Archive for the ‘Cardiac Stem Cells’ Category

Dive Brief:

While the loss of the deal has made a hole on the company's value, Capricor is looking on the bright side.

"Over the last few years, and during the term of the Janssen option period, we believe that significant value for our CAP-1002 asset has been created through the demonstration of clinical proof-of-concept to treat Duchenne muscular dystrophy (DMD) and also from the progress that has been made towards the development of a commercial-scale manufacturing process for the cells," said Linda Marbn, Capricor's president and CEO.

The company also suggested that a potential upside of the loss of the agreements is that it "resolves uncertainty concerning the scope of the license for CAP-1002 and provides Capricor the freedom to enter into new licensing and/or business development opportunities."

Although, as most investors know, it's generally a bad sign when your big pharma partner bails and, typically, hurts prospects for gaining another commercialization partner.

Capricor has faced some challenges in 2017. In February, it pulled out of an agreement with the Mayo Clinic, which included scrapping development of a Phase 2 heart failure drug, cenderitide, in order to focus on cell and exosome-based therapeutics. And then in May, it faced problems with CAP-1002 in the ALLSTAR Phase 1/2 trial. These topline results showed that CAP-1002 had only a small chance of meeting the primary endpoint of significantly reducing cardiac scarring in adults who had had a major heart attack. This resulted in a reduction in the scope of the company's options, including its workforce size.

The focus for this product, which is manufactured from donated heart tissue, is now in young men with Duchenne muscular dystrophy-associated cardiomyopathy, and the HOPE Phase 1/2 trial is ongoing. Six-month results were presented late last month at the 2017 Patient Project Muscular Dystrophy (PPMD) Annual Connect Conference, showing improved cardiac systolic wall thickening, and improved performance of upper limb in treated patients.

"We discussed potential product registration strategies for this indication at our recent meeting with the U.S. Food and Drug Administration. We expect to commence a randomized, double-blind, placebo-controlled clinical trial of repeat administrations of intravenous CAP-1002 in boys and young men with DMD in the second half of this year, subject to regulatory approval," said Marbn.

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J&J drops stem cell partner Capricor - BioPharma Dive

Among the experiments: How microgravity affects stem cells and the factors that govern stem cell activity

Santa Monica's NASA astronaut Randy Bresnik, who is making final preparations for his launch to the International Space Station later this month, will be participating in live satellite interviews from 9 to 10 a.m. EDT Friday, July 14, at the Gagarin Cosmonaut Training Center in Star City, Russia.

The interviews will air live on NASA Television and the agency's website and will be preceded at 8:30 a.m. by a video feed of highlights from Bresnik's mission training and previous spaceflight.

Bresnik will arrive at the Baikonur Cosmodrome in Kazakhstan Sunday, July 16, for final pre-launch training. He and his crewmates, cosmonaut Sergey Ryazanskiy of the Russian space agency Roscosmos and Paolo Nespoli of ESA (European Space Agency), will launch on the Russian Soyuz MS-05 spacecraft at 11:41 a.m. on July 28. They are scheduled to return to Earth in December.

Their flight plan calls for an arrival at the station about six hours after launch, where they will join Expedition 52 Commander Fyodor Yurchikhin of Roscosmos, and Flight Engineers Peggy Whitson and Jack Fischer of NASA. The crew members will continue several hundred experiments in biology, biotechnology, physical science and Earth science currently underway and scheduled to take place aboard humanity's only permanently occupied orbiting lab.

Among the experiments is Cardiac Stem Cells, which investigates how microgravity affects stem cells and the factors that govern stem cell activity, including physical and molecular changes. The Cosmic-Ray Energetics and Mass experiment is also scheduled to arrive at the station during the crew's stay and will measure the charges of cosmic rays ranging from hydrogen up through iron nuclei, over a broad energy range.

Bresnik was born in Fort Knox, Kentucky, but considers Santa Monica, California, to be his hometown.

He graduated from The Citadel in Charleston, South Carolina, and was commissioned in the Marine Corps in May 1989. NASA selected him as an astronaut in May 2004. This will be his second trip to the International Space Station and his first long-duration mission. Previously he flew aboard space shuttle Atlantis to the station in 2009.

