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Archive for the ‘Cardiac Stem Cells’ Category

Mountain News: Clinic advances stem-cell research – Pique Newsmagazine

VAIL, Colo. In 1988, George Gillett, who then owned what has become Vail Resorts, persuaded Dr. Richard Steadman to relocate his medical practice from Lake Tahoe to Vail. The Steadman Clinic soon became the go-to-place for athletes with knee and other joint problems.

It still is. Football quarterback Tom Brady has been there, soccer icon Pele and basketball power Yao Ming. Plus John Elway, Mario Lemieux, and Alex Rodriguez. Big names from the ski world, obviously. But also the drummer for the rock band U2, Larry Mullen, Jr.

Now, the clinic will be getting a new, 2,415-square-metre research lab courtesy of the Vail Valley Medical Center. The US$68 million facility will house the Steadman Philippon Research Institute’s labs for surgical skills, robotics, regenerative medicine, and bio-motion. The clinic and associated research institute together employ 190 people.

Research being conducted there is getting attention. A recent report in The Denver Post by staff writer John Meyer suggests you may have a stake in the work at the base of Vail Mountain. The story focused on the work of Dr. Johnny Huard, the chief scientific officer and director of the Center for Regenerative Sports Medicine.

Huard is trying to advance the techniques that allow people to heal more rapidly. The field is called biologics. Cells from the patient’s own body are used in concentrated injections to hasten repair of tissue at the site of the injury.

Stem cells and platelet-rich plasma therapy will someday delay age-related diseases and cut the recovery time from serious injuries.

“I don’t think we can reverse aging, but I think we can age better and recover from injury better,” said Dr. Marc Philippon, managing partner of the Steadman Clinic.

“As a surgeon, my biggest challenge is, if I cut on you there’s always that healing phase. We want you to recover faster. But the most important thing is prevention of injury. If your cells are aging better, you’ll have less injury.”

Before moving to Vail two years ago, Huard directed the Stem Cell Research Center at the University of Pittsburgh. In Vail, the researchers think injections of stem cells and PRP can help delay or prevent the need for joint replacements. At the adjacent Steadman Clinic, they can test the theories in clinical trials. Animal studies have already shown that young stem cells can rejuvenate old stem cells.

Huard advocates passionately harvesting stem cells from the umbilical cord of a newborn, freezing them at -80 degrees Fahrenheit (-62 C). Those cells can later be thawed and reintroduced into the body as younger and more robust stem cells than the ones that have aged in the patient.

An athlete who blows out an anterior cruciate ligament in training camp currently loses a full year. Being able to return to play sooner could dramatically change the recovery time for injuries.

As good as dead, skier survives a heart attack

JACKSON, Wyo. Imagine having a heart-attack in the backcountry. Just what do you think your odds are?

Mike Connolly, 61, was skiing on a ridge of Maverick Peak, in Grand Teton National Park, when he reported chest pains. Because they had cell phones, members of his party were able to summon help. A helicopter with three members of the Teton County Search and Rescue was dispatched.

At the scene, Connolly went into cardiac arrest. He ceased breathing and he had no pulse. Members of his group began cardiopulmonary resuscitation. Then rescuers arrived with an automated defibrillator. They shocked Connolly once, and he regained a pulse and began breathing again. A short time later, he was able to verbally communicate with those around him.

Uber drivers now ply roads

JACKSON, Wyo. Because of new state legislation, Uber and Lyft are now allowed to operate in Wyoming. Uber took just hours after the bill was signed before opening its car doors for business in Jackson Hole, reported the News&Guide.

Uber drivers must have valid licences, registration, proof of insurance, and a passing grade on an online safety screening. Uber allows drivers to use their own cars or commercially licensed vehicles.

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Mountain News: Clinic advances stem-cell research – Pique Newsmagazine

Stem Cell Therapy receives FDA Boost to enter the US Market – Labiotech.eu (blog)

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TiGenix has receivedpositive feedback from the FDA on an improved global phase III trial protocol for its lead candidateCx601 for Crohns disease. This is expected tospeed up US approval.

TiGenix is a Belgian companydevelopingstem cell therapies. The biotech is currently pushing its lead candidateCx601to the market for the treatment ofcomplex perianal fistulas in Crohns disease patients. Cx601 recently revealedpositive resultsin a European phase III study.

Following these results, the company submitted a number of technical adjustments for itspivotal phase III study for Biologics License Application (BLA) in the US, which were now approved by the FDA and are expected to acceleratethe process to US marketing authorization.

TiGenix is wellknown for its productChondroCellect, which was the first cell therapyto reach approval on the European market for the repair of knee cartilage.After the companyrecently withdrew its market authorization for this product, due to a lack of reimbursement, the biotech is focusing on its new leadCx601.

Thisproduct, currently awaiting EMA approval, consists ofallogeneic expanded adipose-derived stem cells (eASC), which are indicated for the treatment ofperianal fistulas in Crohns disease. The therapeuticeffects of eASCs are based on immunomodulatory abilities of these stem cells, which canrestore immune balance by suppressing a variety of immune cell subsets and inducing the generation of regulatory T cells.

Areas of the colon commonly affected duringCrohns disease

The current approval from the FDA will allow TiGenix to file the BLAbased on the efficacy and safety follow-up of patients at week 24, instead of week 52.The FDA has also agreed to accept fewer patients than originally planned in the study and endorsed a broader target population that will ultimately facilitate the recruitment process.

We believe that this revised protocol will allow us to file for approval one year earlier than we had originally plannedconcludedMaria Pascual, VP Regulatory Affairs & Corporate Quality of TiGenix

The current amendments will allow TiGenix to push its therapyto the US market even faster, which might pivotal for the company in light of its financial situation. After its shares had reached a low of22 cents back in 2013, the share price is currently still under 1. Withits low 34M IPO on Nasdaq in the end of last year, its market cap is stillonly at 191M. A low sum for a late stage clinical company.

As the EMAapproval forCx601 is expected soon, which will then be commercialized by Takeda, the company may actually be underestimated. The biotech recently started a new Phase Ib/IIa trial to testCx611 as a treatment for sepsis in patients with pneumonia.

Asecond platform consisting of transplanted allogeneic cardiac stem cells (AlloCSC)is currently in Phase II for acute myocardial infarction. It seems like TiGenix is definitely clinging toits position as one of the pioneers in stem cell-based therapies.

Images via shutterstock.com / CI Photos and CC 3.0 /RicHard-59

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Stem Cell Therapy receives FDA Boost to enter the US Market – Labiotech.eu (blog)

Using Stem Cells to Predict Toxicity of Chemotherapy Drugs … – ScienceBlog.com (blog)

A team of scientists has developed a new safety index for a common group of chemotherapy drugs, by using a stem cell model to screen such therapies for their potential to damage patients hearts.

The study, published in Science Translational Medicine, was co-authored by Paul Burridge, PhD, assistant professor of Pharmacology.

Tyrosine kinase inhibitors (TKIs), a class of chemotherapy drugs, have become increasingly important in treating many types of cancer. But almost all TKIs are also associated with cardiovascular side effects ranging from arrhythmias to heart failure and there has not yet been an effective tool to predict this cardiotoxicity.

In the current study, the scientists demonstrated that human-induced pluripotent stem cells can be used to model how TKIs might affect the hearts of patients receiving chemotherapy.

To do so, the scientists took stem cells from both a control group and patients with cancer and reprogrammed them to become cardiomyocytes, or heart muscle cells. Using high-throughput screening, they then evaluated how the heart cells responded to treatment with 21 different FDA-approved TKIs, looking at factors like cell survival, signaling and alterations in their ability to beat properly.

With the stem-cell data, the scientists were able to create a cardiac safety index, which ranks the TKIs on their likelihood of inflicting heart damage. That index correlates with the toxicity that has been observed in patients clinically a validation that suggests the screening system might be a powerful tool in predicting toxicity before therapies are ever administered to patients.

Future research could establish even more specific predictions, by comparing the genomes of patients who might experience a certain drug side effect, such as atherosclerosis, with those who dont. Long-term, what my lab is interested in is taking a patients whole genome and, based on the work weve done in the past, being able to predict whether a patient will have an adverse drug event, said Burridge, also a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. This is the whole idea of pharmacogenomics, or precision medicine: Everyone is going to have a different response to a drug, and that response good or bad is already encoded in all of us.

In the study, the scientists also discovered that administering insulin or insulin-like growth factor 1 alongside TKIs seemed to protect against some of the heart damage associated with the drugs. While its still early, this is the first step toward opening up a whole new field of identifying cardioprotectants to reduce the toxicity of these drugs, Burridge said.

The research was supported by the National Institutes of Health (NIH) grants K99/R00 HL121177, 14BGIA20480329, R01 HL132875, R01 HL130020, R01 HL128170, R01 HL123968, and R24 HL117756; the NIH Directors Pioneer Award; the American Heart Association Predoctoral Fellowship; the American Heart Association Beginning Grant-in-Aid; American Heart Association Grant-in-Aid; the American Heart Association Established Investigator Award; the National Science Foundation Graduate Research Fellowship; the Endowed Faculty Scholar Award of the Lucile Packard Foundation for Children and Child Health Research Institute at Stanford and Burroughs Wellcome Foundation Innovation in Regulatory Science.

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Using Stem Cells to Predict Toxicity of Chemotherapy Drugs … – ScienceBlog.com (blog)

Student profile: Keegan Mendez – Harvard School of Engineering and Applied Sciences

This sky-diving, squash-playing, thrill-seeking student is gearing up for her next great adventurein biomedical engineering research and discovery.

Why did you decide to concentrate in biomedical engineering?

As a child, I always had a love of math and science, and I liked to use my hands to create thingsI shunned Barbie dolls for building blocks. I was already a math and science nerd, but what appealed to me about bioengineering specifically is the breadth and diversity of research options, from organs on a chip to medical device design, and everything in between. The research that is happening right nowlike trying to grow a human heart outside the bodyis so cutting-edge and exciting.

Tell us about some of the bioengineering research youve had the opportunity to conduct at SEAS.

During my sophomore year, I began working in David Mooneys lab on developing the TheraCardium, which is a cardiac device for stem cell delivery to the heart for patients who have suffered a heart attack. The device supports regrowth of the damaged tissue and helps to prevent scarring of the dead heart muscle, in an effort to help prevent future cardiac events.

Mendez works on a biomedical research project in the Mooney lab. (Photo by Eliza Grinnell/SEAS Communications.)

Why was that research experience beneficial for you?

By working on that project, I experienced many different types of research, from preclinical studies in animals, to tissue engineering, to the materials science involved in building the device, to various soft robotic manufacturing techniques. I had the opportunity to work with many new technologies that I hadnt been exposed to in the classroom.

What is the topic of your senior thesis project?

Drawing on my work on the TheraCardium, I am designing a soft robotic drug delivery system. The device involves a hydrogel adhered to a soft robotic balloon that could be placed on the surface of the heart to directly delivery therapy to the muscle. Inflation of the balloon stretches the mesh size of the hydrogel, enabling delivery of the drug encapsulated within the hydrogel. By controlling the balloon inflation, we can achieve radio control, or the ability for on-and-off delivery. The device could also incorporate multiple balloons, delivering different drugs to separate areas of the heart.

