this technique, the stem cell genome is manipulated ex vivo to correct the underlying genetic defect prior to transplantation. Additionally, stem cell immunologic markers could be manipulated to evade the host immune response. Two recent papers offer alternative methods for gene editing. Soldner et al (2011) used zinc finger nuclease to correct the genetic defect in iPS cells from patients with Parkinson's disease because of a mutation in the -Synuclein (-SYN) gene. Liu et al (2011) used helper-dependent adenoviral vectors (HDAdV) to correct the mutation in the Lamin A (LMNA) gene in iPS cells derived from patients with HutchinsonGilford Progeria (HGP), a syndrome of premature aging. Cells from patients with HGP have dysmorphic nuclei and increased levels of progerin protein. The cellular phenotype is especially pronounced in mature, differentiated cells. Using highly efficient helper-dependent adenoviral vectors containing wild-type sequences, they were able to use homologous recombination to correct two different Lamin A mutations. After genetic correction, the diseased cellular phenotype was reversed even after differentiation into mature smooth muscle cells. In addition to the potential therapeutic benefit, gene editing could generate appropriate controls for in vitro studies.

Finally, there are multiple safety and toxicity concerns regarding the transplantation, engraftment, and long-term survival of stem cells. Donor stem cells that manage to escape immune rejection may later become oncogenic because of their unlimited capacity to replicate (Amariglio et al, 2009). Thus, ES and iPS cells may need to be directed into a more mature cell type prior to transplantation to minimize this risk. Additionally, generation of ES and iPS cells harboring an inducible kill-switch may prevent uncontrolled growth of these cells and/or their derivatives. In two ongoing human trials with ES cells, both companies have provided evidence from animal studies that these cells will not form teratomas. However, this issue has not been thoroughly examined, and enrolled patients will need to be monitored closely for this potentially lethal side effect.

In addition to the previously mentioned technical issues, the use of ES cells raises social and ethical concerns. In the past, these concerns have limited federal funding and thwarted the progress of this very important research. Because funding limitations may be reinstituted in the future, ES cell technology is being less aggressively pursued and young researchers are shying away from the field.

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The benefits and risks of stem cell technology - PMC

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Sernova and Evotec Enter into an Exclusive Global Strategic Partnership for iPSC-Based Beta Cell Replacement Therapy to Develop and Commercialize a…

LONDON, Ontario, May 17, 2022 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX-V:SVA)(SEOVF, Financial)(FSE/XETRA:PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics, and Evotec SE (FSE: EVT; EVO), a global pharmaceutical and life science company, and leading developer of iPSC cell technologies for therapeutic applications, are pleased to announce an exclusive global strategic partnership to develop a best-in-class cell therapy treatment for people living with insulin-dependent diabetes. The two Companies will combine and leverage their respective technologies and scientific expertise to develop an implantable iPSC-based (induced pluripotent stem cells) beta cell replacement therapy to provide an unlimited insulin-producing cell source to treat patients with insulin-dependent diabetes.

The collaboration agreement is a transformative partnership that combines Sernovas Cell Pouch System technologies, which has demonstrated Phase 1/2 clinical proof-of-concept using human donor islets, with Evotecs iPSC-based beta cells. Incorporating Evotecs insulin-producing, ethically-derived beta cells within Sernovas Cell Pouch platform creates the potential to provide a functional cure for millions of people suffering from diabetes using a cGMP controlled and scalable off-the-shelf product.

With its long-standing beta cell development program, Evotec has demonstrated the ability to reliably produce an unlimited supply of high quality, stable, human iPSC-derived beta cells using its proprietary process for producing islet-like clusters in a quality-controlled scalable bioreactor process. These islet-like clusters have now been proven to be functionally equivalent to primary human islets in their ability to normalize blood glucose using in vivo models of type 1 diabetes (T1D).

The partnership provides Sernova a global exclusive option to license Evotecs iPSC-based beta cells for use in treating both type 1 and type 2 diabetes. In addition to entering into the collaboration agreement, Evotec has made a strategic equity investment of 15M and will make a further investment of 5M. Specifically, concurrently with the entering into the collaboration agreement, Evotec acquired a total of 12,944,904 common shares at a price of CAD $1.57 per share for gross proceeds to Sernova of $20,323,500. In addition, pursuant to an unconditional purchase warrant, Evotec will acquire, on or before August 31, 2022, a further 2,709,800 common shares at a price of CAD$2.50 per share for gross proceeds of $6,774,500. All of the securities issued to Evotec are subject to a four month hold period.

Further to the collaboration and Evotecs strategic equity investment, Dr. Cord Dohrmann, Chief Scientific Officer of Evotec will join Sernovas Board of Directors.

Dr. Philip Toleikis, President, and Chief Executive Officer of Sernova, commented, In tandem with our current clinical islet cell program, Sernova entered into multiple pharmaceutical research collaborations to identify the highest quality and most compatible iPSC cell technology, and validate the cells preclinically within our Cell Pouch System. Evotec is an iPSC powerhouse having dedicated many years and substantial resources to developing high quality and stable stem cell technologies for multiple therapeutic applications. In every sense, both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and Dr. Dohrmanns appointment to Sernovas Board adds significant regenerative medicine depth and cell therapy expertise. Todays announcement of this joint iPSC beta-cell partnership completes the three pillars of our diabetes cell therapy platform. Alongside our clinically validated Cell Pouch System and recently acquired conformal coating immune protection technology, this now establishes a total regenerative medicine cell therapy solution for insulin-dependent diabetes.

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, commented, We searched long and hard for the right partner. Sernova clearly ticks all boxes with their clinically validated Cell Pouch technology, which fits perfectly to Evotecs iPSC-based beta cells. Together we will progress a highly differentiated first-in-class beta cell therapy into clinical development with the common goal to bring a truly transformative therapy to insulin-dependent diabetic patients. The synergies of Evotecs and Sernovas technologies puts Sernova in position to become the worlds leader in beta cell replacement therapy. Our equity investment underlines our strategic interest in this collaboration with Sernova. I am very much looking forward to collaborating with Sernova on the project as well as contributing to their Board of Directors.

Sernova has acquired an option for an exclusive global license to Evotecs Induced Pluripotent Stem Cell (iPSC)-based Beta cells to treat patients with insulin-dependent diabetes. From an operational perspective, the preclinical development program(s) will be jointly funded by Sernova and Evotec until IND acceptance. Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will contribute its cell manufacturing capabilities through research, development and product commercialization and will decide in the future on the joint funding of clinical development. Upon commercialization, there will be a profit-sharing arrangement between the two companies, with the split being dependent on Evotecs participation in funding the clinical development program.

Joint Sernova / Evotec Conference Call and Webcast Details:

Date: Tuesday, May 17, 2022Time: 8:30 am EDTUS Toll Free: 1-877-704-4453International: 1-201-389-0920Conference ID: 13730121Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1550130&tp_key=3de87cce1d

A simultaneous slide presentation will be available via the above webcast link.

ABOUT SERNOVA CORP AND THE CELL POUCH SYSTEM CELL THERAPY PLATFORM

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin- dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.

The Cell Pouch, as part of the Cell Pouch System, is a proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. After implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the transplantation and function of therapeutic cells, that release proteins and hormones as required to treat disease.

The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase 1/2 clinical trial study at the University of Chicago. Encouraging interim results have been presented at several international scientific conferences.

For more information, please visit http://www.sernova.com

ABOUT EVOTEC AND iPSC

Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanakas lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon for the discovery that mature cells can be reprogrammed to become pluripotent. Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotecs iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Companys proprietary EVOcells platform.

For further information contact:

Corporate and Investors:Sernova CorpChristopher Barnes Tel: (519) 858-5126 [emailprotected] http://www.sernova.com

Investors:Corey Davis, Ph.D. LifeSci Advisors, LLC [emailprotected] Tel: 212-915-2577

Media: Elizabeth Miller, MDLifeSci Communications[emailprotected]

FORWARD-LOOKING INFORMATION

This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words expects, plans, anticipates, believes, intends, estimates, projects, potential and similar expressions, or that events or conditions will, would, may, could or should occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernovas management on the date such statements were made, which include our beliefs about the conduct and outcome of clinical trials, and the development of new technologies, cell therapy solutions and or products. The information disclosed represents results from one patient and may not be representative of all study patients or of the final study results. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

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Sernova and Evotec Enter into an Exclusive Global Strategic Partnership for iPSC-Based Beta Cell Replacement Therapy to Develop and Commercialize a...

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I’m a Virus Expert and I Warn You Not to Go Here Even if it’s Open Eat This Not That – Eat This, Not That

As much as we all want the pandemic to be over, it's not. Cases are spiking in many areas and although safety precautions have been lifted, trying to avoid COVID is still recommended because there can be long lasting damaging effects that harm overall health and lingering symptoms that can continue for months. Eat This, Not That! Health spoke with different virus experts who explain what to know about COVID right now, when to still wear a mask and places to avoid in an effort to prevent getting sick. Read on to find out moreand to ensure your health and the health of others, don't miss Already Had COVID? These Symptoms May "Never Go Away".