For details about his experiences in space, follow Bresnik on social media at:

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Santa Monica's NASA Astronaut Randy Bresnik Live Interviews Before Space Station Mission - Santa monica Observed

Derek Richardson

July 3rd, 2017

The CRS-11 Dragon capsule re-enters Earths atmosphere. Photo Credit: Jack Fischer / NASA

SpaceXs CRS-11 Dragon capsule splashed down at 8:12 a.m. EDT (12:12 GMT) on July 3, 2017, in the Pacific Ocean just off the coast of Baja California after some 28 days attached to the International Space Station.

After being unberthed using the robotic Canadarm2, the craft was moved to a location some 33 feet (10 meters) below the Destiny laboratory module. It was officially released at 2:41 a.m. EDT (6:41 GMT) on July 3 by Expedition 52 astronauts Jack Fischer and Peggy Whitson of NASA.

The CRS-11 Dragon capsule is positioned for release beneath the ISS. Photo Credit: Jack Fischer / NASA

Dragons been an incredible spacecraft, Fischer said after release. I could even say it was slathered in awesome sauce. This baby has had almost no problems, which is an incredible feat considering its the first reuse of a Dragon vehicle.

The CRS-11 Dragon capsule pressure vessel was the same one used during the CRS-4 mission in 2014.

And the science weve done oh my, the science, Fischer said. Most of the 6,000 pounds [2,700 kilograms] of cargo carried was science, and almost all of the return cargo are precious samples for discoveries we cant wait to see.

Fischer explained that Dragon also brought up various external experiments too, including an external platform for science, a neutron star analyzer and an experimental solar array that was rolled out like a party horn on New Years Eve.

The science on this mission has been non-stop, and we think the scientists will be extremely happy with the volumes of data we gathered for them up here in space in our floating world-class laboratory we call home, Fischer said. For the whole SpaceX team, thank you for building such a great vehicle and for finding us some good weather today to allow us to bring home the science on time. Godspeed and fair winds, Dragon-11.

The spacecraft had originally been planned to splash down on July 2, but due to a forecast of unacceptable sea conditions at the recovery zone, mission managers decided on June 30 to postpone the capsules departure from the station.

Three separate departure burns were performed by the Dragon capsule once the robotic arm released the spacecraft. This gradually pushed the vehicle away from the outpost and outside the 656-foot (200-meter) Keep-Out Sphere (KOS).

Some five hours later, Dragon, using its Draco thrusters, performed a 10-minute de-orbit burn. Minutes after that, its trunk, which is not recoverable, was jettisoned.

Moments after being released by the ISS crew, the CRS-11 Dragon capsule begins its journey back to Earth. Photo Credit: Jack Fischer / NASA

A few minutes before splashing down, the capsule released drogue chutes to slow the capsule a bit and to keep a specific attitude for the three main parachutes to bedeployed. Once that occurred, along with a successful splashdown, it ensured a successful mission for the first re-flight of a commercial spacecraft to and from the ISS.

Now that Dragon is back on Earth and on a recovery ship, it will now be transported to the port of Los Angeles to offload time-sensitive cargo. The most notable include the Fruit Fly Lab-02 experiment, the Systemic Therapy of NELL-1 for osteoporosis study, and the Cardiac Stem Cells experiment.

The Fruit Fly Lab-02 experiment aims to understand the effects of prolonged microgravity exposure on the heart. According to NASA, because flies are small, have a well-known genetic makeup, and age rapidly, thatmakes them good models for heart function studies.

For the Systemic Therapy of NELL-1 for osteoporosis study, a group of rodents were used as models to test a drug that can rebuild bone and block additional bone density loss. It is hoped that this can help reduce bone density loss for astronauts on extended stays in space. Additionally, it can potentially help people with osteoporosis.

According to NASA, in-flight countermeasures, like exercise, can prevent bone density loss from getting worse, but nothing on Earth or in space can restore bone density.

Finally, the Cardiac Stem Cells experiment aims to analyze how microgravity affects stem cells and factors that govern stem cell activity. NASA says the study focuses on cardiac stem cell functions and has numerous biomedical and commercial applications.