In addition to your academic and research success, youve also served as co-captain of the Harvard Womens Squash team. How did you get involved with that sport?

I started playing squash competitively when I was 8 years old. The neighborhood where I grew up had one of the best junior squash programs in the country. I was inspired by my older sister, Haley, who is a great squash player. She was recruited to play squash at Harvard. When it came time for me to apply to college, the coach told me he had used all his recruiting spots, but if I could get into Harvard, I could play, too. It all worked out, and Ive been on the team for the past four years. There is a big mental aspect to squash. Your tactics and shot selection become critically important at the college level, since all the players are very technically proficient.

Are you and your older sister squash rivals?

Were a very competitive family. When we play board games, it gets so competitive it is almost scary. Haley has always been better than I was on the squash court, but we still play all the time. We are definitely competitive academically, as well, and while I love squash, I feel like my true passion lies in academics.

When playing squash at the college level, tactics and shot selection become incredibly important, Mendez said. (Photo by Eliza Grinnell/SEAS Communications.)

Do you think academics will play a role in your future plans?

Definitely. I am planning to apply for Ph.D. programs in bioengineering, and Harvard is my first choice. Ive been really excited about the research Ive been able to do as an undergraduate, and I want to continue contributing to science and advancing the field. The projects Ive been working on are just so cool, and I want to keep my research momentum going.

How do you feel that SEAS has prepared you for your future?

Beyond learning the technical skillslike how to code and use machinesbeing able to work closely with my peers on teams has given me a lot of confidence. As an engineer, you need to be able to communicate ideas effectively to people who may not be engineers. Collaboration is key within engineering, with each team member contributing an important piece to the puzzle. I have also been humbled, and learned when to ask for help, when to seek out peers, and when to work collaboratively in groups as opposed to attempting to do everything myself.

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Student profile: Keegan Mendez – Harvard School of Engineering and Applied Sciences

Opinion/Commentary: Global stem cell therapy market to showcase … – The Daily Progress

LONDON Technavio analysts forecast the global stem cell therapy market to grow at a compound annual growth rate of close to 37 percent during the forecast period, according to their latest report.

The research study covers the present scenario and growth prospects of the global stem cell therapy market for 2017-2021. To determine the market size, the study considers revenue generated from allogenic and autogenic stem cell therapies.

The Americas are the largest regional segment of the global stem cell therapy market, responsible for generating over 56 percent of the total revenue (2016 figures). The region is expected to continue market dominance through the forecast period, driven by increasing demand for stem cell therapy products and investments into R&D.

Technavio analysts highlight the following factors as contributing to the growth of the global stem cell therapy market:

Increase in federal funding in stem cell therapy.

Sapna Jha, one of the lead research analysts at Technavio for medical imaging research, says, Many stem cell research institutes and small companies are involved in cutting-edge R&D and are yielding encouraging results. These institutions are witnessing an increased flow of investments from federal organizations, due to the realization of the importance of regenerative medicine.

The U.S. National Institutes of Health, a major funding government organization invested approximately USD 1.5 billion in stem cell research projects in 2016. Similarly, several state-level organizations such as California Institute for Regenerative Medicine has contributed USD 3 billion to stem cell research in 2014. Such funding will help various research institutes to discover and develop regenerative medicines, which will boost the global regenerative medicine market enormously.

Growing demand for personalized medicine.

The health care sector is creating a high demand for personalized medicine, which could offer game-changing opportunities for the vendors. These medicines offer treatments based on the individual characteristics, needs, and preferences, which will vastly improve the quality of health care. Individuals are increasingly banking their stem cells for future treatments. Research organizations are also extensively exploring ways to develop personalized treatments with stem cells, which could eventually erase the conventional medicine system and help in the effective treatment of various diseases such as diabetes and cancer.

Demand for development of effective drugs for cardiology and degenerative disorders.

There has been an increased demand to develop effective drugs for cardiology and degenerative disorders, for which there were no effective treatment plans before the advent of stem therapies. The discovery of possible cardiac stem cells uncovered new arenas to repair hearts injured due to acute myocardial infarction or coronary artery disease, says Sapna.

Researchers are studying and developing approximately 19 product candidates for the treatment of cardiac disorders, with eight of them in Phase III, and six in Phase II.

Technavio is a global technology research and advisory company. This report was made available through The Associated Press.

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Opinion/Commentary: Global stem cell therapy market to showcase … – The Daily Progress

Stem cell therapy can help in treating diabetic heart disease – Business Standard

Recent advancements in stem cells research have given hope for successfully treating diabetic heart disease (DHD), renowned New Zealand-based researcher in cardiovascular diseases Dr Rajesh Katare said on Tuesday.

DHD affected the muscular tissues of the heart leading to complications and it had been demonstrated that resident stem cells of myocardium can be stimulated to repair and replace e degenerated cardiac myocytes resulting in a novel therapeutic effect and ultimately cardiac regeneration, he said.

Katare, Director of Cardiovascular Research Division in the University of Otago, New Zealand, was delivering the keynote address at the continuing medical education programme on “Role of Micro-RNAs and stem cells in cardiac regeneration in diabetic heart disease” at the Karaikal campus of premier health institute JIPMER.

Presenting clinical evidences, Katare said stem cell therapy certainly presented a new hope for successfully treating DHD.

Jawaharlal Institute of Post Graduate Medical Education (JIPMER) Director Dr Subash Chandra Parija pointed out that it was the first such programme on the role of stem cells in cardiac regeneration in the whole of the country.

He said as diabetes was highly prevalent in the country, providing treatment for DHD had become a big challenge. Patients suffering from the condition have to undergo lifelong treatment and medications. “In this backdrop, advancements in stem cell therapy assume significance,” he said. (REOPENS MES10)

Parija also said the government general hospital in

Karaikal being currently used by JIPMER for clinical teaching of students would have upgraded facilities.

He said a new building for the college would be constructed at a cost of Rs 497.10 crore soon.

The proposed up-gradation of the GH having 506 beds would help in imparting advanced clinical teaching and effective exposure of the medicos to various nuances of the diagnosis.

The Director also said JIPMER (Karaikal) had drawn up special post-graduate and fellowship programmes including on family medicine, tropical medicine, trauma care and cancer management.

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Stem cell therapy can help in treating diabetic heart disease – Business Standard

Stem cell therapy can help treat diabetic heart disease – Economic Times

KARAIKAL: Recent advancements in stem cells research have given hope for successfully treating diabetic heart disease (DHD), renowned New Zealand-based researcher in cardiovascular diseases Dr Rajesh Katare said today.

DHD affected the muscular tissues of the heart leading to complications and it had been demonstrated that resident stem cells of myocardium can be stimulated to repair and replace e degenerated cardiac myocytes resulting in a novel therapeutic effect and ultimately cardiac regeneration, he said.

Katare, Director of Cardiovascular Research Division in the University of Otago, New Zealand, was delivering the keynote address at the continuing medical education programme on “Role of Micro-RNAs and stem cells in cardiac regeneration in diabetic heart disease” at the Karaikal campus of premier health institute JIPMER.

Presenting clinical evidences, Katare said stem cell therapy certainly presented a new hope for successfully treating DHD.

Jawaharlal Institute of Post Graduate Medical Education (JIPMER) Director Dr Subash Chandra Parija pointed out that it was the first such programme on the role of stem cells in cardiac regeneration in the whole of the country.

He said as diabetes was highly prevalent in the country, providing treatment for DHD had become a big challenge. Patients suffering from the condition have to undergo lifelong treatment and medications. “In this backdrop, advancements in stem cell therapy assume significance,” he said.

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Stem cell therapy can help treat diabetic heart disease – Economic Times

StemBioSys Lands Experimental UT Tech That Finds Young Stem Cells – Xconomy

Xconomy Texas

San Antonio StemBioSys, the life sciences company with a system for growing stem cells, has licensed an experimental technology from University of Texas Health San Antonio that may help identify healthy young adult stem cells among large pools of other cells.

Theres plenty of research examining how to possibly use adult stem cells as treatments for medical conditions, ranging from cardiac disease to metabolic disorders, but current uses are rather limited to therapies like bone-marrow transplants for blood disorders, especially in children. Treatments that use patients own stem cells may be safer than using stem cells from someone else because they might reduce the potential for an immune response, according to StemBioSys CEO Bob Hutchens. Thats still theoretical, he says.

Finding large quantities of usable adult stem cells is difficult, though. StemBioSys believes its new technology can potentially identify a few thousand high-quality, young stem cells from a sample of tens of thousands of cells taken from a patient, Hutchens sayspotentially being a key word.

The research is quite earlythe technology has only been studied in animal models and in vitro, and StemBioSys is in the process of applying for federal grants to take the research into animal trials. If StemBioSys new intellectual property can successfully isolate the stem cells, Hutchens says they could grow more of them with StemBioSys core product.

StemBioSys sells a so-called extracellular matrix product made of proteins that provide a hospitable environment for stem cells, helping them divide and produce more stem cells.

Whats intriguing to us is that its a really interesting application of our technology, Hutchens says. You take this combination of identifying this very small population of young healthy cells in elderly people, and use our technology to expand it.

If the company can indeed find the young stem cells of a single patient and replicate them, it would give researchers and physician an accessible pool of the cells that theyd want for potential stem cell transplants and other treatments, Hutchens says.

Terms of the deal werent disclosed. StemBioSys, which was founded based on other University of Texas System research, acquired a portfolio of issued and pending patents. Famed MIT researcher and Xconomist Robert Langer is on the companys board of directors.

Again, theres plenty to prove out with this early stage research, so it will take time before any potential commercialization comes to fruition. Travis Block, the researcher who helpeddevelopthe technology while earning his PhD. last year at the University of Texas Health Science Center at San Antonio, will help shepherd the project along and other regenerative medicine work as StemBioSyss senior scientist.

David Holley is Xconomy’s national correspondent based in Austin, TX. You can reach him at dholley@xconomy.com

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StemBioSys Lands Experimental UT Tech That Finds Young Stem Cells – Xconomy

Johns Hopkins Medicine, Maryland Stem Cell Research Fund and … – Business Wire (press release)

SAN CARLOS, Calif. & BALTIMORE–(BUSINESS WIRE)–Johns Hopkins Medicine, the Maryland Stem Cell Research Fund (MSCRF) and BioCardia, Inc. (OTC:BCDA) today announced that the first patient has been treated in the pivotal Phase III CardiAMP clinical trial of a cell-based therapy for the treatment of ischemic heart failure that develops after a heart attack. The first patient was treated at Johns Hopkins Hospital by a team led by Peter Johnston, MD, a faculty member in the Department of Medicine and Division of Cardiology, and principal investigator of the trial at Johns Hopkins.

The investigational CardiAMP therapy is designed to deliver a high dose of a patients own bone marrow cells directly to the point of cardiac dysfunction, potentially stimulating the bodys natural healing mechanism after a heart attack.