Dr. J. Wes Ulm, Harvard and MIT-trained MD, PhD with a background in bioinformatics, gene therapy, genetics, drug discovery, consulting and education says, "That, as exhausted and fed up as we are with the pandemic, unfortunately the virus is not done with us, and we ignore its ongoing threat at our peril above all on a mass scale, as we've since learned, the danger of long COVID and cumulative organ damage from even mild cases in healthy individuals. The very name of the pathogen that causes COVID-19, SARS-CoV-2, is a bit of a misnomer, since the first four letters are an acronym for 'severe acute respiratory syndrome.' An active COVID infection indeed imperils lung function, but in the two years since its arrival shook the world, it's become clear that, more fundamentally, SARS-CoV-2 is a vascular pathogen. That is, upon gaining access to a human host (usually through a respiratory corridor like the mouth or nose, then into the airways), the virus races through the body through the ramifying blood vessels that supply virtually all our tissues. And since SARS-CoV-2 enters cells through ACE2, one of the most ubiquitous receptors in the body, it poses a serious threat across the spectrum of the body's vital organs, in a way that's rarely seen for infectious diseases.

The upshot is that, as tragic as the 1 million American deaths from acute COVID have been, the virus's most pervasive danger to US society is in its potential to gradually, progressively wreak havoc on victims' organs with each new infection accumulating damage through a thousand cuts, for perhaps tens of millions of Americans. Particularly in the last few months, physicians and researchers have managed to paint an alarming picture of just how insidious and subtly dangerous COVID is to the human body; it is not merely like a cold or flu, even if it presents that way initially for many (as does, for that matter, HIV). Multiple studies have now confirmed that even seemingly innocuous bouts of COVID-19 augment the risk of hypercoagulable states (the blood's tendency to clot) and serious sequelae like pulmonary emboli, of diabetes (both Type 1 and Type 2), of permanent lung dysfunction, of heart disease, of liver and kidney conditions, of brain damage, and of immune dysregulation. Moreover, because of SARS-CoV-2's disquieting skill at mutation and immune evasion, and our immune system's difficulty in sustainably 'remembering' the molecular hallmarks of the COVID spike protein after both vaccination and natural immunity, herd immunity is virtually impossible, and any misguided attempts to gain it with repeated infections will pose a serious danger to the organ and tissue function of a multiply infected individual. An increasingly frequent motif in many case reports is of COVID patients who experience what seem to be only mild brushes with the virus, barely sidelining them for a day or two only to suffer from a variety of documentable disorders in a range of tissues weeks or months down the road.

SARS-CoV-2, in other words, is one of the most formidable microbial foes we've ever faced as a society, possessing the contagion of measles and the capacity to disseminate systemically as few other pathogens can, alongside a fluid mutational capability that empowers it to nimbly evade the customary mechanisms of herd immunity. And it now has almost 8 billion human hosts worldwide, capable of disseminating it across borders in a way never seen for the plagues that ravaged communities before the 20th century. There have already been reports of sustained labor shortages in the USA and Britain, two of the hardest-hit countries, ensuing from the travails of millions of Americans and Britons battling the effects of long COVID or the serious illnesses to which COVID-19 predisposes us. If officials simply pursue a "let it rip" strategy for each new COVID variant, we'll be setting up US society for calamity in the months and years down the road as more and more millions of Americans tackle the ramifications of organ damage from the cumulative risk that builds with each infection. It's understandably troubling to have to fight such a tenacious enemy that keeps returning, again and again, with a new wave every few months. But this is effectively a war for which it is our generation's lot to fight; SARS-CoV-2 is a force of nature and will not subside for our convenience, and we ignore or dismiss it at our peril."

Dr. Mary Rodgers, the principal scientist at Abbott says, "I recommend following the guidance and recommendations made by government officials and healthcare experts in your area. If masks aren't required in your area, I recommend tracking cases in your area and if they're on the rise, consider wearing one when indoors and in crowded areas, especially if you are more vulnerable to COVID-19 or going around people who may be at a higher risk. It also comes down to each individual's comfort level; if mask wearing helps provide peace of mind, then I recommend using them."6254a4d1642c605c54bf1cab17d50f1e

Summer is here and we're tired of being isolated but Dr. Rodgers suggests avoiding, "Any crowded area where people aren't wearing masks, including concerts, grocery stores, etc. If cases are on the rise and mask mandates aren't instated in crowded areas, this could increase exposure and potential risk of contracting the virus. If found in this situation, I recommend taking proper precaution including getting vaccinated and boosted, wearing a mask, attempting to maintain a distance from others and testing before and/or after with rapid tests"including BinaxNOW Self Test by Abbott"to help prevent the spread."

Dr. Rodgers suggests staying away from, "bars and restaurants in areas with heightened cases. While some bars and restaurants do still have mask mandates, as soon as you're seated, you're able to remove your mask, allowing for potential spread. If going out to a bar or restaurant, I recommend dining outside as temperatures increase, avoiding times when it's more likely to be crowded, ensuring you're vaccinated and boosted and testing before and/or after with" self tests.

Who doesn't love a good buffet? While we might be tempted to enjoy a spread of gourmet cuisines, Dr. Syeda Amna Husain, a doctor who has partnered with Abbott doesn't recommend it. "People are touching their nose and mouth and then proceed to touch the spoons and containers in the buffet line, so there is always a possibility to transmit any kind of infection, not necessarily just COVID."

Follow the public health fundamentals and help end this pandemic, no matter where you liveget vaccinated or boosted ASAP; if you live in an area with low vaccination rates, wear an N95 face mask, don't travel, social distance, avoid large crowds, don't go indoors with people you're not sheltering with (especially in bars), practice good hand hygiene, and to protect your life and the lives of others, don't visit any of these 35 Places You're Most Likely to Catch COVID.

Wes Ulm, MD, PhD, is a physician-researcher, musician (J. Wes Ulm and Kant's Konundrum) ,and novelist, and earned a dual MD/PhD degree from Harvard Medical School and MIT. He is part of the Heroes of the COVID Crisis series in relation to his ongoing efforts in the drug discovery and public health arena.

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I'm a Virus Expert and I Warn You Not to Go Here Even if it's Open Eat This Not That - Eat This, Not That

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Borderline Schizophrenia: What It Is and More – PsychCentral.com

Its rare for borderline personality disorder (BPD) and schizophrenia to occur together, but it is possible.

Mental health conditions arent usually cut-and-dry conditions. Its common for some people to have multiple mental health conditions that might be connected, such as living with depression and anxiety, or post-traumatic stress disorder (PTSD) and substance use disorder (SUD).

The same is true for some people with schizophrenia and borderline personality disorder (BPD), which can occur together.

To understand what the co-occurring disorders of borderline personality disorder and schizophrenia might look like, it can be helpful to familiarize yourself with what each disorder looks like separately.

And despite the seriousness of each condition, managing symptoms is possible with the right treatment plan.

You wont find the term borderline schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM 5). It hasnt been a recognized disorder since 1980.

Borderline schizophrenia or pseudoneurotic schizophrenia is an outdated term once used interchangeably with borderline psychosis. Later on, this was split into the current classifications of schizotypal personality disorder and borderline personality disorder (BPD).

But there are some overlapping symptoms between BPD and schizophrenia.

It is possible for someone to have both disorders at the same time, though it is rare. But more research is still needed on the comorbidity of BPD and schizophrenia.

While 2014 research indicates that people with borderline personality disorder often experience co-occurring psychiatric conditions, the exact rate of schizophrenia and BPD comorbidity specifically isnt clear just yet.

A 2010 study found that 17.6% of people diagnosed with schizophrenia also met the criteria for BPD. But research from 2018 illustrated that schizophrenia was present in only 2% of females with BPD.

If you or a loved one has both BPD and schizophrenia, learning the similarities and differences of these conditions can be helpful in understanding how they may interact.

BPD is classified in the DSM 5 as a personality disorder, which is generally characterized by:

Research from 2008 found that up to 5.9% of people may experience BPD at some point in their lifetime. Onset typically occurs during adolescence or young adulthood.

Schizophrenia falls within the schizophrenia spectrum class of disorders in the DSM 5.

According to the National Institute of Mental Health (NIMH), schizophrenia affects less than 1% of the population, and is among the top 15 causes of disability worldwide, with symptoms indicating a diminished connection to reality.

Psychosis refers to a severe disconnection from reality. Psychotic episodes include hallucinations or delusions.

Psychosis can occur in both schizophrenia and borderline personality disorder, but psychotic episodes in BPD are, by definition, short, fleeting, and related to stress.

A significant but smaller percentage of people with BPD experience hallucinations than people with schizophrenia. According to research from 2021, an estimated 29% to 50% of people with BPD report hallucinations.

This is compared to an estimated 60% to 80% of people with schizophrenia who report experiencing these symptoms, based on a 2021 review.

And unlike schizophrenia, BPD psychotic episodes are generally not accompanied by negative symptoms or disorganization.

While its rare for BPD and schizophrenia to cooccur together, some symptoms may overlap.

Knowing the differences in how each conditions symptoms can look and feel can be helpful.

Schizophrenia symptoms generally fall under three categories:

Some of the most common symptoms of borderline personality disorder include:

A significant but smaller percentage of people with BPD may also experience:

If youre considering acting on suicidal thoughts, please seek professional support immediately.