The CRS-11 Dragon was launched June 3 from Kennedy Space Centers Launch Complex 39A in Florida. After a two-day rendezvous profile, the capsule was berthed to the Earth-facing port of the Harmony module on June 5.

The next Dragon mission will be CRS-12 on Aug. 10, 2017. It is unclear if this capsule will also be a pre-flown vessel.

Video courtesy of NASA

Tagged: CRS-11 Dragon Expedition 52 International Space Station Lead Stories NASA SpaceX

Derek Richardson has a degree in mass media, with an emphasis in contemporary journalism, from Washburn University in Topeka, Kansas. While at Washburn, he was the managing editor of the student run newspaper, the Washburn Review. He also has a blog about the International Space Station, called Orbital Velocity. He met with members of the SpaceFlight Insider team during the flight of a United Launch Alliance Atlas V 551 rocket with the MUOS-4 satellite. Richardson joined our team shortly thereafter. His passion for space ignited when he watched Space Shuttle Discovery launch into space Oct. 29, 1998. Today, this fervor has accelerated toward orbit and shows no signs of slowing down. After dabbling in math and engineering courses in college, he soon realized his true calling was communicating to others about space. Since joining SpaceFlight Insider in 2015, Richardson has worked to increase the quality of our content, eventually becoming our managing editor.

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Dragon splashes down in Pacific with time-critical experiments - SpaceFlight Insider

SpaceX's Dragon cargo craft splashed down in the Pacific Ocean at 8:12 a.m. EDT, west of Baja California and the recovery process is underway, marking the end of the company's eleventh contracted cargo resupply mission to the International Space Station for NASA.

Expedition 52 astronauts Jack Fischer and Peggy Whitson of NASA released the SpaceX Dragon cargo spacecraft from the International Space Station's robotic arm right on schedule, at 2:41 a.m.

A variety of technological and biological studies are returning in Dragon. The Fruit Fly Lab-02 experiment seeks to better understand the effects of prolonged exposure to microgravity on the heart.

Flies are small, with a well-known genetic make-up, and age rapidly, making them good models for heart function studies. This experiment could significantly advance understanding of how spaceflight affects the cardiovascular system and could help develop countermeasures to help astronauts.

Samples from the Systemic Therapy of NELL-1 for osteoporosis will return as part of an investigation using rodents as models to test a new drug that can both rebuild bone and block further bone loss, improving crew health.

When people and animals spend extended periods of time in space, they experience bone density loss, or osteoporosis. In-flight countermeasures, such as exercise, prevent it from getting worse, but there isn't a therapy on Earth or in space that can restore bone density.

The results from this ISS National Laboratory-sponsored investigation is built on previous research also supported by the National Institutes for Health and could lead to new drugs for treating bone density loss in millions of people on Earth.

The Cardiac Stem Cells experiment investigated how microgravity affects stem cells and the factors that govern stem cell activity. The study focuses on understanding cardiac stem cell function, which has numerous biomedical and commercial applications. Scientists will also look to apply new knowledge to the design of new stem cell therapies to treat heart disease on Earth.

The Dragon spacecraft launched June 3 on a SpaceX Falcon 9 rocket from historic Launch Complex 39A at NASA's Kennedy Space Center in Florida, and arrived at the station June 5.

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Original post:
Dragon Splashes Down to Complete Resupply Mission - Space Daily

SOUTH SAN FRANCISCO, CA--(Marketwired - June 29, 2017) - VistaGen Therapeutics Inc.(NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, today reported its financial results for its fiscal year ended March 31, 2017.

The Company also provided an update on its corporate progress, clinical status and anticipated milestones for AV-101, its orally available CNS prodrug candidate in Phase 2 development, initially as a new generation treatment for major depressive disorder (MDD).