The patient experience with CardiAMP therapy begins with a pre-procedural cell potency screening test. If a patient qualifies for therapy, they are scheduled for a bone marrow aspiration. A point of care cell processing platform is then utilized to concentrate the autologous bone marrow cells, which are subsequently delivered in a minimally-invasive procedure directly to the damaged regions in a patients heart.

This cell-based therapy offers great potential for heart failure patients, said Carl Pepine, MD, professor and former chief of cardiovascular medicine at the University of Florida, Gainesville and national co-principal investigator of the CardiAMP trial. We look forward to validating the impact of the therapy on patients quality of life and functional capacity in this important study.

In addition to Dr. Johnston, the CardiAMP research team at Johns Hopkins includes Gary Gerstenblith, MD, Jeffrey Brinker, MD, Ivan Borrello, MD, Judi Willhide, Katherine Laws, Audrey Dudek, Michele Fisher and John Texter, as well as the nurses and technicians of the Johns Hopkins Cardiovascular Interventional Laboratory.

Funding the clinical trial of this cell therapy, which could be the first cardiac cell therapy approved in the United States, is an important step towards treatments, said Dan Gincel, PhD., executive director of the MSCRF at TEDCO. Through our clinical program, we are advancing cures and improving healthcare in the State of Maryland.

The CardiAMP Heart Failure Trial is a phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at up to 40 centers nationwide, which includes an optional 10-patient roll-in cohort. The primary endpoint for the trial is a significant improvement in Six Minute Walk distance at 12 months post-treatment. Study subjects must be diagnosed with New York Heart Association (NYHA) Class II or III heart failure as a result of a previous heart attack. The national co-principal investigators are Dr. Pepine and Amish Raval, MD, of the University of Wisconsin.

For information about eligibility or enrollment in the trial, please visit http://www.clinicaltrials.gov or ask your cardiologist.

About BioCardia BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the companys biotherapeutic product candidates in clinical development. For more information, visit http://www.BioCardia.com.

About Johns Hopkins Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is one of the leading health care systems in the United States. Johns Hopkins Medicine unites physicians and scientists of the Johns Hopkins University School of Medicine with the organizations, health professionals and facilities of The Johns Hopkins Hospital and Health System. For more information, visit http://www.hopkinsmedicine.org.

About Maryland Stem Cell Research Fund The Maryland Stem Cell Research Act of 2006was established by the Governor and the Maryland General Assembly during the 2006 legislative session and created the Maryland Stem Cell Research Fund. This fund is continued through an appropriation in the Governor’s annual budget. The purpose of the Fund is to promote state-funded stem cell research and cures through grants and loans to public and private entities in the State. For more information, visit http://www.MSCRF.org.

Forward Looking Statements This press release contains forward-looking statements as that term is defined under the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, among other things, references to the enrollment of our Phase 3 trial, commercialization and efficacy of our products and therapies, the product development timelines of our competitors. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardias business and product development plans, competition in the industry in which BioCardia operates and overall market conditions, and whether the combined funds will support BioCardias operations and enable BioCardia to advance its pivotal Phase 3 CardiAMP cell therapy program. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

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Johns Hopkins Medicine, Maryland Stem Cell Research Fund and … – Business Wire (press release)

TiGenix to present at Cowen’s 37th Annual Health Care Conference in Boston – EconoTimes

Wednesday, March 1, 2017 6:01 AM UTC

PRESS RELEASE

TiGenix to present at Cowen’s 37thAnnual Health Care Conference in Boston

Leuven (BELGIUM) – 1st March, 2017, 07:00h CET – TiGenix NV (Euronext Brussels and Nasdaq: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced that Eduardo Bravo, CEO of TiGenix, will be presenting at the 37th Annual Cowen and Company’s Health Care Conference in Boston (USA) at The Boston Marriott Copley Place on Monday, March 6 at 3:20-3:50PM (EST) in Regis, 3rd Floor (breakout at 4:00 PM-04:30PM (EST) at Boston University, 3rd Floor).

The presentation will be webcast live and can be accessed on the day of the event at this link. A replay of the webcast will be available on the Company’s website for 30 days following the presentation. To ensure timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast.

The TiGenix management team will be available for one-to-one meetings from Monday, March 6th to Wednesday, March 8th. Please contact Investor Relations at Investor@tigenix.com for a meeting request.

For more information:

Claudia D’Augusta Chief Financial Officer T: +34 91 804 92 64 claudia.daugusta@tigenix.com

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Our lead product candidate from the adipose-derived stem cell technology platform is Cx601, which is in registration with the European Medicines Agency for the treatment of complex perianal fistulas in Crohn’s disease patients. Our adipose-derived stem cell product candidate Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product candidate, AlloCSC-01, is currently in a Phase II clinical trial in Acute Myocardial Infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain).

About Cx601

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) locally injected. Cx601 is an investigational agent being developed for the treatment of complex perianal fistulas in Crohn’s disease patients with inadequate response to at least one conventional or biologic therapy including antibiotics, immunosuppressants, or anti-TNF agents. Crohn’s disease is a chronic inflammatory disease of the intestine and patients can suffer from complex perianal fistulas for which there is currently no effective treatment. In 2009, the European Commission granted Cx601 orphan designation for the treatment of anal fistulas, recognizing the debilitating nature of the disease and the lack of treatment options. Cx601 has met the primary end-point in the Phase III ADMIRE-CD study in Crohn’s disease patients with complex perianal fistula, a randomized, double-blind, placebo-controlled trial run in Europe and Israel and designed to comply with the requirements laid down by the EMA. ‘Madrid Network’ issued a soft loan to help finance this Phase III study, which was funded by the Secretary of State for Research, Development and Innovation (Ministry of Economy and Competitiveness) within the framework of the INNTEGRA plan. The study’s primary endpoint was combined remission, defined as clinical assessment at week 24 of closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections >2cm confirmed by MRI. In the ITT population (n=212), Cx601 achieved statistically significant superiority (p=0.024) on the primary endpoint with 50% combined remission at week 24 compared to 34% in the placebo arm. Efficacy results were robust and consistent across all statistical populations. Treatment emergent adverse events (non-serious and serious) and discontinuations due to adverse events were comparable between Cx601 and placebo arms. The 24-weeks results have been published by The Lancet, one of the most highly regarded and well known medical journals in the world. The Phase III study has completed a follow-up analysis at 52 weeks confirming its sustained efficacy and safety profile. Top line follow-up data showed that in the ITT population Cx601 achieved statistical superiority (p=0.012) with 54% combined remission at week 52 compared to 37% in the placebo arm. The 52-week data also showed a higher rate of sustained closure in those patients treated with Cx601 and in combined remission at week 24 (75.0%) compared to patients in the placebo group (55.9%). Based on the positive 24-weeks Phase III study results, TiGenix has submitted a Marketing Authorization Application to the EMA in early 2016. TiGenix is preparing to develop Cx601 in the U.S. after having reached an agreement with the FDA through a special protocol assessment procedure (SPA) in 2015. On July 4, 2016 TiGenix entered into a licensing agreement with Takeda, a pharmaceutical company leader in gastroenterology, whereby Takeda acquired an exclusive right to commercialize Cx601 for complex perianal fistulas in Crohn’s patients outside of the U.S.

Forward-looking information

This press release may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company’s control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this press release. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

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TiGenix to present at Cowen’s 37th Annual Health Care Conference in Boston – EconoTimes

Stem cell therapy can help in treating diabetic heart disease – India.com

Karaikal, Feb 28 (PTI) Recent advancements in stem cells research have given hope for successfully treating diabetic heart disease (DHD), renowned New Zealand-based researcher in cardiovascular diseases Dr Rajesh Katare said today.

DHD affected the muscular tissues of the heart leading to complications and it had been demonstrated that resident stem cells of myocardium can be stimulated to repair and replace e degenerated cardiac myocytes resulting in a novel therapeutic effect and ultimately cardiac regeneration, he said.

Katare, Director of Cardiovascular Research Division in the University of Otago, New Zealand, was delivering the keynote address at the continuing medical education programme on Role of Micro-RNAs and stem cells in cardiac regeneration in diabetic heart disease at the Karaikal campus of premier health institute JIPMER.

Presenting clinical evidences, Katare said stem cell therapy certainly presented a new hope for successfully treating DHD.

Jawaharlal Institute of Post Graduate Medical Education (JIPMER) Director Dr Subash Chandra Parija pointed out that it was the first such programme on the role of stem cells in cardiac regeneration in the whole of the country.

He said as diabetes was highly prevalent in the country, providing treatment for DHD had become a big challenge.

Patients suffering from the condition have to undergo lifelong treatment and medications. In this backdrop, advancements in stem cell therapy assume significance, he said.

This is published unedited from the PTI feed.

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Stem cell therapy can help in treating diabetic heart disease – India.com

Canadian Pacific makes a $1 million gift to fund stem cell research at the CHU Sainte-Justine – New hope for … – Canada NewsWire (press release)

From left to right: Dr. Fabrice Brunet, The Honorable Michael M Fortier, Mr. Keith Creel, President and CEO of Canadian Pacific, Dr. Gregor Andelfinger, Ms. Maud Cohen, Ms. Janice Pierson, Mr. Richard Lanoue, Mher Mike Stepanian, Samuel Gauthier, Mariama Hawa Barry, Samy Touati, Tyler Lanoue and Olivier Boissonneault. (CNW Group/CHU Sainte-Justine Foundation)

MONTRAL, Feb. 27, 2017 /CNW Telbec/ -An extraordinary $1 million commitment from Canadian Pacific (CP) towards stem cell research will allow the CHU Sainte-Justine to lead the way in developing new treatments to transform the lives of children suffering from complex congenital heart defects. Currently, there is no treatment available to provide a permanent means of repairing the heart. Today, patients and cardiac experts gathered to recognize the major impact of such strong support for research at the CHU Sainte-Justine, as well as the national importance of research in the development of innovative new stem cell technologies.

Thanks to this exceptional gift, CP is making possible the creation of Quebec’s first platform for stem cell research and pediatric regenerative medicine. “These funds will allow us to purchase new equipment and recruit an additional researcher, which will significantly accelerate essential research, namely the identification of the mechanisms that form the heart and the types of intervention that can halt the progression of cardiac illnesses in children,” stated Dr.Gregor Andelfinger, pediatric cardiologist at the CHU Sainte-Justine and associate research professor in the Department of Pediatrics at the Universit de Montral. “Our aim is to put in place biological factory, capable of producing cardiac tissues from stem cells,” he added.

Research remains the best means of understanding, improving the treatment of, and curing congenital heart defects, which are the most commonly occurring birth defects in the world. They affect one in 80 children in Canada every year, many of whom eventually develop fatal heart failure.