Calling or texting a crisis helpline will connect you with a trained counselor 24/7, any day of the year, completely free of charge:

The causes of both BPD and schizophrenia arent entirely clear to experts at this time, and more research is needed. Its believed that genetics, physiology, and environment all play a role in the development of these conditions.

No single factor is likely to lead to the development of these disorders but rather a complex combination of multiple sources.

Though no single gene has been identified as a cause of BPD or schizophrenia, its clear that family history may play a role in their development.

A 2017 review of twin studies found that if an identical twin develops schizophrenia, the other may have a higher chance of developing it, too.

Family members of those with BPD also have a higher chance of developing the condition, according to research from 2021.

But this doesnt mean that having a family member with one of these conditions guarantees that you will develop it, too.

Experiencing trauma early in life can be a contributing factor to developing BPD.

A 2021 review indicates that up to 90% of people living with BPD experienced childhood trauma, including:

A different 2021 review suggests that environmental sources may account for between 15% to 40% of the chance of developing schizophrenia, but those sources are believed to be more diverse than those that contribute to BPD.

This may include:

Differences in neurotransmitter levels especially serotonin and dopamine may impact the development of both schizophrenia and BPD.

And, its not just your brain chemicals. Regions of the brain in charge of emotion regulation and impulse control including the amygdala and hippocampus may look and function differently in people with BPD.

Neuroimaging research from 2018 of people with schizophrenia showed significant differences in the size and activity of the frontal and temporal lobes, which play a large role in:

Both BPD and schizophrenia require professional treatment to manage. These conditions can be more difficult to address if you havent received an accurate diagnosis.

Working with a doctor or therapist on designing an effective treatment plan can help you manage symptoms.

Treatment plans for both conditions may consist of a combination of:

Finding the best treatment plan for your symptoms can take time. You may have to try multiple strategies before finding what works for you.

Psychotherapy is considered a first-line treatment for BPD and is often used to treat schizophrenia in combination with medication.

Specific types of therapy used for BPD include:

Though research on how well transference-focused therapy performs is mixed.

For those with schizophrenia, therapy may focus more heavily on developing skills for managing everyday life.

Types of therapy commonly used include:

Currently, there are no FDA-approved medications available to specifically treat BPD. But some people with BPD may have overlapping mental health conditions and may be prescribed medications for those conditions, such as:

For people with schizophrenia, antipsychotic medication is commonly prescribed to help manage hallucinations and delusions, including:

Stress can impact both BPD and schizophrenia, and lifestyle changes centered on self-care can be essential for managing symptoms of these conditions.

Some examples of self-care strategies include:

If you or someone you know is experiencing symptoms of BPD and schizophrenia, youre not alone. Its possible to manage the symptoms of these conditions with the right treatment plan.

Consider talking with your doctor or therapist as a first step. Being curious and educating yourself on what these two conditions can look like as well as possible treatment options can be a helpful place to start your mental health journey.

If youre ready to get help but dont know where to begin, you can check out Psych Centrals hub for finding mental health support.

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Borderline Schizophrenia: What It Is and More - PsychCentral.com

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The Origins of Our Blood May Not Be What We Thought – SciTechDaily

Clusters of the earliest hematopoietic cells being born in the walls of the umbilical artery of a mouse embryo. The cells colored in red represent embryonic multipotent progenitor cells (eMPPs). Credit: Sachin H. Patel/Boston Childrens Hospital

Barcoding studies discovered two independent sources for blood cells in mice. If confirmed in humans, our understanding of blood cancers, bone marrow transplants, and the aging immune system will change.

The origins of our blood may not be quite what we thought. Using cellular barcoding in mice, groundbreaking research finds that blood cells originate not from one type of mother cell, but two, with potential implications for blood cancers, bone marrow transplant, and immunology. Fernando Camargo, PhD, of the Stem Cell Program at Boston Childrens Hospital led the study, published in the journal Nature on June 15, 2022.

Historically, people have believed that most of our blood comes from a very small number of cells that eventually become blood stem cells, also known as hematopoietic stem cells, says Camargo, who is also a member of the Harvard Stem Cell Institute and a professor at Harvard University. We were surprised to find another group of progenitor cells that do not come from stem cells. They make most of the blood in fetal life until young adulthood, and then gradually start decreasing.

The researchers are now following up to see if the findings also apply to humans. If so, these cells, known as embryonic multipotent progenitor cells (eMPPs), could potentially inform new treatments for boosting aging peoples immune systems. They could also shed new light on blood cancers, especially those in children, and help make bone marrow transplants more effective.

Camargos team applied a barcoding technique they developed several years ago. Using either an enzyme known as transposase or CRISPR gene editing, they inserted unique genetic sequences into embryonic mouse cells in such a way that all the cells descended from them also carried those sequences. This enabled the team to track the emergence of all the different types of blood cells and where they came from, all the way to adulthood.

Previously, people didnt have these tools, says Camargo. Also, the idea that stem cells give rise to all the blood cells was so embedded in the field that no one attempted to question it. By tracking what happened in mice over time, we were able to see new biology.

Through barcoding, the researchers found that eMPPs, as compared with blood stem cells, are a more abundant source of most lymphoid cells important to the immune responses, such as B cells and T cells. Camargo believes the decrease in eMPPs that they observed with age may explain why peoples immunity weakens as they get older.

Were now trying to understand why these cells peter out in middle age, which could potentially allow us to manipulate them with the goal of rejuvenating the immune system, says Camargo.

In theory, there could be two approaches: extending the life of eMPP cells, perhaps through growth factors or immune signaling molecules, or treating blood stem cells with gene therapy or other approaches to make them more like eMPPs.

Camargo is also excited about the potential implications for better understanding and treating blood cancers. For example, myeloid leukemias, striking mostly older people, affect myeloid blood cells such as granulocytes and monocytes. Camargo thinks these leukemias may originate from blood stem cells, and that leukemias in children, which are mostly lymphoid leukemias, may originate from eMPPs.

We are following up to try to understand the consequences of mutations that lead to leukemia by looking at their effects in both blood stem cells and eMPPs in mice, he says. We want to see if the leukemias that arise from these different cells of origin are different lymphoid-like or myeloid-like.

Finally, the recognition that there are two types of mother cells in the blood could revolutionize bone marrow transplant.

When we tried to do bone marrow transplants in mice, we found that the eMPPs didnt engraft well; they only lasted a few weeks, says Camargo. If we could add a few genes to get eMPPs to engraft long term, they could potentially be a better source for a bone marrow transplant. They are more common in younger marrow donors than blood stem cells, and they are primed to produce lymphoid cells, which could lead to better reconstitution of the immune system and fewer infection complications after the graft.

Reference: Lifelong multilineage contribution by embryonic-born blood progenitors by Sachin H. Patel, Constantina Christodoulou, Caleb Weinreb, Qi Yu, Edroaldo Lummertz da Rocha, Brian J. Pepe-Mooney, Sarah Bowling, Li Li, Fernando G. Osorio, George Q. Daley and Fernando D. Camargo, 15 June 2022, Nature.DOI: 10.1038/s41586-022-04804-z

Sachin H. Patel, MD, PhD, of the Stem Cell Program (now at University of California San Francisco) and Constantina Christodoulou, PhD (now at Bristol Myers Squibb) were co-first authors on the paper. The study was funded by the National Institutes of Health (HL128850-01A1, P01HL13147), the Evans MDS Foundation, the Alex Lemonade Foundation, the Leukemia and Lymphoma Society, and the Howard Hughes Medical Institute. The authors declare no competing interests.

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The Origins of Our Blood May Not Be What We Thought - SciTechDaily

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Bone Marrow Aspirate Concentrates Market: Increasing Use in Orthopedic Surgery Applications to Drive Sales in the Global Market – BioSpace

Wilmington, Delaware, United States: The global bone marrow aspirate concentrates market was valued around US$ 130.0 Mn in 2016 is anticipated to register a stable CAGR of over 5.0% during forecast period of 2017 to 2025, according to a new report published by Transparency Market Research (TMR) titled Bone Marrow Aspirate Concentrates Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20172025. Growth of the global bone marrow aspirate concentrates market is driven by increased prevalence of and incidences of orthopedic diseases, and sports injuries, along with high growth of the cosmetic surgery industry and increasing applications of the BMAC products in the cosmetic and orthopedic surgeries. The bone marrow aspirate concentrates market in Asia Pacific is expanding with a high potential to grow registering a CAGR above 6.0% on the backdrop of unmet clinical needs, rising geriatric population, large patient pool, favorable government regulations, development in health care sector, and increased focus on research and developmental activities.

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Increase in incidences of Osteoarthritis on the backdrop of rising geriatric population to drive market growth

According to a collaborative survey conducted by the United Nations and the World Health Organization, 1.2 billion people in China are suffering from OA, of which more than 55% are aged 60 years or above. On the backdrop of such a huge patient base, there has been several developments in the field orthopedic surgery. Bone marrow-derived stem cell treatment is considered a promising and advanced therapy. It reduces the injury healing time in orthopedic diseases to five to six weeks from four to six months in case of surgery. Reduction in the healing time is a factor likely to propel the Bone Marrow Aspirate Concentrates market during the forecast period. However, pain associated with the treatment, lack of product approval, and preference for alternative treatments are negatively affecting the market growth. Moreover, high investments in R&D and clinical trials, slow approval processes entailing sunken costs, and marginal returns on investment (RoI) for stakeholders are primary concerns faced by manufacturer further hampering growth of the market.