"With a team of industry experts and a focused strategy in place, we have established a strong foundation and embarked on paths to achieve several key catalysts within the next 18 months. We anticipate our first catalyst within the next 9 months as the NIMH completes its AV-101 Phase 2 monotherapy study in MDD, a study being conducted and fully funded by the NIH. Additionally, we are working closely with the FDA and our Principal Investigator, Dr. Maurizio Fava of Harvard University Medical School, on our AV-101 Phase 2 adjunctive treatment study in MDD, which we anticipate will begin enrollment in the first quarter of 2018 and be completed by the end of 2018, with topline results available in the first quarter of 2019," commented Shawn Singh, Chief Executive Officer of VistaGen.

In addition to MDD, AV-101 may have therapeutic potential in several other CNS indications where modulation of NMDA receptors, activation of AMPA pathways and/or active metabolites of AV-101 play a key role, including for treatment of epilepsy, as a non-opioid alternative for management of neuropathic pain, and to address certain symptoms associated with Parkinson's disease and Huntington's disease.

Mr. Singh continued, "Our MDD clinical program is our top priority, and will remain so. Additionally, however, recent peer-reviewed publications suggest that AV-101 may have significant therapeutic potential as a non-opioid treatment alternative for pain management. We are also excited about AV-101's potential to reduce dyskinesia associated with standard levodopa, or L-DOPA, therapy for Parkinson's disease, based on results from previous non-clinical studies. Without diverting our priority focus on MDD, we plan to expand our AV-101 Phase 2 clinical program during the next year to include these important CNS indications with significant unmet need."

"We are also pleased to have advanced our cardiac stem cell program during fiscal 2017, through both our participation in the FDA's CiPA initiative focused on using novel human stem cell models to predict cardiac toxicity of new drug candidates long before animal and human studies, as well as our exclusive sublicense agreement with BlueRock Therapeutics, an emerging force in cardiac regenerative medicine, founded and funded by Bayer AG and Versant Ventures. Our initial revenue-generating milestone with BlueRock Therapeutics was completed during fiscal 2017. We are optimistic about this relationship's potential and the future of cardiac regenerative medicine. We believe these significant events over the past year have positioned us to create substantial value for our stakeholders in fiscal 2018 and beyond."

Potential Near-Term Milestones:

Operational Highlights During Fiscal 2017:Achievements Related to Stem Cell Technologies

Advancement of AV-101 as a Potential, Non-Opioid Treatment Alternative for Chronic Pain

Bolstered Team with Industry Experts

Intellectual Property Accomplishments

Capital Market Highlights

Financial Results for the Fiscal Year Ended March 31, 2017:

Revenue for the fiscal year ended March 31, 2017 totaled $1.25 million and was attributable to a sublicense agreement with BlueRock Therapeutics, for certain rights to the Company's proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease.

Research and development expense totaled $5.2 million for the fiscal year ended March 31, 2017, an increase of approximately 33% compared with the $3.9 million incurred for the fiscal year ended March 31, 2016. The increase in year-over-year research and development expense was attributable to increased focus on development of AV-101, including preparations to launch the Phase 2 Adjunctive Treatment Study in MDD.

General and administrative expense decreased to $6.3 million in the fiscal year ended March 31, 2017, from $13.9 million in the fiscal year ended March 31, 2016, primarily as a result of the decrease in non-cash stock compensation expense, partially offset by an increase in non-cash expense related to grants of equity securities in payment of certain professional services during fiscal 2017. Of the amounts reported, non-cash expenses, related primarily to grants or modifications of equity securities, totaled approximately $3.1 million in fiscal 2017 and $11.9 million in fiscal 2016.

Net loss for the fiscal years ended March 31, 2017 and 2016 was approximately $10.3 million and $47.2 million, respectively, the latter amount including a non-recurring, non-cash expense of approximately $26.7 million attributable to the extinguishment of approximately $15.9 million carrying value of prior indebtedness, including then-outstanding Senior Secured Convertible Notes, and conversion of such indebtedness into equity securities between May and September 2015 at a conversion price (stated value of the equity received) of $7.00 per share.

At March 31, 2017, the Company had a cash and cash equivalents balance of $2.9 million. Since late-March 2017, the Company sold units consisting of unregistered common stock and common stock warrants to accredited investors in a self-placed private placement, yielding approximately $1 million in cash proceeds to the Company.