“For over a decade, knowledge and understanding about heart defects have grown considerably at the CHU Sainte-Justine, along with the development of new tools for the genetic analysis of families where several family members suffer from a heart defect. Thanks to its team of experts specializing in pediatrics, cardiology, and congenital malformations, the CHU Sainte-Justine is a leader in providing better diagnoses and better targeted therapies to treat congenital heart defects,” stated Mr. Fabrice Brunet, CEO of the CHUM-CHU Sainte-Justine.

Ms. Maud Cohen, CEO of the CHU Sainte-Justine Foundation, expressed gratitude for CP’s generous support, which provides the hope of regenerating cardiac tissue in babies affected by congenital heart defects. “I am thrilled that the CHU Sainte-Justine is showing such leadership in pediatric regenerative medicine in Quebec, while also increasing our national and international outreach. The CHU Sainte-Justine Foundation is very proud to have the support of CP as a major donor to the Healing More Better campaign. Not only does this remarkable $1 million gift allow for the development of new cures to help save the lives of thousands of children suffering from cardiovascular diseases, but it will also serve as a driver for future funding. This support will enable Dr. Andelfinger’s team to quickly undertake activities that show promising early results,” she said.

“Since 2014, through our CP Has Heart program, we have been committed to making communities stronger and healthier thanks to research, treatment and prevention. With today’s announcement, we have now donated nearly $10 million to this important cause” said Mr. Keith Creel, CP’s President and CEO. “When we learned that the CHU Sainte-Justine was seeking to accelerate stem cell research, an extremely promising avenue for the repair of congenital heart defects, we immediately felt that it was an initiative we wanted to support. We firmly believe that a partnership with such a renowned institution as the CHU Sainte-Justine to create the first pediatric research platform in Quebec will significantly improve upon current treatments. This will ensure that the thousands of babies born with heart defects every year will have a chance to grow up with healthy hearts and live healthy lives,” Mr. Creel concluded.

For CP, this generous support for stem cell research is a way to pursue its mission to improve heart health throughout North America, and is a natural fit with a cause so close to the company’s heart.

The CHU Sainte-Justine Foundation is grateful for CP’s invaluable contribution, which will allow the teams at the CHU Sainte-Justine to continue to heal more children, better.

About the CHU Sainte-Justine FoundationThe CHU Sainte-Justine Foundation’s mission is to engage the community and support the CHU Sainte-Justine in its pursuit of excellence and its commitment to providing children and mothers with one of the highest levels of healthcare in the world, now and in the future. fondation-sainte-justine.org/en/

About the CHU Sainte-JustineThe Sainte-Justine university hospital centre (CHU Sainte-Justine) is the largest mother-child centre in Canada and the second largest pediatric hospital in North America. A member of the Universit de Montral extended network of excellence in health (RUIS), Sainte-Justine has 5,664 employees, including 1,578 nurses and nursing assistants; 1,117 other healthcare professionals; 502 physicians, dentists and pharmacists; 822 residents and over 200 researchers; 300 volunteers; and 3,400 interns and students in a wide range of disciplines. Sainte-Justine has 484 beds, including 35 at the Centre de radaptation Marie Enfant (CRME), the only exclusively pediatric rehabilitation centre in Quebec. The World Health Organization has recognized CHU Sainte-Justine as a “health promoting hospital.” chusj.org

About Canadian PacificCanadian Pacific (TSX:CP)(NYSE: CP) is a transcontinental railway in Canada and the United States with direct links to eight major ports, including Vancouver and Montreal, providing North American customers a competitive rail service with access to key markets in every corner of the globe. CP is growing with its customers, offering a suite of freight transportation services, logistics solutions and supply chain expertise. Visit cpr.ca to see the rail advantages of CP.

About CP Has HeartAt CP, we know that a railroad may serve as the arteries of a nation, but at its heart is community. That’s why, through CP Has Heart, we’ve already committed nearly $10 million to help improve the heart health of men, women and children across North America. And along the way, we’re showing heart whenever we can. Find out more on http://www.cpr.ca or @CPhasHeart.

SOURCE CHU Sainte-Justine Foundation

For further information: CHU Sainte-Justine Foundation, Delphine Brodeur, Director, Communication, public relations and donor relations, 514 345-4931, ext. 4356, dbrodeur@fondationSainteJustine.org

Originally posted here:
Canadian Pacific makes a $1 million gift to fund stem cell research at the CHU Sainte-Justine – New hope for … – Canada NewsWire (press release)

Heart failure BREAKTHROUGH: Stem cells trial offers hope to millions – Express.co.uk

GETTY

A high-level meeting has paved the way for global trials to begin on hundreds of patients.

British scientists have found a way to use stem cells to repair damaged tissue which could help millions living with heart failure, the UKs leading cause of death.

Scarring due to disease or heart attacks affects more than two million people in Britain.

This would be the biggest breakthrough since the first transplants three decades ago

Professor Steve Westaby

Initial trials involving more than 100 patients are being planned for the autumn at two London hospitals.

World renowned cardiac surgeon Professor Steve Westaby, who helped pioneer the revolutionary technique, said it had been thought that repairing heart damage was impossible.

But results from a long-term trial that began in Greece five years ago have shown that this is not the case.

Preliminary data from this trial showed the engineered stem cells, known as Heartcel, can reverse scarring by up to 79 per cent.

The data, presented at the European Society of Cell and Gene Therapy in Florence, showed an average of 40 per cent reduction in heart damage in those on the treatment.

Last month researchers finalised talks with European and US regulators to discuss the timetable for global trials next year involving 500 people.

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6 early signs of a heart attack

Professor Westaby, from the John Radcliffe Hospital, Oxford, said: I am very excited at the prospect of a trial which will hopefully lead to the availability of this stem cell treatment to thousands of patients annually in the UK.

Other scientists have tried in vain to repair damaged heart muscle using stem cells over the past few decades.

This is the first time scarring has been shown to be reversible. It could herald an end to transplants and lead to a treatment for heart failure within three to five years.

GETTY

Professor Westaby said: This would be the biggest breakthrough since the first transplants three decades ago.

Professor Westaby has been working on the technique for more than a decade and is carrying out the study with Professor Kim Fox, head of the National Heart and Lung Institute, at Imperial College London.

The implanted stem cells were created by medical outfit Celixir, co-founded by Nobel laureate Professor Martin Evans, the first scientist to culture mice embryonic stem cells in a laboratory.

Professor Westaby was inspired to work on the breakthrough in 1999 after a four-month-old baby girls heart healed itself after he carried out a major life-saving operation.

Kirsty Collier, from Swindon, was dying of a serious and rare heart defect. In a last ditch effort Professor Westaby cut away a third of her badly damaged heart.

GETTY

GETTY

Surprisingly it began to beat. Fourteen years later a scan has shown that the heart had healed itself.

Now Kirsty, 18, has a normal one. Professor Westaby said: She was essentially dead and was only resurrected by what I regarded at the time as a completely bizarre operation.

The fact there was no sign of heart damage told me there were foetal stem cells in babies hearts that could remove scarring of heart muscle. That never happens in adults.

Its all down to the clues we got from Kirstys operation.

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Heart failure BREAKTHROUGH: Stem cells trial offers hope to millions – Express.co.uk

Cardiac injury, recovery is topic of Osher lecture – Stowe Today

Dr. Jeffrey Spees, an associate professor of medicine at the University of Vermonts College of Medicine, will present Rescue and Repair of Cardiac Tissue After Injury: Turning Star Trek into Sesame Street, on Wednesday, March 1, at the Town and Country Resort, 876 Mountain Road, Stowe. Doors open at 1 p.m. and the lecture begins promptly at 1:30 p.m. This is the eighth Osher Lifelong Learning Institute lecture of the winter series.

Spees earned his Ph.D. in physiological and molecular ecology at the University of California, Davis. At UVM he teaches courses in developmental neurobiology, human structure and function and stem cells and regenerative medicine.

Spees has directed the Stem Cell Core in UVMs Department of Medicine and was one of the founding members of the New England Stem Cell Consortium. Spees and his colleagues have developed and applied for a patent for a therapy using a protein complex that is highly protective and keeps cells alive. He will discuss this research and its role in repairing cardiac tissue to improve cardiac function after a heart attack.

Vermont musicologist Joel Najman will present the final lecture of the winter series, Rock n Roll: From Elvis to Lady Gaga, on Wednesday, March 8.

The lecture is $5 and refreshments will be served after the talk. To check on weather cancellations, listen to WDEV 550 AM or WLVB 93.9 FM or call Town and Country Resort at 253-7595. To sponsor a lecture, a series or refreshments, call Dick Johannesen, 253-8475. Information: learn.uvm.edu/osher.

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Cardiac injury, recovery is topic of Osher lecture – Stowe Today

Nanostraw doesn’t destroy cells as it samples their guts – Futurity – Futurity: Research News

Cells within our bodies divide and change over time, with thousands of chemical reactions occurring within each cell daily. This makes it difficult for scientists to understand whats happening inside. New nanostraws offer a non-disruptive way to find out.

A problem with the current method of cell sampling, called lysing, is that it ruptures the cell. Once the cell is destroyed, it cant be sampled from again. This new sampling system relies on tiny tubes 600 times smaller than a strand of hair that allow researchers to sample a single cell at a time. The nanostraws penetrate a cells outer membrane, without damaging it, and draw out proteins and genetic material from the cells salty interior.

Its like a blood draw for the cell, says Nicholas Melosh, an associate professor of materials science and engineering at Stanford University and senior author of a paper describing the work in the Proceedings of the National Academy of Sciences.

The nanostraw sampling technique, according to Melosh, will significantly impact our understanding of cell development and could lead to much safer and effective medical therapies because the technique allows for long term, non-destructive monitoring.

What we hope to do, using this technology, is to watch as these cells change over time and be able to infer how different environmental conditions and chemical cocktails influence their developmentto help optimize the therapy process, Melosh says.

If researchers can fully understand how a cell works, then they can develop treatments that will address those processes directly. For example, in the case of stem cells, researchers are uncovering ways of growing entire, patient-specific organs. The trick is, scientists dont really know how stem cells develop.

For stem cells, we know that they can turn into many other cell types, but we do not know the evolutionhow do they go from stem cells to, say, cardiac cells? There is always a mystery. This sampling technique will give us a clearer idea of how its done, says Yuhong Cao, a graduate student and first author on the paper.

The sampling technique could also inform cancer treatments and answer questions about why some cancer cells are resistant to chemotherapy while others are not.

With chemotherapy, there are always cells that are resistant, says Cao. If we can follow the intercellular mechanism of the surviving cells, we can know, genetically, its response to the drug.

The sampling platform on which the nanostraws are grown is tinyabout the size of a gumball. Its called the Nanostraw Extraction (NEX) sampling system, and it was designed to mimic biology itself.

In our bodies, cells are connected by a system of gates through which they send each other nutrients and molecules, like rooms in a house connected by doorways. These intercellular gates, called gap junctions, are what inspired Melosh six years ago, when he was trying to determine a non-destructive way of delivering substances, like DNA or medicines, inside cells. The new NEX sampling system is the reverse, observing whats happening within rather than delivering something new.

Its a super exciting time for nanotechnology, Melosh says. Were really getting to a scale where what we can make controllably is the same size as biological systems.