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Rise in the Number of BMAC Assisted Procedures to Boost Growth of Bone Marrow Aspirate Concentrates Accessories Segment

The product type segment is fragmented into bone marrow aspirate concentrates systems and bone marrow aspirate concentrates accessories. The bone marrow aspirate concentrates accessories segment is anticipated to carry major share of the market on the backdrop of rise in number of BMAC assisted procedures. Cell therapies have been used extensively over the past decade for a variety of medical applications to restore cellular function and enhance quality of life. Owing to the differentiation property, stem cells are being used for repair and regeneration of bone. Moreover, increase in awareness about hygiene and risk of cross-contamination in developing countries such as Brazil, China and India are expected to increase the use of single-use Jamshidi needles for bone marrow stem cell procedures. This is likely to fuel the growth of the accessories segment in the near future.

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Orthopedic Surgery Application to Dominate the Global Bone Marrow Aspirate Concentrates Market

The application segment of global bone marrow aspirate concentrates market is divided into orthopedic surgery, wound healing, chronic pain, peripheral vascular disease, dermatology, and others applications. Of which, orthopedic surgery segment is anticipated to dominate the market owing to rising geriatric population, and surge in incidences of osteoarthritis around the globe. The dermatology segment is anticipated to expand at the highest CAGR of over 6.0% during forecast period of 2017 to 2025 owing to current boom in the industry, increase in disposable income, and technological advancements in the market. The utilization of the regenerative ability of fibroblasts and keratinocytes from human skin has formed new ways to develop cell-based therapies for patients. Moreover, capacity of bone marrow derived extra-cutaneous cells is being researched for its plasticity in regenerating skin; it is likely to lead to the future growth of cell therapies in dermatology.

Rise in Healthcare Expenditure to Fuel Growth of Hospitals & Clinics End-user Segment

In terms of end-users, market is divided into hospitals & clinics, pharmaceutical & biotechnology companies, Contract Research Organizations (CROs) & Contract Manufacturing Organizations (CMOs), and academic & research institutes. The hospitals & clinics segment dominated the bone marrow aspirate concentrates market in 2016. The trend is expected to continue during the forecast period. The hospitals & clinics segment is likely to be followed by the biotechnology & biopharmaceutical companies segment in terms of market share during the forecast period. The segment is anticipated to hold more than 8.0% of market share in 2016. Growth of the segment is attributed to increasing number of biotechnology companies and rising partnerships among the market players to expand global presence.

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Large Patient Pool in Developing Countries Like China, India, Brazil, and Taiwan to Create More Opportunities in the Market

Geographically, global bone marrow aspirate concentrates market is divided into major five geographical regions, including North America, Europe, Asia-Pacific, Latin America and Middle East and Africa. North America is anticipated to hold major share of the market owing to technological advancements and regulatory approval for new devices, awareness about stem cell therapy, and rise in number of cosmetic surgical procedures. While, Asia Pacific orthopedic market is at a pivotal point today, which was valued around US$ 19 Million in 2016 and anticipated to derive massive and augmented growth. The orthopedic market in Asia, including bone graft, spine, and bone substitute, is anticipated to grow more than twice as fast as the overall orthopedic market which will further boost growth of BMAC market in the region.

Semi-consolidated Market with 3-4 key Players Operating in the BMAC Systems Market Segment

Key players covered in this report are Terumo Corporation (Terumo BCT), Ranfac Corp., Arthrex, Inc., Globus Medical, Inc., Cesca Therapeutics Inc., MK Alliance Inc. (TotipotentSC), and Zimmer Biomet Holdings, Inc. Companies operating in the global market for bone marrow aspirate concentrates are focusing on in-licensing and collaboration agreements to put new products in the developing markets like Asia Pacific, and Latin America. For instance, in August 2017, Cesca Therapeutics Inc. announced a distribution agreement with Boyalife WSN Ltd., a China based company. Through this agreement, Boyalife WSN Ltd. will distribute Cescas innovative biobanking and point-of-care solutions in China, India, Singapore, and the Philippines. As India and China represent two of the fastest growing economies in the world, successful penetration of these regions can generate more market opportunity to the companies.

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Bone Marrow Aspirate Concentrates Market: Increasing Use in Orthopedic Surgery Applications to Drive Sales in the Global Market - BioSpace

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What you need to know about Non-Hodgin’s Lymphoma – NewsPatrolling

Non-Hodgkins Lymphoma, also known as NHL, is a cancer that starts in the white blood cells in the lymphatic system. White blood cells are responsible for shielding the body from germs and is critical to the immune system. When cancer cells start multiplying in these lymphocytes, the tumours can spread throughout the body, eventually attacking every organ.

NHL is a broader term used to define the various lymphomas affecting the lymphatic system, including the lymph nodes and lymph tissue. Lymphoma can begin anywhere in the body, wherever the lymphatic tissue is found and is mainly seen in adults. Lymph nodes, spleen, adenoids, tonsils, bone marrow, thymus, and digestive tract are where the Lymphoma can start before affecting the entire system.

Classification of Lymphomas

There are several types of Non-Hodgkins Lymphoma, and while classifying a Lymphoma, the doctors consider a few points. Lymphomas can be categorized based on:

The type of lymphocyte the Lymphoma emerged from.

Structure of Lymphoma under the microscope.

The features of chromosomes in the lymphoma cell, and

Presence of specific proteins on the surface of the cancer cells.

Types of Lymphomas

The types of lymphomas are distinguished based on the type of the lymphocytes affected. There are two basic types of lymphocytes The T-cells and the B-cells. T cells protect us from infection and the B cells create antibodies to neutralize the infection- causing germs.

The types of lymphoma include:

The Chronic Lymphocytic Leukemia or CLL is cancer of the blood and bone marrow, and it generally progresses slower when compared to other types of leukemia. In this type of cancer, the white blood cells get affected and are often seen in older adults. Chronic lymphocytic leukemia doesnt present with any symptoms at the initial stages, but swollen lymph nodes, coupled with fatigue, fever, and unintended weight loss are some common signs.

Closely related to the CLL is Small Lymphocytic Lymphoma, or SLL, found in the lymph nodes and the spleen.

A rare type of cancer, Cutaneous B-cell Lymphoma, begins in white blood cells, specifically in one kind of germ-fighting lymphocyte called B cells or B lymphocytes. This cancer presents itself as a thick bump, the same as ones skin color or pink or purple, and is located under the skin.

Also known as CTCL, the Cutaneous T cell Lymphoma begins in the white blood cells but in T lymphocytes, attacking the skin. CTCL often presents with rash, redness on the skin, scaly patches, and small tumours under the skin.

Follicular Lymphoma is a sluggish or a slow-growing type of cancer and is often found in people aged above 60. These cancers occur either in lymph nodes or in the bone marrow. If not treated on time, follicular lymphomas can grow fast, diffusing large B-cells.

Causes of Non-Hodgkins Lymphoma

It is tough to pinpoint a single causative factor for Non-Hodgkins Lymphoma. This cancer begins either in B cells or T cells in the lymphatic system.

Most Common Risk Factors

Patients on immunosuppressive medications administered after an organ transplant are at high risk of developing Non-Hodgkins Lymphoma.

Patients with a history of certain viruses and bacterial infections, including HIV, Epstein-Barr, and Helicobacter pylori, are prone to this type of cancer.

Overexposure to certain chemical compounds in pesticides used for killing insects may up the risk of Lymphoma.

Though Non-Hodgkins Lymphoma can happen at any age, it is often diagnosed in people above 60 years of age.

Diagnosis

Non-Hodgkins Lymphoma is diagnosed through blood tests and imaging tests like CT, MRI and PET-CT. Minimally invasive diagnostic procedures like lymph node tests, bone marrow tests, and lumbar puncture are also done for collecting samples and reviewing them in labs for accurate diagnosis.

Treating Non-Hodgkins Lymphoma

Chemotherapy:

Chemotherapy is the first line of treatment for this type of cancer. It is often administered as a part of a bone marrow transplant where high dosage of chemotherapy kills cancer cells and act as a precursor to the transplant.

Radiation Therapy

Radiation therapy which involves high-powered energy beams being used to target cancer cells is recommended in the case of indolent NHL. It is used subsequently in chemotherapy, often aimed at the affected lymph nodes to curtail its progression.

Targeted Drug Therapy

Targeted drug therapy uses certain medications that block abnormalities in the cancer cells and make them die and is often combined with chemotherapy.

Bone Marrow Transplant

Also known as stem cell transplant, a bone marrow transplant is done by infusing healthy bone marrow stem cells from a donor into the patients body. These bone marrow cells aid in rebuilding bone marrow and are prescribed if other treatments fail to give the desired outcome.

Immunotherapy

Immunotherapy is recommended in the specific type of NHL where proteins produced by the cancer cells hide from the immune system. Immunotherapy disrupts the job of these proteins and makes the immune system fight the malignant cells. The treatment methods in combating Non-Hodgkins Lymphoma have come a long way in the recent decade.