Building the NEX sampling system took years to perfect. Not only did Melosh and his team need to ensure cell sampling with this method was possible, they needed to see that the samples were actually a reliable measure of the cell content, and that samples, when taken over time, remained consistent.

When the team compared their cell samples from the NEX with cell samples taken by breaking the cells open, they found that 90 percent of the samples were congruous. Meloshs team also found that when they sampled from a group of cells day after day, certain molecules that should be present at constant levels remained the same, indicating that their sampling accurately reflected the cells interior.

With help from collaborators Sergiu P. Pasca, assistant professor of psychiatry and behavioral sciences, and Joseph Wu, professor of radiology, Melosh and coworkers tested the NEX sampling method not only with generic cell lines, but also with human heart tissue and brain cells grown from stem cells. In each case, the nanostraw sampling reflected the same cellular contents as lysing the cells.

The goal of developing this technology, according to Melosh, was to make an impact in medical biology by providing a platform that any lab could build. Only a few labs across the globe, so far, are employing nanostraws in cellular research, but Melosh expects that number to grow dramatically.

We want as many people to use this technology as possible, he says.

Funding for the work came from the National Institute of Standards and Technology, the Knut and Alice Wallenberg Foundation, the National Institutes of Health, Stanford Bio-X, the Progenitor Cell Biology Consortium, the National Institute of Mental Health, an MQ Fellow award, the Donald E. and Delia B. Baxter Foundation, and the Child Health Research Institute.

Source: Jackie Flynn forStanford University

Read more:
Nanostraw doesn’t destroy cells as it samples their guts – Futurity – Futurity: Research News

Nanostraws Sample Cells Without Damage – R & D Magazine

Tiny nanostraws may offer a glimpse into a cells contents without causing any damage to the cell.

The nanostraws were developed by researchers at Stanford University, who devised a method of sampling cell contents without disrupting its natural processes, which is a staple of current cell sampling methods.

The new method relies on tiny tubes 600 times smaller than a stand of hair that allow researchers to sample a single cell at a time. The nanostraws are able to penetrate a cells outer membrane without damaging it and draw out proteins and genetic material from the cells salty interior.

It’s like a blood draw for the cell, Nicholas Melosh, an associate professor of materials science and engineering and senior author on a paper, said in a statement.

According to Melosh, this technique will significantly impact the understanding of cell development and could yield much safer and effective medical therapies because it allows for long term, non-destructive monitoring.

What we hope to do, using this technology, is to watch as these cells change over time and be able to infer how different environmental conditions and ‘chemical cocktails’ influence their developmentto help optimize the therapy process, he said.

If researchers gain a better grasp on how a cell works they can address those processes directly.

For stem cells, we know that they can turn into many other cell types but we do not know the evolutionhow do they go from stem cells to, say, cardiac cells? Yuhong Cao, a graduate student and first author on the paper, said in a statement. This sampling technique will give us a clearer idea of how it’s done.

A benefit of the sampling method is it could inform cancer treatments and answer questions about why some cancer cells are resistant to chemotherapy while others are not.

With chemotherapy, there are always cells that are resistant, Cao said. If we can follow the intercellular mechanism of the surviving cells, we can know, genetically, its response to the drug.

The nanostraws are grown in a small sampling platform designed to mimic biology called the Nanostraw Extraction (NEX) sampling system.

Cells divide and change over time, with thousands of chemical reactions occurring within each cell every day, which makes it difficult to truly understand the inner workings of cells.

Currently, scientists use a method of cell sampling called lysing, which ruptures the cell. However, once a cell is destroyed it cannot be sampled from again.

Cells in our bodies are connected by a system of gates through which they send each other nutrients and molecules.

Melosh was inspired to develop the new system when he observed the intercellular gates after he was trying to determine a non-destructive way of delivering substances, including DNA or medicines, inside cells.

The new sampling system is the reverse of that process, as scientists are able to observe whats happening within a cell.

When the research team compared their cells samples from the NEX with cell samples taken by breaking the cells open, they found that 95 percent of the samples were congruous.

The team also found that when they sampled from a group of cells day after day, certain molecules that should be present at constant levels remained the same, which indicated that their sampling accurately reflected the cells interior.

The team not only sampled generic cell lines but also with human heart tissue and brain cells grown from stem cells and in each case the nanostraw sampling reflected the same cellular contents as lysing the cells.

The study was published in the Proceedings of the National Academy of Sciences of the United States of America.

Continued here:
Nanostraws Sample Cells Without Damage – R & D Magazine

Less Acute MI, More HF: European Task Force Shifts Support for ‘Overhyped’ Cell Therapy Research – TCTMD

The decade-old excitement surrounding the potential for autologous cell therapy to treat cardiovascular disease may have fizzled into futility for many clinicians. But according to a new European consensus document, its possible this technology will yet find a way into future practice .

One of the problems the field has faced is that people got super excited 10 years ago because it was overhyped, and essentially . . . it led to the expectation that every time we presented [something] at clinical meetings, the field would move forward. And of course that wasnt the case, chair of the European Society of Cardiology stem cell task force and lead author Anthony Mathur, MD (St Bartholomews Hospital West Smithfield, London, England), told TCTMD.

The reason why I think people have run out of steam on this one is that theyve shared the 10-year journey with us. Anthony Mathur

Mathur contrasted the story of cell therapy to that of drug or device development, which is usually kept private until promising phase III data are available to support its routine use. What we’ve done is weve exposed the clinical and scientific community to a journey that in pharma we just wouldn’t see as clinicians, he said. The reason why I think people have run out of steam on this one is that theyve shared the 10-year journey with us.

The document, which appeared online February 15, 2017, ahead of print in the European Heart Journal, was written as an update to a slightly more optimistic statement from the same task force published in 2006.

Of all of the recommendations that the original document made, very few have borne fruit. For example, the task force suggested the completion of a randomized trial for the use of autologous stem cells to treat acute MI patients presenting after more than 12 hours or who fail to respond to therapy. A trial such as this has not been undertaken and likely wont happen, given that primary angioplasty practice in Europe and the United States has revolutionized the treatment of acute MI and drastically lowered mortality, Mathur said. Any new method of treating acute MI will find it really tough to demonstrate an improvement unless its a complete game changer.

Since these patients may well develop heart failure, for which chronic cell therapy strategies are under development, research efforts should refocus there for now, the task force writes.

However, they stand by one 2006 recommendation for a randomized trial of autologous cells in acute MI patients presenting within 12 hours and treated with immediate revascularization. The ongoing phase III BAMI trial, undertaken by members of this task force including Mathur, will study just that but results are not expected for several years. Once these results are available, it will be time to either draw a line under it or ask for regulatory approval, but it’s sort of pointless to keep rehashing the whole thing and going back asking the same question, Mathur said.

Careful But Hopeful

Looking back, Mathur said that the trajectory of cell therapy in cardiology has taught him to be self-critical and very careful about what we say, and to understand that it is okay to stop doing certain things that were once thought to be appropriate. Also, because those involved in translational research lack the tools that give us an evidence or an idea of the signal that we should expect in larger clinical trials, [a] lot of what weve come across is potentially unexpected. Unfortunately, it also means . . . weve probably disregarded areas of research based on the signals we haven’t seen in smaller studies simply because, in a way, the tools we have arent sensitive enough to pick it up, he said.

If there is any biological signal found in a phase II study, Mathur stressed the importance of trying to complete a phase III study in order to unlock these unexpected kernels.

Far from being defeated, he said he is hopeful that cell therapy will pan out in some way for cardiac patients. Whether cell therapy worked or not, it’s all about the amazing stories and how it changed people’s lives seemingly for the better. So thats something thats difficult to drop, Mathur said. We have seen a signal for patients in heart failure in which there seems to be some sort of benefit. And some might say its purely psychological. Fine, but these people who were told there was nothing else that could be done got better.

Read more:
Less Acute MI, More HF: European Task Force Shifts Support for ‘Overhyped’ Cell Therapy Research – TCTMD

Researchers implicate suspect in heart disease linked to diabetes – Medical Xpress

February 21, 2017 by Mark Derewicz Top Row: Heart arteries in normal mice, diabetic mice, and normal mice with deleted IRS-1 gene. Bottom row: when artery is wounded, diabetic mice with less IRS-1 and normal mice with deleted IRS-1 gene show much greater blockage due to over-proliferation of smooth muscle cells. Credit: Clemmons Lab, UNC School of Medicine

People with diabetes are at high risk of developing heart disease. Despite knowing this, scientists have struggled to trace the specific biology behind that risk or find ways to intervene. Now, UNC School of Medicine researchers have hunted down a possible culprit – a protein called IRS-1, which is crucial for the smooth muscle cells that make up veins and arteries.

According to a study published in the Journal of Biological Chemistry, too little of IRS-1 causes cells to revert to a “dedifferentiated” or stem-cell like state, and this may contribute to the buildup of plaque in the heart’s arteries, a condition known as atherosclerosis, which increases the risk of heart attack, stroke, and other forms of heart disease.

“When diabetes is poorly managed, your blood sugar goes up and the amount of this protein goes down, so the cells become subject to abnormal proliferation,” said senior author David R. Clemmons, MD, Sarah Graham Kenan Professor of Medicine at the UNC School of Medicine. “We need to conduct more studies, but we think this cell pathway may have significant implications for how high blood glucose leads to atherosclerosis in humans.”

The research could bring scientists one step closer to finding drugs to help stave off heart disease in people with diabetes, who are twice as likely to have heart disease or experience a stroke, as compared to people without diabetes. People with diabetes also tend to experience major cardiac events at a younger age.

The study focused on the cells that form the walls of veins and arteries, known as vascular smooth muscle cells. The main function of these cells is to contract whenever the heart beats, helping to push oxygen-rich blood to the body’s tissues. When plaque builds up along the arterial walls, these cells gradually lose their ability to contract.

In their previous work, Clemmons and colleagues discovered that diabetes can trigger an abnormal cell signaling pathway that causes vascular smooth muscle cells to proliferate, which contributes to atherosclerosis. But their attempts to correct the abnormal signaling pathway didn’t seem to completely solve the problem, leading them to suspect another factor.

In the new study, the team found that IRS-1 acts as an inhibitor of the abnormal signaling pathway thereby keeping the vascular smooth muscle cells differentiated, or specialized. In the absence of IRS-1, the cells revert to a stem-cell like state, which in turn activates the abnormal signaling pathway and promotes cell proliferation.

In people with diabetes, the presence of IRS-1 is strongly influenced by how well – or how poorly – blood sugar is kept in check. Previous studies have shown that patients who frequently or consistently have high blood sugar show dramatic reductions in IRS-1. The new study is the first to link this reduction with a predisposition for heart disease.

“The study suggests that you can’t just inhibit the abnormal signaling, which we’ve already figured out how to do,” Clemmons said. “Our work suggests you probably have to restore the normal signaling pathway, at least to some extent, in order to completely restore the cells to normal cell health, differentiation, and functioning.”

As a next step, the Clemmons lab will look for things that might stimulate the synthesis of this protein even in the presence of high blood glucose.

To prove that IRS-1 acts as a brake on the abnormal signaling pathway that leads to cell proliferation, the team conducted experiments in three different types of mice: healthy mice, diabetic mice, and nondiabetic mice that were genetically engineered to produce no IRS-1. The scientists made a small incision in the blood vessels of the animals and then watched to see how the vascular smooth muscle cells reacted. In healthy mice, the incision stimulated wound healing but little cellular proliferation. In both the diabetic animals and the nondiabetic IRS-1 deficient animals, the researchers observed a marked increase in abnormal cellular proliferation.

The findings suggest that it may be possible to counteract the deleterious effects of high blood sugar on atherosclerosis by developing drugs that boost IRS-1.

Clemmons said the activities of IRS-1 might also play a role in other diabetes complications, such as eye and kidney disease. The researchers plan to study those potential links.

Explore further: Researchers use stem cells to regenerate the external layer of a human heart

A process using human stem cells can generate the cells that cover the external surface of a human heartepicardium cellsaccording to a multidisciplinary team of researchers.

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Why do some people get Type 2 diabetes, while others who live the same lifestyle never do?

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I was diagnosed with type 2 Diabetes and put on Metformin on June 26th, 2016. I started the ADA diet and followed it 100% for a few weeks and could not get my blood sugar to go below 140. Finally i began to panic and called my doctor, he told me to get used to it. He said I would be on metformin my whole life and eventually insulin. At that point i knew something wasn’t right and began to do a lot of research. On August 13th I found Lisa’s diabetes story (google ” HOW EVER I FREED MYSELF FROM THE DIABETES ” ) I read that article from end to end because everything the writer was saying made absolute sense. I started the diet that day and the next morning my blood sugar was down to 100 and now i have a fasting blood sugar between Mid 70’s and the 80’s. My doctor took me off the metformin after just three week of being on this lifestyle change. I have lost over 30 pounds and 6+ inches around my waist in a month

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Researchers implicate suspect in heart disease linked to diabetes – Medical Xpress

CardioBrief: After Yet Another Failure, Stem Cell Leaders Double Down – MedPage Today

Despite an unrelieved history of negative trials, stem cell leaders continue to defend their field.

In response to the failure of yet another cardiac stem clinical trial, Roberto Bolli, a prominent leader in the field, argued that it’s time for a “paradigm shift” in the field. We need more stem cell therapy, not less, he argued, perhaps counterintuitively, in an article in Circulation Research. Bolli, who is also the editor-in-chief of the journal, proposed the novel position that the single dose of cells used in virtually all previous stem cell therapy trials should be replaced down the road with repeated doses of stem cells.

It is an understatement to say that cardiac stem cell therapy has not lived up to earlier expectations and hype. As Bolli himself wrote in his article, “a rising tide of skepticism has bedeviled the field” and “enthusiasm for cell therapy has been dampened by the inconsistent, modest, borderline, or undetectable benefits reported in clinical trials.” He noted that “no cell-based therapy is close to being approved for heart disease” and “leading some critics even to question whether clinical studies should continue.”

Bolli rejected this grim view of the field. His response was to double down on stem cells, writing that “just as most pharmacologic agents are ineffective when given once but can be highly effective when given repeatedly, so a cell product may be ineffective, or modestly effective, when given as a single treatment, but may turn out to be quite efficacious if given repeatedly. This concept constitutes a major paradigm shift, with potentially vast implications for the entire field of reparative medicine.”

Bolli wrote that the single-dose model was based on the initial hope that “transplanted cells would engraft and differentiate into cardiac cells.” As it turns out, “we now know that the vast majority of transplanted cells disappear quickly, regardless of the number that is administered.”

The new concept is that “transplanted cells impart their salubrious effects not by engrafting, but by releasing EVs [extracellular vesicle](or other paracrine factors) into the surrounding tissue.” However, as critics have pointed out, there is no consensus on the existence of this “salubrious effect,” since these have only emerged in secondary or post hoc analyses. Further, there is no agreement or detailed elucidation of a biologically-plausible mechanism for this effect.

One reason multiple dosing hasn’t been attempted in the past, even in rodents, is “because the stress of repeated thoracotomies is associated with prohibitively high mortality and because most Animal Committees would not approve such protocols,” Bolli stated. Now that cells can be delivered percutaneously, Bolli argued, it may be feasible to study multiple doses in animals and in humans.

Bolli didn’t dwell on it, but one implication here is that human trials would require patients to undergo multiple percutaneous procedures. But this would almost certainly raise a whole host of new issues. What are the ethical issues of performing multiple invasive procedures on patients of an entirely unproven therapy? Further, even if it proved successful, what would be the cost of multiple invasive procedures requiring expensive cell isolation and preparation techniques?

Circling The Wagons

Bolli’s paper accompanied the publication in Circulation Research of PreSERVE-AMI, a highly anticipated (in the stem cell field, at least) trial “to evaluate the safety and bioactivity of autologous CD34+ cell (CLBS10) intracoronary infusion in patients with left ventricular dysfunction post STEMI.” To cut to the chase, no safety issues emerged but there was no difference in the primary endpoint of the trial, which was change in resting myocardial perfusion over 6 months.

But, like Bolli, the trial investigators managed to find a ray of hope. There were three deaths in the trial, all in the control arm. And, in a secondary analysis, “when adjusted for time of ischemia, a consistently favorable cell dosedependent effect was observed in the change in left ventricular ejection fraction and infarct size, and the duration of time subjects was alive and out of hospital (P=0.05).”

These findings led the investigators to conclude that the trial “provides evidence supporting safety and potential efficacy.” This rosy view of the trial gained support in a second editorial about the trial, written by a group of stem cell researchers at the University of Miami led by another prominent leader in the field, Joshua Hare. Despite the main results, “the positive post hoc analyses from this trial will undoubtedly lead to important new hypotheses to be tested in future trials,” they wrote.

Searching For The Pony

Bolli’s proposal can be viewed as a desperate Hail Mary effort to salvage a dying — or, some would say, already dead — field of research. But if all the failures are due to single dosing then the entire fields gets a do-over.

“If one dose is not sufficient to evaluate efficacy, then the conclusions of these studies, particularly those that have reported ‘negative’ results, could be questioned because the benefits of the treatment may have been underestimated or even completely overlooked,” he wrote. “Disquietingly, an entire body of literature (almost all studies conducted to date) may have to be reconsidered.” But, of course, there’s no concrete evidence that repeated doses will result in a different outcome.

Bolli wondered if the negative results were “because the product did not work or because the treatment protocol was inadequate?” But Bolli, along with the trial investigators and the other editorialists, failed to seriously consider the more plausible explanation that the repeated and consistent failures indicate that stem cell therapy is just not ready for prime time. These researchers are like the boy in the proverbial stable, frantically shovelling out an enormous pile of manure. When asked why he’s working so hard he explains, “There must be a pony here somewhere!”

Perhaps it’s about time for cardiac stem cell researchers to admit there’s no pony.

Previous Stem Cell Stories:

2017-02-20T16:00:00-0500

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CardioBrief: After Yet Another Failure, Stem Cell Leaders Double Down – MedPage Today

Minuscule nanostraws sample a cell’s contents without damage … – Stanford University News

Cells within our bodies divide and change over time, with thousands of chemical reactions occurring within each cell daily. This makes it difficult for scientists to understand whats happening inside. Now, tiny nanostraws developed by Stanford researchers offer a method of sampling cell contents without disrupting its natural processes.

Nicholas Melosh, associate professor of materials science and engineering, developed a new, non-destructive system for sampling cells with nanoscale straws. The system could help uncover mysteries about how cells function. (Image credit: L.A. Cicero)

A problem with the current method of cell sampling, called lysing, is that it ruptures the cell. Once the cell is destroyed, it cant be sampled from again. This new sampling system relies on tiny tubes 600 times smaller than a strand of hair that allow researchers to sample a single cell at a time. The nanostraws penetrate a cells outer membrane, without damaging it, and draw out proteins and genetic material from the cells salty interior.

Its like a blood draw for the cell, said Nicholas Melosh, an associate professor of materials science and engineering and senior author on a paper describing the work published recently in Proceedings of the National Academy of Sciences.

The nanostraw sampling technique, according to Melosh, will significantly impact our understanding of cell development and could lead to much safer and effective medical therapies because the technique allows for long term, non-destructive monitoring.

What we hope to do, using this technology, is to watch as these cells change over time and be able to infer how different environmental conditions and chemical cocktails influence their development to help optimize the therapy process, Melosh said.

If researchers can fully understand how a cell works, then they can develop treatments that will address those processes directly. For example, in the case of stem cells, researchers are uncovering ways of growing entire, patient-specific organs. The trick is, scientists dont really know how stem cells develop.

For stem cells, we know that they can turn into many other cell types, but we do not know the evolution how do they go from stem cells to, say, cardiac cells? There is always a mystery. This sampling technique will give us a clearer idea of how its done, said Yuhong Cao, a graduate student and first author on the paper.

The sampling technique could also inform cancer treatments and answer questions about why some cancer cells are resistant to chemotherapy while others are not.

With chemotherapy, there are always cells that are resistant, said Cao. If we can follow the intercellular mechanism of the surviving cells, we can know, genetically, its response to the drug.

The sampling platform on which the nanostraws are grown is tiny about the size of a gumball. Its called the Nanostraw Extraction (NEX) sampling system, and it was designed to mimic biology itself.

In our bodies, cells are connected by a system of gates through which they send each other nutrients and molecules, like rooms in a house connected by doorways. These intercellular gates, called gap junctions, are what inspired Melosh six years ago, when he was trying to determine a non-destructive way of delivering substances, like DNA or medicines, inside cells. The new NEX sampling system is the reverse, observing whats happening within rather than delivering something new.

Its a super exciting time for nanotechnology, Melosh said. Were really getting to a scale where what we can make controllably is the same size as biological systems.

Building the NEX sampling system took years to perfect. Not only did Melosh and his team need to ensure cell sampling with this method was possible, they needed to see that the samples were actually a reliable measure of the cell content, and that samples, when taken over time, remained consistent.

When the team compared their cell samples from the NEX with cell samples taken by breaking the cells open, they found that 90 percent of the samples were congruous. Meloshs team also found that when they sampled from a group of cells day after day, certain molecules that should be present at constant levels remained the same, indicating that their sampling accurately reflected the cells interior.

With help from collaborators Sergiu P. Pasca, assistant professor of psychiatry and behavioral sciences, and Joseph Wu, professor of radiology, Melosh and co-workers tested the NEX sampling method not only with generic cell lines, but also with human heart tissue and brain cells grown from stem cells. In each case, the nanostraw sampling reflected the same cellular contents as lysing the cells.

The goal of developing this technology, according to Melosh, was to make an impact in medical biology by providing a platform that any lab could build. Only a few labs across the globe, so far, are employing nanostraws in cellular research, but Melosh expects that number to grow dramatically.