It is advisable to consult a healthcare expert immediately in case of any of the symptoms.

BY: Dr. Prasad Gunari, Senior Consultant Medical Oncology, HCG NMR Cancer Centre, Hubli.

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What you need to know about Non-Hodgin's Lymphoma - NewsPatrolling

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Expert Cancer Homoeo Clinic Helping Patients with Aplastic Anaemia through Homoeopathic Treatment – Digital Journal

Expert Cancer Homoeo Clinic is delivering impactful homoeopathic treatment in the country for various diseases and disorders that include aplastic anaemia caused by a bone marrow injury.

Expert Cancer Homoeo Clinic was established in 1979 by Dr. Devendra Singh to cure chronic and dreaded diseases like neck cancer, gastrointestinal cancer, blood cancer and prostate cancer by homoeopathy. This chain of homoeopathic clinics has now expanded to possess many experienced physicians who are consistently ranked as the top cancer doctors in the world and who are trained in prestigious medical schools and research centres. Expert Cancer Homoeo Clinic offers advanced oncology care in a humane environment to its patients.

During a press interview organized recently, the spokesperson of Expert Cancer Homoeo Clinic shared, Our homoeopathic treatment is now also available for the rare disease of aplastic anaemia, in which the bone marrow and its hematopoietic stem cells get damaged. This causes a deficiency of all three blood cell types red blood cells, white blood cells, and platelets. Aplastic means the inability of stem cells to generate mature blood cells. Our homoeopathic medicines have proven to be quite effective on this type of disease.

Expert Cancer Homoeo Clinic has the top homoeopathic doctor in Indiato deliver the right treatment according to the factors that may have caused aplastic anaemia. Generally, the factors that can temporarily or permanently injure the bone marrow and affect the blood cell production include radiation and chemotherapy treatments, exposure to toxic chemicals, use of certain drugs, autoimmune disorders, a viral infection, and pregnancy with an autoimmune problem. There are also unknown factors leading to idiopathic aplastic anaemia disease.

The spokesperson additionally stated, Aplastic anaemia can progress slowly over weeks or months, or it may come on suddenly. The illness may be brief, or it may become chronic. Aplastic anaemia can be very severe and even fatal. Thus, it is always advisable to meet a doctor for timely treatment, if the patient notices the symptoms. Some of its symptoms are shortness of breath with exertion, fatigue, rapid or irregular heart rate, pale skin, unexplained or easy bruising, frequent or prolonged infections, nosebleed, dizziness, and skin rashes.

Expert Cancer Homoeo Clinic suggests the aplastic anaemia treatment in homoeopathythat can stimulate the healthy portion of bone marrow to improve cell production. This may help to reduce the number of blood transfusions. Homoeopathy medicines improve the patients general vitality and well-being and help them to fight infections. These medicines control the bleeding disorder associated with aplastic anaemia. The clinic gives the medicinal treatment that is beneficial in countering the side effects associated with conventional therapy. The chances of relapse also significantly diminish with the homoeopathic treatment of aplastic anaemia.

About Expert Cancer Homoeo Clinic:

Expert Cancer Homoeo Clinic is a chain of homoeopathy clinics in India. The clinic offers treatment for several dreaded diseases, ranging from all types of cancer to kidney diseases. Whether the patients require effective migraine treatment in Delhi or need to schedule an appointment with the best cancer doctor in Mumbai, they can do it all with the Expert Cancer Homoeo Clinic. The clinic follows a holistic treatment approach, ensuring complete healing.

Contact Information:

Expert Cancer Homoeo Clinic

Address Lucknow Centre: Opposite Picadilly Hotel, Kanpur-Lucknow Road, Bara Birwa, Jafar Khera, Alambagh, Lucknow, Uttar Pradesh, India

Phone (Mb): +91-9616385385 (Lucknow)

Address Delhi Centre: 101, Ashish Complex, Opposite Cafe Coffee Day, Near Alchon Public School, Mayur Vihar Phase 1, New Delhi, India

Phone: +91-9560062231 (Delhi)

Address Mumbai Centre: 504 Sunshine, Opp. Shastri Nagar, Lokhandwala, Andheri West, Mumbai, India

Phone: +91-8176813454 (Mumbai)

Email: [emailprotected] (Delhi) / [emailprotected] (Mumbai) / [emailprotected](Lucknow)

Website: http://cancerhomoeoclinic.co.in/

Media ContactCompany Name: Expert Cancer Homoeo ClinicContact Person: Dr. Devendra Singh Email: Send EmailPhone: +91-8176813454Address:504 Sunshine, Opp Shastri Nagar, Lokhandwala, Andheri West City: MumbaiState: MaharashtraCountry: IndiaWebsite: cancerhomoeoclinic.co.in

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Expert Cancer Homoeo Clinic Helping Patients with Aplastic Anaemia through Homoeopathic Treatment - Digital Journal

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Experts offer hope to vitiligo patients – The New Indian Express

Express News Service

BENGALURU: Vitiligo, a skin de-pigmentation disorder which affects 0.1 to 8% of population, is a cause of worry especially for women as it mainly affects face, neck and hands. It relapses in 40% of patients, within a year after stopping treatment. But Mesenchymal stem cell-based therapy can be a hope, experts say.

On World Vitiligo Day on Saturday, dermatologist, Aster R V Hospital, Dr Sunil Prabhu said the disorder is affecting at least 2.16% of children/adolescents. Vitiligo is a long-term condition, where pale white patches develop on the skin due to lack of melanin pigment. According to Dr Praveen Bharadwaj, dermatology consultant, Manipal Hospital, Whitefield, vitiligo is a condition in which the patients immune system weakens which affects the normal functioning of melanin producing cells.

Dr Bharadwaj explained, Mesenchymal stem cells, which are multi-potent adult stem cells, are found in bone marrow, fat tissues, umbilical cord and human foreskin. They are promising agents for therapy for the re-pigmentation of skin in vitiligo. This therapy reduces the main trigger of vitiligo that is immune-mediated melanocyte degeneration (stopping the immune destruction of melanocytes which produces melanin), promotes melanocytes and prevents relapse of the condition, he said.

Link:
Experts offer hope to vitiligo patients - The New Indian Express

Recommendation and review posted by Bethany Smith

Jasper Therapeutics to Participate in the William Blair 42nd Annual Growth Stock Conference – GuruFocus.com

REDWOOD CITY, Calif., June 07, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. ( JSPR), a biotechnology company focused on enabling cures with stem cell therapies, today announced that the Company is participating in the William Blair 42nd Annual Growth Stock Conference, to be held in Chicago from June 6-9, 2022.

Ronald Martell, Jaspers Chief Executive Officer, is scheduled to present on Thursday, June 9th at 8:00AM CT, with a breakout session to follow at 8:40AM CT. A live webcast of the presentation will be available at https://wsw.com/webcast/blair66/jasp/1933236 and at the Companys Investor Events webpage.

About Jasper TherapeuticsJasper Therapeutics, Inc. is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective, and potentially curative, allogeneic hematopoietic cell transplants and gene therapies. A clinical study of JSP191 as a novel, disease-modifying, therapeutic for patients with lower risk MDS is also planned to begin in 2022. In parallel, Jasper Therapeutics, Inc. is advancing its preclinical mRNA hematopoietic stem cell grafts platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

Forward-Looking StatementsCertain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential of the Companys JSP191 and mRNA engineered stem cell graft programs. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jaspers product candidates; the risk that prior study results may not be replicated; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that Jaspers product candidates may not be beneficial to patients or successfully commercialized; patients willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jaspers business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jaspers business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jaspers filings with the SEC. If any of these risks materialize or Jaspers assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jaspers assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:

John Mullaly (investors)LifeSci Advisors617-429-3548[emailprotected]

Jeet Mahal (investors)Jasper Therapeutics650-549-1403[emailprotected]

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Jasper Therapeutics to Participate in the William Blair 42nd Annual Growth Stock Conference - GuruFocus.com

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What New Advances are there in 3D Bioprinting Tissues? – AZoM

A paper recently published in the journal Biomaterials reviewed the new advances in three-dimensional bioprinting (3DBP) for regenerative therapy in different organ systems.

Study:Advances in 3D bioprinting of tissues/organs for regenerative medicine and in-vitro models. Image Credit:luchschenF/Shutterstock.com

Organ/tissue shortage has emerged as a significant challenge in the medical field due to patient immune rejections and donor scarcity. Moreover, mimicking or predicting the human disease condition in the animal models is difficult during preclinical trials owing to the differences in the disease phenotype between animals and humans.

3DBP has gained significant attention as a highly-efficient multidisciplinary technology to fabricate 3D biological tissue with complex composition and architecture. This technology allows precise assembly and deposition of biomaterials with donor/patients cells, leading to the successful fabrication of organ/tissue-like structures, preclinical implants, and in vitro models.

In this study, researchers reviewed the 3DBP strategies currently used for regenerative therapy in eight organ systems, including urinary, respiratory, gastrointestinal, exocrine and endocrine, integumentary, skeletal, cardiovascular, and nervous systems. Researchers also focused on the application of 3DBP to fabricate in vitro models. The concept of in situ 3DBP was discussed.