We want as many people to use this technology as possible, he said. Were trying to help advance science and technology to benefit mankind.

Melosh is also a professor in the photon science directorate at SLAC National Accelerator Laboratory, a member of Stanford Bio-X, the Child Health Research Institute, the Stanford Neurosciences Institute, Stanford ChEM-H and the Precourt Institute for Energy. Wu is also the Simon H. Stertzer, MD, Professor; he is director of the Stanford Cardiovascular Institute and a member of Stanford Bio-X, the Child Health Research Institute, Stanford ChEM-H and the Stanford Cancer Institute. Pasca is also a member of Stanford Bio-X, the Child Health Research Institute, the Stanford Neurosciences Institute and Stanford ChEM-H.

The work was funded by the National Institute of Standards and Technology, the Knut and Alice Wallenberg Foundation, the National Institutes of Health, Stanford Bio-X, the Progenitor Cell Biology Consortium, the National Institute of Mental Health, an MQ Fellow award, the Donald E. and Delia B. Baxter Foundation and the Child Health Research Institute.

Original post:
Minuscule nanostraws sample a cell’s contents without damage … – Stanford University News

Cardiac Muscle Cells Create Living Diode – Controlled Environments Magazine

Scientists are one step closer to mimicking the way biological systems interact and process information in the body a vital step toward developing new forms of biorobotics and novel treatment approaches for several muscle-related health problems such as muscular degenerative disorders, arrhythmia, and limb loss.

Using cardiac muscle cells and cardiac fibroblasts cells found in connective heart tissue researchers at the University of Notre Dame have created a living diode, which can be used for cell-based information processing, according to a recent study in Advanced Biosystems. Bioengineers created the muscle-based circuitry through a novel, self-forming, micro patterning approach.

Using muscle cells opens the door to functional, biological structures or computational tissues that would allow an organ to control and direct mechanical devices in the body. The design arranges the two types of cells in a rectangular pattern, separating excitable cells from nonexcitable cells, allowing the team to transduce electrical signals unidirectionally and achieve a diode function using living cells. In addition to the diode-like function, the natural pacing ability of the muscle cells allowed Pinar Zorlutuna, assistant professor of aerospace and mechanical engineering, and her team to pass along information embedded in the electrical signals by modulating the frequency of the cells electrical activity. Zorlutunas research was funded by the National Science Foundation.

Muscle cells have the unique ability to respond to external signals while being connected to fibroblasts internally through intercellular junctions. By combining these two cell types, we have the ability to initiate, amplify and propagate signals directionally, says Zorlutuna, who is also director of the Tissue Engineering Laboratory at the university. The success of these muscle-cell diodes offers a path toward linking such cell-based circuitry to a living system and creating functional control units for biomedical engineering applications such as bioactuators or biosensors.

The teams work presents a new option in biocomputing, which has focused primarily on using gene circuitries of genetically modified single-cells or neuronal networks doped with chemical additives to create information processing systems. The single-cell options are slower to process information since they rely on chemical processes, and neuronal-based approaches can misfire signals, firing backward up to 10 percent of the time.

Zorlutuna explores biomimetic environments in order to understand and control cell behavior. She also studies cell-cell and cell-environment interactions through tissue and genetic engineering, and micro- and nanotechnology at the Notre Dame Center for Nano Science and Technology. She is a researcher at the Universitys Center for Stem Cells and Regenerative Medicine and the Harper Cancer Research Institute.

Source: University of Notre Dame

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Cardiac Muscle Cells Create Living Diode – Controlled Environments Magazine

Scientists create scorecard index for heart-damaging chemo drugs – Medical Xpress

February 15, 2017 A single human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM). Cells such as these were used to assess tyrosine kinase inhibitors for cardiotoxicity in a high-throughput fashion. Credit: Dr. Arun Sharma at Dr. Joseph Wus laboratory at Stanford University

Researchers at the Stanford University School of Medicine used heart muscle cells made from stem cells to rank commonly used chemotherapy drugs based on their likelihood of causing lasting heart damage in patients.

Drugs known as tyrosine kinase inhibitors can be an effective treatment for many types of cancers, but they also have severe and sometimes fatal side effects. Using lab-grown heart cells, Stanford researchers were able to assess the drugs’ various effects on heart muscle cells, including whether the cells survived, were able to beat rhythmically and effectively, responded appropriately to electrophysiological signals and communicated with one another.

The researchers found that their assay can accurately identify those tyrosine kinase inhibitors already known to be the most dangerous in patients. In the future, they believe their system may prove useful in the early stages of drug development to screen new compounds for cardiotoxicity.

“This type of study represents a critical step forward from the usual process running from initial drug discovery and clinical trials in human patients,” said Joseph Wu, MD, PhD, director of the Stanford Cardiovascular Institute and a professor of cardiovascular medicine and of radiology. “It will help pharmaceutical companies better focus their efforts on developing safer drugs, and it will provide patients more effective drugs with fewer side effects.”

A paper describing the research will be published Feb. 15 in Science Translational Medicine. Wu, who holds the Simon H. Stertzer Professorship, is the senior author. Former graduate student Arun Sharma, PhD, is the lead author.

‘Multiple measurements’

“We used multiple measurements to accurately predict which of the tyrosine kinase inhibitors were the most cardiotoxic,” said Sharma. “The drugs with the lowest safety indices in our study were also those identified by the Food and Drug Administration as the most cardiotoxic to patients. Other drugs that are not as cardiotoxic performed much better in our assays.”

Validating the researchers’ cardiac-safety test on drugs with extensive clinical track records is necessary before the assay can be used to predict with confidence the likely clinical outcomes of drugs still under development.

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Sharma, Wu and their colleagues created heart muscle cells called cardiomyocytes from induced pluripotent stem cells, or iPS cells, from 11 healthy people and two people with kidney cancer. They grew the lab-made cardiomyocytes in a dish and tested the effects of 21 commonly used tyrosine kinase inhibitors on the cells.

They found that treatment with drug levels equivalent to those taken by patients often caused the cells to beat irregularly and begin to die. The cells also displayed differences in the electrophysiological signaling that controls their contraction. The researchers used these and other measurements to develop a cardiac safety index for each drug.

They found that those drugs known to be particularly dangerous to heart function, such as nilotinib, which is approved for the treatment of chronic myelogenous leukemia, and vandetanib, which is approved for the treatment of some types of thyroid cancer, also had the lowest safety indices based on the assay; conversely, those known to be better tolerated by patients ranked higher on their safety index. Prescribing information for both nilotinib and vandetanib contains warnings from the FDA about the drugs’ potential cardiotoxicity.

An activity increase in an insulin responsive pathway

Six of the 21 tyrosine kinase inhibitors tested were assigned cardiac safety indices at or below 0.1the threshold limit at which the researchers designated a drug highly cardiotoxic. Three of these six are known to inhibit the same two signaling pathways: VEGFR2 and PDGFR. The researchers noticed that cells treated with these three drugs ramped up the activity of a cellular signaling pathway that responds to insulin or IGF1, an insulinlike growth factor.

This discovery, coupled with the fact that treatment with insulin or IGF1 is known to enhance heart function during adverse cardiac events such as heart attacks, led the researchers to experiment further. They found that exposing the cells to insulin or IGF1 made it less likely they would die due to tyrosine kinase inhibitors blocking the VEGFR2 and PDGFR pathways. Although more research is needed, these findings suggest it may be possible to alleviate some of the heart damage in patients receiving these chemotherapies.

The current study mirrors another by Wu’s lab that was published in April 2016 in Nature Medicine. That research focused on the toxic effect of a chemotherapy drug called doxorubicin on iPS cell-derived cardiomyocytes. Doxorubicin, which indiscriminately kills any replicating cells, is increasingly being replaced by more targeted, cancer-specific therapies such as the tyrosine kinase inhibitors tested in the current study.

“The switch from doxorubicin is a result of the paradigm shift in cancer treatment to personalized, precise treatment as emphasized by President Obama’s 2015 Precision Medicine Initiative,” said Wu. “Moving even further, we’re discovering that many tyrosine kinase inhibitors are themselves significantly cardiotoxic, and some have been withdrawn from the market. There is a critical need for a way to ‘safety test’ all drugs earlier in development before they are administered to patients. Our drug safety index is a step in that direction.”

Explore further: Stem cell-based screening methods may predict heart-related side effects of drugs

More information: “High-throughput screening of tyrosine kinase inhibitor cardiotoxicity with human induced pluripotent stem cells,” Science Translational Medicine, stm.sciencemag.org/lookup/doi/10.1126/scitranslmed.aaf2584

Coaxing stem cells from patients to become heart cells may help clinicians personalize drug treatments and prevent heart-related toxicity.

Heart muscle cells made from induced pluripotent stem cells faithfully mirror the expression patterns of key genes in the donor’s native heart tissue, according to researchers at the Stanford University School of Medicine. …

Researchers at Moffitt Cancer Center have determined that chronic myeloid leukemia patients who are treated with a class of oral chemotherapy drugs known as a tyrosine kinase inhibitors have significant side effects and quality-of-life …

Some cancers can be effectively treated with drugs inhibiting proteins known as receptor tyrosine kinases, but not those cancers caused by mutations in the KRAS gene. A team of researchers led by Jeffrey Engelman, at Massachusetts …

Acute myeloid leukemia (AML) is a cancer of myeloid stem cells that develops in both adult and pediatric populations. Mutations that cause hyperactivation of the FMS-like tyrosine kinase 3 (FLT3) are commonly found in AML, …

Fat cells are not simply big blobs of lipid quietly standingby in the bodyinstead, they send out hormones and other signaling proteins that affect many types of tissues. Scientists at Joslin Diabetes Center now have identified …

Researchers at the Stanford University School of Medicine used heart muscle cells made from stem cells to rank commonly used chemotherapy drugs based on their likelihood of causing lasting heart damage in patients.

Research published today in Nature from scientists at Huntsman Cancer Institute (HCI) at the University of Utah shows how epithelial cells naturally turn over, maintaining constant numbers between cell division and cell death.

Scientists are working to understand the mechanisms that make weight loss so complicated. Exercise burns calories, of course, but scientists are also looking at how the body burns more energy to stay warm in cold temperatures.

Biologists have known for decades that enduring a short period of mild stress makes simple organisms and human cells better able to survive additional stress later in life. Now, scientists at Sanford Burnham Prebys Medical …

A puzzling question has lurked behind SMA (spinal muscular atrophy), the leading genetic cause of death in infants.

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Original post:
Scientists create scorecard index for heart-damaging chemo drugs – Medical Xpress

Researchers develop ‘living diode’ using cardiac muscle cells – Science Daily

Scientists are one step closer to mimicking the way biological systems interact and process information in the body — a vital step toward developing new forms of biorobotics and novel treatment approaches for several muscle-related health problems such as muscular degenerative disorders, arrhythmia and limb loss.

Using cardiac muscle cells and cardiac fibroblasts — cells found in connective heart tissue — researchers at the University of Notre Dame have created a “living diode,” which can be used for cell-based information processing, according to a recent study in Advanced Biosystems. Bioengineers created the muscle-based circuitry through a novel, self-forming, micro patterning approach.