In this extensively used low-cost bioprinting method, rotating screw gear or pressurized air is used without or with temperature to extrude a continuous stream of thermoplastic or semisolid material. Different materials can be printed at a high fabrication speed using this technology. However, low cell viability and the need for post-processing are the major drawbacks of extrusion bioprinting.

In this method, liquid drops are ejected on a substrate by acoustic or thermal forces. High fabrication speed, small droplet volume, and interconnected micro-porosity gradient in the fabricated 3D structures are the main advantages of this technique. However, limited printed materials and clogging are the biggest drawbacks of inkjet bioprinting.

A laser is used to induce the forward transfer of biomaterials on a solid surface in the laser-assisted bioprinting method. High cell viability and nozzle-free noncontact process are the biggest advantages of laser-assisted bioprinting, while metallic particle contamination and the time-consuming nature of the printing process are the major disadvantages.

Several studies were performed involving the development of neuronal tissues using the 3DBP method. The pressure extrusion/syringe extrusion (PE/SE) bioprinting technique was used for central nervous tissue (CNS) tissue replacement. The layered porous structure was fabricated using glial cells derived using human induced pluripotent stem cell (iPSC) and a novel bioink based on agarose, alginate, and carboxymethyl chitosan (CMC) formed synaptic networks and displayed a bicuculline-induced enhanced calcium response.

Similarly, stereolithography (SLA) was used to fabricate a 3D scaffold for CNS and the viability of the scaffold was evaluated for regenerative medicine application. Layered linear microchannels were printed using poly(ethylene glycol) diacrylate-gelatin methacrylate (PEGDA-GelMA) and rat E14 neural progenitor cells (NPCs). The 3D scaffold restored the synaptic contacts and significantly improved the functional outcomes. Cyclohexane was used to bond polystyrene fibers to matrix bundle terminals during crosslinking.

Multiphoton excited 3-dimensional printing (MPE-3DP) was employed for the regeneration of myocardial tissue. A layer-by-layer structure was fabricated using GelMA/ sodium 4-[2-(4-morpholino)benzoyl-2-dimethylamino]-butylbenzenesulfonate (MBS) and human hciPSC-derived cardiomyocytes (CMs), endothelial cells (ECs), and smooth muscle cells (SMCs). The crosslinking was performed by photoactivation. The structure promoted electromechanical coupling and improved cell proliferation, vascularity, and cardiac function.

Fused deposition modeling (FDM) and PE/SE bioprinting method were used for complex tissue and organ regeneration. A micro-fluid network heart shape structure was fabricated using polyvinyl alcohol (PVA), agarose, sodium alginate, and platelet-rich plasma and rat H9c2 cells and human umbilical vein endothelial cells (HUVECs). 2% calcium dichloride was used during the crosslinking mechanism. The fabricated structure possessed a valentine heart with hollow mechanical properties and a self-defined height.

SE printing was utilized to fabricate a capillary-like network using collagen type1/ xanthan gum and human fibroblasts and ECs for applications in blood vessels. The fabricated network possessed endothelial networks and sprouting between the fibroblast layers.

Bone, cartilage, and skeletal muscle tissue can be repaired and regenerated using the 3DBP technique. For instance, FDM printing was used to print multifunctional therapeutic scaffolds for the treatment of bone. Filopodial projections were fabricated using polylactic acid (PLA) platform loaded with hyaluronic acid (HA)/ iron oxide nanoparticles (IONS)/ minocycline and human MG-63 and human bone marrow stromal cells (hBMSCs), which improved the osteogenic stimulation of the IONS and HA.

PE/SE method was used to fabricate disks and cuboid-shaped scaffolds using - tricalcium phosphate (TCP) microgel and human fetal osteoblast (hFOB) and bone marrow-derived mesenchymal stem cell (BM-MSC) for bone repair, multicellular delivery, and disease model. The fabricated structures promoted osteogenesis.

PE/SE bioprinting was also utilized to fabricate complex porous layered cartilage-like structures using alginate/gelatin/HA, rat bone marrow mesenchymal stem cells (BMSCs), and cow cardiac progenitor cells (CPCs) for hyaline cartilage regeneration. The CPCs upregulated gene expression of proteoglycan 4 (PRG4), SRY-box transcription factor 9 (SOX9), and collagen II.

PE/SE printing was also used to fabricate multinucleated, highly-aligned myotube structures using polyurethane (PU), poly(-caprolactone) (PCL), and mouse C2C12 myoblasts and NIH/3T3 fibroblasts for in-situ expansion and differentiation of skeletal muscle tendon. The fabricated constructs demonstrated more than 80% cell viability with initial tissue differentiation and development.

SLA bioprinting technique was used to fabricate bi-layered epidermis-like structure using collagen type I, mouse NIH 3T3 fibroblast cells, and human keratinocyte cells for tissue model and engineering. The fabricated constructs effectively imitated the tissue functions.

Similarly, PE was employed to fabricate microporous structures using human amniotic mesenchymal stem cells (AFSCs) and heparin-HA-PEGDA for wound healing. The construct improved the wound closure and reepithelialization, increased extracellular matrix synthesis and vascularization, and prolonged the cell paracrine activity.

PE technique was utilized to prepare a multilayered cornea-like structure using human keratocytes and methacrylated collagen (ColMA)-alginate. The cell viability of the keratocytes decreased from 90% to 83% after printing.

PE/SE bioprinting was utilized to bioprint multilayered liver-like structures using GeIMA and human HepG2/C3A for liver tissue engineering. Similarly, hepatocytes were also bioprinted to fabricate multiple organ precursors with branching vasculature. A small intestine model with improved intestinal function and high cell proliferation was fabricated using caco-2 cell-loaded polyethylene vinyl acetate (PEVA) scaffold.

Spheroids of mesenchymal stem cells (MSCs) and chondrocytes and lung endothelial cells were utilized to fabricate scaffold-free tracheal transplant. After implantation in the rat model, the matured spheroids displayed excellent vasculogenesis, chondrogenesis, and mechanical strength. FDM technique was used to fabricate a glomerular structure for kidneys using human iPSCs and hydrogel and a hollow porous network using poly(lactic-co-glycolic acid (PLGA)/PCL/tumor-associated endothelial cells (TECs) for the urethra.

In in-situ bioprinting, the tissue is directly printed on the specific defect or wound site in the body for regenerative and reparative therapy. This method provides a well-defined structure and reduces the gap between host-implant interfaces. In-situ bioprinting is better than in vitro bioprinting techniques as the patients body, as a natural bioreactor, provides a natural microenvironment.

Several studies have evaluated this technique for tissue regeneration. For instance, PE/SE method was used for skin tissue regeneration in pigs and mice using fibrin/collagen/HA and human fibroblast cells. Skin-laden sheets of consistent composition, thickness, and width were formed upon rapid crosslinking of biomaterial. PE/SE technique was also used for neural tissue regeneration in mice using agarose/CMC/alginate and human iPSCs.

In vitro models provide significant assistance in understanding the mechanism of therapeutics and disease pathophysiology. Recently, in vitro models of human tissues and organs were engineered using 3DBP technology for safety assessment and drug testing.

In the 3DBP of organs and tissues, biomaterials play a crucial role in maintaining cellular viability, providing support, and long-term acceptance. Specifically, bioinks must possess unique properties, such as cell growth promotion and structural stability, that can be optimized for clinical use. Additionally, bioinks must be compatible with printers for high-precision rapid prototyping.

Bioinks fulfilling all of these requirements are yet to be identified. Moreover, managing the time during the bioprinting of the constructs is another major challenge, as the time required to fabricate them is often more than the survival time of cells. A bioreactor platform that supports organoid growth and provides time for tissue remodeling can be used to overcome this challenge. Ethical challenges and issues are also a hurdle since fabricating internal tissues/organs can lead to liability and biosafety concerns.

In the future, 3DBP can provide novel solutions to engineer organs/tissues and revolutionize modern healthcare and medicine if these challenges can be addressed.

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Jain, P., Kathuria, H., Dubey, N. Advances in 3D bioprinting of tissues/organs for regenerative medicine and in-vitro models. Biomaterials 2022. https://www.sciencedirect.com/science/article/abs/pii/S0142961222002794?via%3Dihub

Disclaimer: The views expressed here are those of the author expressed in their private capacity and do not necessarily represent the views of AZoM.com Limited T/A AZoNetwork the owner and operator of this website. This disclaimer forms part of the Terms and conditions of use of this website.

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CRISPR in the Classroom – The New York Times

A decade after CRISPR started to become a major tool in genetic research, a new generation of scientists is growing up with the technology. Even high school students are able to run CRISPR experiments. Some specialized public high schools teach CRISPR as a hands-on lesson in biotechnology. These classes cover everything from molecular biology to pipetting to biomedical ethics and career options.

Visualizing and comprehending whats happening on the molecular level is usually always the challenge, said Katy Gazda, a high school biotechnology teacher who taught CRISPR in her classroom last year. To help students better understand complex molecular movements, teachers use tools like paper models, 3-D printed models and online animations.

Note: Diagram is simplified.

1. Target the right gene

Scientists engineer a piece of RNA that is a match for the DNA they want to edit. This is called the guide RNA. Students can practice designing their own guide RNA sequences using the same free bioinformatics search tool that scientists use for research.