Using muscle cells opens the door to functional, biological structures or “computational tissues” that would allow an organ to control and direct mechanical devices in the body. The design arranges the two types of cells in a rectangular pattern, separating excitable cells from nonexcitable cells, allowing the team to transduce electrical signals unidirectionally and achieve a diode function using living cells. In addition to the diode-like function, the natural pacing ability of the muscle cells allowed Pinar Zorlutuna, assistant professor of aerospace and mechanical engineering, and her team to pass along information embedded in the electrical signals by modulating the frequency of the cells’ electrical activity. Zorlutuna’s research was funded by the National Science Foundation.

“Muscle cells have the unique ability to respond to external signals while being connected to fibroblasts internally through intercellular junctions. By combining these two cell types, we have the ability to initiate, amplify and propagate signals directionally,” said Zorlutuna, who is also director of the Tissue Engineering Laboratory at the university. “The success of these muscle-cell diodes offers a path toward linking such cell-based circuitry to a living system — and creating functional control units for biomedical engineering applications such as bioactuators or biosensors.”

The team’s work presents a new option in biocomputing, which has focused primarily on using gene circuitries of genetically modified single-cells or neuronal networks doped with chemical additives to create information processing systems. The single-cell options are slower to process information since they relay on chemical processes, and neuronal-based approaches can misfire signals, firing backward up to 10 percent of the time.

Zorlutuna explores biomimetic environments in order to understand and control cell behavior. She also studies cell-cell and cell-environment interactions through tissue and genetic engineering, and micro- and nanotechnology at the Notre Dame Center for Nano Science and Technology. She is a researcher at the University’s Center for Stem Cells and Regenerative Medicine and the Harper Cancer Research Institute.

Story Source:

Materials provided by University of Notre Dame. Note: Content may be edited for style and length.

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Researchers develop ‘living diode’ using cardiac muscle cells – Science Daily

VistaGen Therapeutics Reports Fiscal Third Quarter 2017 Financial … – Yahoo Finance

SOUTH SAN FRANCISCO, CA–(Marketwired – February 13, 2017) – VistaGen Therapeutics Inc. (VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, today reported financial results for the third quarter of fiscal 2017 ended December 31, 2016.

The Company also provided a corporate update, including anticipated milestones for AV-101, its new generation, orally available CNS prodrug candidate in Phase 2 development, initially for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies approved by the U.S. Food and Drug Administration (FDA).

“We are excited about our progress during the last quarter, with several key advances related to our MDD-focused programs for AV-101, as well as potential regenerative medicine and drug rescue applications of our cardiac stem cell technology. Following productive discussions with the FDA last quarter, our team and key advisors have been working diligently to complete the diverse regulatory and technical activities necessary to support the planned launch of our Phase 2b study of AV-101 next quarter, a study we believe has game-changing potential for the millions of patients who battle MDD every day with inadequate therapies,” commented Shawn Singh, Chief Executive Officer of VistaGen. “Also, our recent sublicense agreement with BlueRock Therapeutics was an important advance in our cardiac stem cell program while we remain primarily focused on our Phase 2 programs for AV-101. With potentially catalytic milestones in the coming quarters, we believe we are poised to unlock significant value for our shareholders throughout 2017,” added Mr. Singh.

Recent Corporate Highlights:

The U.S. National Institute of Mental Health (NIMH) is currently conducting and fully funding a 20 to 25-patient Phase 2a study of AV-101 as a monotherapy for treatment-resistant MDD under VistaGen’s Cooperative Research and Development Agreement (CRADA) with the NIMH (Phase 2a Study). Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH and a leading clinical expert on the use of ketamine for treatment-resistant MDD, is the Principal Investigator of the Phase 2a Study. Following recent guidance from the NIMH, the Company currently anticipates that the NIMH will complete the Phase 2a Study by the end of 2017.

VistaGen is preparing to launch a 280-patient, multi-center, double-blind, placebo controlled Phase 2b efficacy and safety study evaluating AV-101 as a new generation adjunctive treatment for MDD patients with an inadequate response to standard, FDA-approved antidepressant therapies. The Company currently anticipates commencing patient enrollment in the Phase 2b Study in the second quarter of 2017. Dr. Maurizio Fava of Harvard University Medical School will serve as the Principal Investigator of VistaGen’s AV-101 Phase 2b Study. Topline clinical results from the Phase 2b Study are currently anticipated by the end of 2018.

Dr. Mark Smith, Chief Medical Officer of VistaGen, commented, “We look forward to starting patient enrollment in our Phase 2b study of AV-101 as an adjunctive therapy in the treatment of MDD. We believe we have significantly de-risked this Phase 2b study with a clinical trial methodology that is designed to overcome the challenge of placebo effects in psychiatric clinical trials. Based on the study protocol we have designed in collaboration with key opinion leaders in depression and neuroscience, including our Principal Investigator, Dr. Fava, we expect that achieving a successful outcome of our Phase 2b study will be integral in realizing AV-101’s potential to displace atypical antipsychotics and non-drug interventions in the current depression treatment paradigm, representing a much needed treatment solution for physicians and patients, as well as an enormous opportunity for VistaGen.”

Expected Near-Term Milestones:

“The NIMH recently updated us on their timelines for the completion of the Phase 2a study of AV-101 as a monotherapy for MDD. The Phase 2a study protocol requires considerable time and dedication from both the study participants and the multi-disciplinary NIMH teams involved. Patient enrollment for the Phase 2a study remains ongoing and we currently anticipate the NIMH’s completion of the study by the end of 2017. Our top priority is to execute our plans for our Phase 2b study of AV-101 as a new generation adjunctive treatment of MDD, and we remain on track to launch that important study in the second quarter. As part of our Phase 2 program, this Phase 2b study has been specifically designed to achieve important outcomes that will be key to advancing AV-101 into a pivotal program in MDD and more broadly beyond MDD, as we continue to advance our global commercialization strategy. We are confident that our Phase 2 program is a major step forward in positioning AV-101 as a potentially transformative adjunctive treatment of MDD and other CNS disorders,” concluded Mr. Singh.

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Summary of Financial Results for the Third Quarter of Fiscal 2017 Ended December 31, 2016

Revenue

The Company recognized $1.25 million in sublicense revenue pursuant to its cardiac stem cell technology sublicense agreement with BlueRock Therapeutics, a next generation regenerative medicine company established by Bayer AG and Versant Ventures, in the third fiscal quarter ended December 31, 2016.

Research and Development Expenses

Research and development expense totaled $1.61 million for the third fiscal quarter ended December 31, 2016, compared to $806,300 for the quarter ended December 31, 2015, reflecting increasing focus on nonclinical and clinical development of AV-101 and preparations for launch of the AV-101 Phase 2b Study in the second quarter of 2017.

General and Administrative Expenses

General and administrative expense increased to $2.3 million in the third fiscal quarter ended December 31, 2016, from $1.3 million for the same period in the prior year. The increase in G&A expense is the result of increased noncash stock compensation expense attributable to option and warrant grants in the period to employees, independent members of the Company’s Board of Directors and consultants and other noncash expense related to grants of equity securities in payment of certain professional services, and a combination of corporate expenses, including investor relations and corporate development initiatives.

Net Loss

For the third fiscal quarter ended December 31, 2016, the Company reported a net loss of approximately $2.6 million, or a net loss attributable to common stockholders of $0.34 per common share, compared to a net loss of approximately $2.1 million, or a net loss attributable to common stockholders of $1.95 per common share for the same period in the prior year.

Cash and Cash Equivalents

As of December 31, 2016, the Company had approximately $5.6 million of cash, cash equivalents and short term receivables, including a $1.25 million short term sublicense fee receivable from BlueRock Therapeutics pursuant to the Company’s December 2016 technology sublicense agreement with BlueRock Therapeutics. In January 2017, the Company received the $1.25 million sublicense fee payment from BlueRock Therapeutics and currently believes it has sufficient financial resources to fund its expected operations at least through the first half of 2017, including preparation for and launch of its planned AV-101 Phase 2b Study in MDD.

About VistaGen

VistaGen Therapeutics, Inc. (VTGN), is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders. VistaGen’s lead CNS product candidate, AV-101, is a new generation oral antidepressant drug candidate in Phase 2 development. AV-101’s mechanism of action is fundamentally differentiated from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the U.S. National Institute of Mental Health (NIMH) in a Phase 2a monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 280-patient Phase 2b study of AV-101 as an adjunctive treatment for MDD patients with inadequate response to standard, FDA-approved antidepressant therapies. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the Phase 2b study. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including chronic neuropathic pain, epilepsy, Parkinson’s disease and Huntington’s disease, where modulation of the NMDAR, AMPA pathway and/or key active metabolites of AV-101 may achieve therapeutic benefit.

VistaStem Therapeutics is VistaGen’s wholly owned subsidiary focused on applying human pluripotent stem cell (hPSC) technology, internally and with third-party collaborators, to discover, rescue, develop and commercialize proprietary new chemical entities (NCEs), including small molecule NCEs with regenerative potential, for CNS and other diseases, and cellular therapies involving stem cell-derived blood, cartilage, heart and liver cells. In December 2016, VistaGen exclusively sublicensed to BlueRock Therapeutics LP, a next generation regenerative medicine company established by Bayer AG and Versant Ventures, rights to certain proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease.

For more information, please visit http://www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful launch, continuation and results of the NIMH’s Phase 2a (monotherapy) and/or the Company’s planned Phase 2b (adjunctive therapy) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the development activities described above. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

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Stem Cell Basics VI. | stemcells.nih.gov

Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically reprogrammed to an embryonic stem celllike state by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells. Although these cells meet the defining criteria for pluripotent stem cells, it is not known if iPSCs and embryonic stem cells differ in clinically significant ways. Mouse iPSCs were first reported in 2006, and human iPSCs were first reported in late 2007. Mouse iPSCs demonstrate important characteristics of pluripotent stem cells, including expressing stem cell markers, forming tumors containing cells from all three germ layers, and being able to contribute to many different tissues when injected into mouse embryos at a very early stage in development. Human iPSCs also express stem cell markers and are capable of generating cells characteristic of all three germ layers.

Although additional research is needed, iPSCs are already useful tools for drug development and modeling of diseases, and scientists hope to use them in transplantation medicine. Viruses are currently used to introduce the reprogramming factors into adult cells, and this process must be carefully controlled and tested before the technique can lead to useful treatment for humans. In animal studies, the virus used to introduce the stem cell factors sometimes causes cancers. Researchers are currently investigating non-viral delivery strategies. In any case, this breakthrough discovery has created a powerful new way to “de-differentiate” cells whose developmental fates had been previously assumed to be determined. In addition, tissues derived from iPSCs will be a nearly identical match to the cell donor and thus probably avoid rejection by the immune system. The iPSC strategy creates pluripotent stem cells that, together with studies of other types of pluripotent stem cells, will help researchers learn how to reprogram cells to repair damaged tissues in the human body.

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