2. Bind the target

An enzyme called Cas9 binds to a piece of DNA and temporarily unwinds a section of the DNA. Students can model the process with paper cutouts, pushing a paper DNA sequence along a printed guide RNA until they match.

3. Cut the DNA

If the guide RNA matches a section of the DNA, the Cas9 enzyme cuts both strands of the DNA double helix. An interactive animation from the Howard Hughes Medical Institute shows students how the Cas9 enzyme changes its shape and snips through the DNA.

Repaired DNA with edited section

DNA fragments cut by Cas9

DNA fragments cut by Cas9

Repaired DNA with edited section

Note: Diagrams are simplified.

4. Repair and edit the DNA

Machinery inside the cell rushes to fix the broken DNA. One repair process uses a similar-looking, unbroken piece of DNA as a template to stitch the broken pieces back together.

Scientists can introduce tailor-made DNA into the cell tricking the repair machinery into using the engineered DNA as the template for stitching together the broken pieces.

Students also learn about real-life examples of DNA editing, such as therapies for genetic illnesses including sickle cell disease and cystic fibrosis. In some exercises, they can see examples of the actual DNA sequence associated with each illness and evaluate specific gene edits proposed to cure the illness.

Ms. Gazda believes that hands-on lab lessons help students open their minds to the idea that they can truly be a scientist. Several companies sell CRISPR curriculum kits to high schools and universities. One kit from Bio-Rad, a life science technology manufacturer, includes a prepackaged experiment using E. coli bacteria.

Bacteria Altered With CRISPR

E. coli

bacteria colonies

Petri

dishes full of

bacteria food

Petri

dish full of

bacteria food

Bacteria Altered With CRISPR

Petri

dish full of

bacteria food

A gene in the bacteria encodes an enzyme, called -gal, which can help break down certain molecules.

A bright blue color appears when X-gal is broken down by -gal.

A gene in the bacteria encodes an enzyme, called -gal, which can help break down certain molecules.

A bright blue color

appears when X-gal is

broken down by -gal.

Note: Diagrams and molecule names are simplified.

The E. coli bacteria used in the Bio-Rad kit are grown on a food mixture that includes a compound called X-gal. Normally, these bacteria are able to use an enzyme to break down the compound into two parts: a sugar molecule and an indicator molecule.

The indicator molecule turns deep blue, showing students that the bacterial enzyme is working. This colorful display is an important part of the experiment. It shows students what to expect in an unaltered, or control group a vital part of any scientific experiment.

The -gal enzyme is not produced.

The X-gal compound cannot be broken down without the -gal enzyme, so the bright blue indicator molecule is never produced.

After the students use CRISPR to transform a section of the gene, the gene is no longer functional.

After the students use CRISPR to transform a section of the gene, the gene is no longer functional.

The -gal enzyme is not produced. The X-gal compound cannot be broken down without the -gal enzyme, so the bright blue indicator molecule is never produced.

Note: Diagrams and molecule names are simplified.

The process of altering E. coli DNA with CRISPR involves lab techniques like pipetting liquids and carefully moving bacteria colonies. Teaching a new lab class like CRISPR can be intimidating, says Gregory Jubulis, a high school science teacher who uses the Bio-Rad kit in his biotechnology class. It takes you a few years before youre real comfortable with teaching something, he said.

But when classroom CRISPR lab kits first became available, he knew he wanted to teach it. I just want my kids to be ready for the future of science, he said.

Ms. Gazda uses lab classes as an opportunity to share career options with students. In a CRISPR lab, students may learn about careers in anything from molecular and cellular biology to entrepreneurship and science journalism.

Ethics always comes up, says Mr. Jubulis, explaining how he relates the lab experiment to real-life CRISPR applications like gene therapy. Many of his students have friends or family with genetic illnesses, so the topic can be deeply personal.

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CRISPR in the Classroom - The New York Times

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UNE researcher awarded $1.8 million to study chronic pain relief through gene therapy – University of New England

Chronic pain affects millions of people worldwide, yet popular treatments for pain including surgery and opioid medications can have disastrous side effects of their own. But with $1.8 million in funding from the National Institute of Neurological Disorders and Stroke (NINDS), a University of New England researcher will explore non-opioid treatments for chronic pain at the cellular level.

Benjamin Harrison, B.Sc., Ph.D., assistant professor of biochemistry and nutrition, will use the five-year R01 grant from the National Institutes of Health to study how to reduce the excitability of nociceptors, which are neurons that transmit pain signals in response to painful injuries.

Harrison and his team have discovered that nociceptors contain a protein called "CELF4, an RNA binding protein they theorize inhibits the production of pro-nociceptive, or pro-pain-sensing, cellular components. Harrisons research will focus on delivering CELF4 into pain neurons, where this protein will limit the synthesis of ion-channels, receptors, and other molecules that sensitize them.

Specifically, the researchers will study if a locally administered adeno-associated virus can stimulate production of CELF4 and reduce pain in those areas an approach known as gene vector therapy.

Harrison remarked that the innovative approach could prove beneficial for those living with chronic pain but who do not want to undergo surgeries which can be expensive and leave people with no sensation at all or use powerful pain-reducing medications like addictive opioids.

There are some chronic pain conditions that are simply intolerable, and people with those conditions are willing to do severe surgeries to reduce their pain, Harrison remarked. Using this novel gene therapy vector approach, we can develop pain therapies that are less invasive than surgery and carry fewer risks than conventional opioid medications.

Future directions for the research could include partnerships with clinicians for clinical trials, Harrison said.

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UNE researcher awarded $1.8 million to study chronic pain relief through gene therapy - University of New England

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Gene and Cell Therapy (GCT) Market Report (COVID-19 Analysis) by Worldwide Market Trends & Opportunities and Forecast to 2030 Designer Women -…

The Global Gene and Cell Therapy (GCT) Market is estimated at USD 2504.2 Million in the year 2020. Growth in the historic period in the cell and gene therapy market resulted from increase in investments in cell and gene therapies, growth in research and development, advances in cancer drug discovery, rise in public-private partnerships, strong economic growth in emerging markets, increased healthcare expenditure, and rising in pharmaceutical R&D expenditure.

Companies in the gene and cell therapy for oncology market are increasing their product innovation through strategic collaborations. To sustain in the increasingly competitive market, organizations are developing innovative products as well as sharing skills and expertise with other such enterprises. While oncology drug companies have long collaborated with each other as well as with academic and research institutions in this market by way of partnerships, in or out licensing deals, this trend has been increasing over the recent years.

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Further, the market was restrained by inadequate reimbursements, challenges due to regulatory changes, low healthcare access, and limited number of treatment centers. Going forward, increasing prevalence of cancer and chronic diseases, rising geriatric population, rising focus on cell and gene therapy, and rise in healthcare expenditure will drive the growth in the gene and cell therapy market. Factors that could hinder the growth of the market in the future include high costs of therapy, stringent regulations, reimbursement challenges, and coronavirus pandemic.

Scope of the Report

The report presents the analysis of Gene and Cell Therapy market for the historical period 2016-2020 and forecast period of 2021-2026.The report analyses the Gene and Cell Therapy Market by value (USD Million).The report analyses the Gene and Cell Therapy Market by Vector (Lentivirus, AAV, Retrovirus & Gammaretrovirus and Others).The report analyses the Gene and Cell Therapy Market Application (Oncology, Neurological disorders, cardiovascular disorders, Others).The Global Gene and Cell Therapy Market has been analysed By Region (North America, Europe, Asia Pacific, LAMEA), By Country (United States, Canada, Germany, U.K, France, Italy, China, Japan, India and South Korea).The key insights of the report have been presented through the frameworks of the attractiveness of the market has been presented by region, by Vector, By Application.

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Also, the major opportunities, trends, drivers and challenges of the industry has been analysed in the report.The report tracks competitive developments, strategies, mergers and acquisitions and new product development. The companies analysed in the report include F. Hoffman-La Roche Ltd., Novartis, Sanofi, Alnylam Pharmaceuticals Inc., Pfizer, BlueBird Inc., Sarepta Therapeutics, Voyager Therapeutics, Orchard Therapeutics Plc, AnGes Inc.

Key Target AudienceBiotechnology CompaniesPharmaceutical and Health CompaniesConsulting and Advisory FirmsGovernment and Policy MakersRegulatory Authorities

Table of Content:

Key Questions Answered in the Market Report

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SwanBio Presents Design of Innovative Natural History Study Aimed to Evolve Understanding of Adrenomyeloneuropathy and Inform Future Treatments -…

PHILADELPHIA--(BUSINESS WIRE)-- SwanBio Therapeutics, a gene therapy company advancing AAV-based therapies for the treatment of devastating, inherited neurological conditions, today presented details about the companys ongoing natural history study of adrenomyeloneuropathy (AMN) at the 8th Congress of the European Academy of Neurology (EAN) in Vienna. The intention of the CYGNET study is to assess disease progression in patients with AMN to inform the research and development of potential treatments, including SwanBios lead candidate, SBT101, the first clinical-stage AAV-based gene therapy for AMN.

At SwanBio, our approach to drug development begins with deepening our understanding of the origin and trajectory of diseases like AMN, ideally enabling us to deliver gene therapies that are both highly effective and meaningful for the quality of life of patients. With this in mind, our proprietary CYGNET study was designed to better characterize AMN disease progression, which varies from person to person, said Steven Zelenkofske, D.O., chief medical officer, SwanBio Therapeutics. CYGNET is the first AMN clinical study to feature wearables, which may help us identify sensitive outcomes related to clinically relevant changes early in men with AMN.

SwanBios CYGNET natural history study will track a number of variables over a two-year period, including:

More details about the CYGNET study, including demographics and disease characteristics of the first 21 patients enrolled, were presented during a virtual poster session at EAN.

SwanBio anticipates recruiting approximately 80 patients for the CYGNET natural history study; as of early June, the study was over 40% enrolled across five different global sites. Clinicians or patients interested in learning more about this study can review SwanBios CYGNET flyer or contact SwanBio at clinicaltrials@swanbiotx.com.

Presentation Details ePoster EPO-599: CYGNET: A prospective multicenter observational study of disease progression in patients with adrenomyeloneuropathyDate & Time: June 27, 2022, 12:30 1:15 p.m. CEST

About SBT101 SBT101 is the first clinical-stage adeno-associated virus (AAV)-based gene therapy candidate for people with adrenomyeloneuropathy (AMN). SBT101 was designed to compensate for the disease-causing ABCD1 mutation. In preclinical studies, treatment with SBT101 demonstrated dose-dependent improvement of disease markers and functional improvement in AMN mouse models. SBT101 was also shown to be well-tolerated in non-human primates at six months post-treatment. The clinical program for SBT101 builds on this positive preclinical data, plus the companys already deep understanding of the underlying pathophysiology of the disease and the patient experience of AMN.

SwanBio expects to initiate a randomized, controlled Phase 1/2 clinical trial designed to assess the safety and efficacy of SBT101 in patients with AMN in the second half of 2022. In early 2022, the FDA cleared SwanBios Investigational New Drug application for SBT101 and granted SBT101 Fast Track and Orphan Drug Designation.

About Adrenomyeloneuropathy Adrenomyeloneuropathy (AMN) is a progressive and debilitating neurodegenerative disease caused by mutations in the ABCD1 gene that disrupt the function of spinal cord cells and other tissues. AMN is characterized by loss of mobility in adulthood, incontinence, pain, and sexual dysfunction, which all affect quality of life. Between 8,000-10,000 men in the United States and European Union are living with AMN. There are no approved therapies for the treatment of the disease; current standard of care is limited to symptom management.

About SwanBio Therapeutics SwanBio Therapeutics is a gene therapy company that aims to bring life-changing treatments to people with devastating, inherited neurological conditions. SwanBio is advancing a pipeline of gene therapies, designed to be delivered intrathecally, that can address targets within both the central and peripheral nervous systems. This approach has the potential to be applied broadly across three disease classifications spastic paraplegias, monogenic neuropathies, and polygenic neuropathies. SwanBios lead program is being advanced toward clinical development for the treatment of adrenomyeloneuropathy (AMN). SwanBio is supported by long-term, committed investment partners, including its primary investors Syncona, Ltd. (lead investor and majority shareholder) and Mass General Brigham Ventures. For more information, visit SwanBioTx.com.

References

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Ambys Medicines Announces Formation of Clinical and Scientific Advisory Boards with Leading Liver Disease and Cell and Gene Therapy Experts – Business…

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Ambys Medicines, a company pioneering cell-replacement therapies for patients with liver disease, today announced the formation of its clinical and scientific advisory boards comprising leading clinical experts in liver disease and hepatocyte transplantation, and world-class scientists pioneering cell and gene technologies.

The clinical advisory board provides guidance on advancing Ambyss lead program, AMI-918, through the clinic and provides critical input on clinical trial design and patient selection. The scientific advisory board will provide a cross-discipline perspective on applying cutting-edge technology to Ambyss cell therapy platform to progress its discovery pipeline of next generation cell therapies.

Were honored to work with such an esteemed and diverse group of experts in liver disease, hepatocyte transplantation, and cell and gene therapies whose collective experience will be highly valuable as we finalize our clinical development strategy for AMI-918 and progress our genetically engineered hepatocyte follow-on programs, said Ronald Park, M.D., Chief Executive Officer of Ambys Medicines. Were grateful for the engagement and support from our advisors as we work to bring first-in-class hepatocyte replacement therapies to liver failure patients who currently lack treatment options.

Each of our advisors brings incredible knowledge and expertise in their respective fields that will be instrumental to Ambys as we continue to broaden our pipeline and move closer to becoming a clinical-stage company, said Markus Grompe, M.D., Founder and Chief Scientific Officer of Ambys Medicines. Were excited to partner together to realize the potential of our novel replacement cell therapy platform in restoring lost hepatic function to patients with acute or chronic liver failure and genetic liver diseases.

Clinical Advisory Board

Scientific Advisory Board

About Ambys MedicinesAmbys Medicines is focused on pioneering cell replacement therapies for patients with liver failure. Ambyss proprietary platform enables the company to be the first and only company able to develop and manufacture functional human hepatocytes at scale. Our scientific approach has the potential to fundamentally transform the treatment paradigm for patients with acute and chronic liver failure and genetic diseases of the liver. Our lead program, AMI-918, is a hepatocyte replacement cell therapy in development to restore lost hepatic function. Beyond AMI-918, we are building a pipeline of next-generation modified hepatocytes that will rapidly expand the range of treatable patient populations. Learn more at ambys.com and follow us on Twitter, LinkedIn and Instagram.

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Surgeon taking part in gene therapy trial to slow vision loss – KCRA Sacramento

that's the center of the macula right there. Okay, so if you had an area of degeneration over here or over here or over here, you would have no symptoms. But it's that center part that dr eric swan with the retina care center says causes vision loss once affected. And it can be *** little or *** lot depending on how much tissue has been lost due to age related dry macular degeneration. Typical patient comes to see me has the loss of central vision, they just can't read. They're having difficulties driving. And so this is *** huge impairment for patients because the tissue can't be regenerated. The goal is to slow progression. Dr swan is part of *** nationwide FDA approved investigative clinical trial. That involves *** one time surgery using *** patient's own cells to create more of *** certain protein. Thought to be low in patients with this eye disease. This is *** very novel technique. It's gene therapy. So we're actually injecting these genes underneath the retina and telling the cells to produce more of this protein. Dr swan is the first surgeon in Maryland to perform the surgery and says clinical trials are still in the early stages. Early detection is key and that's why exams he says are so important and why research is so crucial when it comes to quality of life issues like vision. It is I mean, you want your grandmother your love when your grandfather to actually be able to continue to drive and really to maintain their independence and that really is the most important for them, jennifer francie adi W. B. *** l tv 11 News.

Surgeon taking part in gene therapy trial to slow vision loss

Updated: 7:26 PM PDT Jun 25, 2022

A Baltimore doctor performed the first surgery in Maryland as part of a nationwide clinical trial to slow the progression of what's known as dry macular degeneration.Dr. Eric Suan, retinal surgeon at the Retina Care Center, said degeneration causes vision loss once affected. And it can be a little or a lot, depending on how much tissue has been lost due to age-related dry macular degeneration."The typical patient who comes to me has a loss of central vision," Suan said. "They just can't read, they're having difficulty driving, and so this is a huge impairment for patients."Because the tissue can't be regenerated, the goal is to slow progression.Suan is part of a nationwide Food and Drug Administration-approved investigative clinical trial that involves a one-time surgery using a patient's own cells to create more of a certain protein thought to be low in patients with this eye disease."This is a very novel technique. It's gene therapy. So, we are actually injecting these genes under the retina and telling the cells to produce more of this protein," Suan said.Suan said clinical trials are still in the early stages but that early detection is key, which makes eye exams important. Suan said research is crucial when it comes to a quality-of-life issue like vision."Do you want your grandmother and your loved one, grandfather, to actually be able to continue to drive to maintain independence? That really is the most important for them," Suan said.

A Baltimore doctor performed the first surgery in Maryland as part of a nationwide clinical trial to slow the progression of what's known as dry macular degeneration.

Dr. Eric Suan, retinal surgeon at the Retina Care Center, said degeneration causes vision loss once affected. And it can be a little or a lot, depending on how much tissue has been lost due to age-related dry macular degeneration.

"The typical patient who comes to me has a loss of central vision," Suan said. "They just can't read, they're having difficulty driving, and so this is a huge impairment for patients."

Because the tissue can't be regenerated, the goal is to slow progression.

Suan is part of a nationwide Food and Drug Administration-approved investigative clinical trial that involves a one-time surgery using a patient's own cells to create more of a certain protein thought to be low in patients with this eye disease.

"This is a very novel technique. It's gene therapy. So, we are actually injecting these genes under the retina and telling the cells to produce more of this protein," Suan said.

Suan said clinical trials are still in the early stages but that early detection is key, which makes eye exams important. Suan said research is crucial when it comes to a quality-of-life issue like vision.

"Do you want your grandmother and your loved one, grandfather, to actually be able to continue to drive to maintain independence? That really is the most important for them," Suan said.

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Surgeon taking part in gene therapy trial to slow vision loss - KCRA Sacramento

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