About VistaGen

VistaGen Therapeutics, Inc. (NASDAQ: 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 in Phase 2 development, initially as a new generation oral antidepressant drug candidate for major depressive disorder (MDD). 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 2 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 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the Company's Phase 2 adjunctive treatment study. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including neuropathic pain, epilepsy, Huntington's disease, L-Dopa-induced dyskinesia associated with Parkinson's disease and other disorders where modulation of the NMDA receptors, activation of AMPA pathways 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 technology, internally and with 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.

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 financing, launch, continuation and results of the NIMH's Phase 2 (monotherapy) and/or the Company's planned Phase 2 (adjunctive therapy) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, including neuropathic pain and L-DOPA-induced dyskinesia associated with Parkinson's disease, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the Phase 2 clinical 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.

FINANCIAL TABLES FOLLOW

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VistaGen Therapeutics Reports Fiscal 2017 Financial Results and Provides Corporate Update - Markets Insider

A regenerative medicine startup led by a Mayo Clinic cardiologist is setting up shop in a downtown Rochesters Minnesota BioBusiness Center, according to newly filed city documents. The filing indicated Rion LLC, a Minnesota company registered to Dr. Atta Behfar of the Mayo Clinic Center for Regenerative Medicine, has signed a three-year lease for just over 2,000 square feet at the city-owned BioBusiness Center. The lease begins July 1. The nine-story BioBusiness Center opened in downtown Rochester in 2007 as a center for innovation in biotechnology, promoting the linkages between the researchers and practitioners at Mayo Clinic; instructors and students at the University of Minnesota Rochester, and the biotechnology business community. It houses the Mayo Clinic Business Accelerator among other tenants. Behfar is an assistant medical professor and leads a laboratory at Mayo concentrating on applying regenerative medicine the practice of using stem cells to regenerate damaged or missing tissue to prevent and cure chronic heart conditions. Specifically, his group focuses on development and use of both stem cells and protein-based therapies to reverse injury caused by lack of blood flow to the heart. The business direction of Rion, meanwhile, appears to be specifically geared toward a cutting-edge development in the field of regenerative medicine the use of extracellular vesicles (EVs) in speeding and directing the growth of regenerating tissues in the heart and elsewhere in the body. EVs, long brushed off by researchers as mere debris in the bloodstream, are membrane-enclosed spheres that break off from the surfaces of nearly all living cells when disturbed. They transport lipids, proteins and nucleic acids, and have now been found to be important players in cell-to-cell communication, influencing the behavior and even the identity of cells. Their emerging role in regenerative medicine could potentially be huge. For instance, by bioengineering them to transport protein payloads from stem cells, they can be used to signal the bodys own cells to regenerate tissue instead of transplanting the stem cells themselves, thus eliminating the chance of host immune system rejection. A patent application filed last year by Rion, Behfar, Mayo Center for Regenerative Medicine Director Dr. Andre Terzic and two other local inventors is aimed at adapting the healing properties of a specific type of EV into a unique kind of product that could have wide applications. It focuses on EVs derived from blood platelets, which are well known to stop bleeding, promote the growth of new tissues and blood vessels, relieve inflammation and provide a host of other benefits. The patent describes a system of encapsulating platelet EVs derived from human or animal blood into a platelet honey and delivering it to target areas of the body, such as damaged tissues or organs. Its purported effect is to regenerate, repair and restore damaged tissue, with possible uses including treating heart disease; healing damaged bones or joints; wound treatment; and cosmetic skin applications. A brief business description provided by Rion to Rochester city officials stated the company is focused on the delivery of cutting edge regenerative technologies to patients at low cost and in off-the-shelf fashion. Building on initial research at Mayo Clinic, Rion LLC aims to develop and bring to practice products in the space of wound healing, orthopedics and cardiac disease. The statement also added the company is an enthusiastic backer of Rochesters efforts to develop a local biotech business cluster, and is seeking to participate in the realization of the Destination Medical Center initiative.

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Mayo-Connected Regenerative Medicine Startup Inks Downtown Rochester Lease - Twin Cities Business Magazine

Expedition 52 explored the aging process in space today and measured the lighting conditions on the International Space Station. The crew is also getting spacesuits ready for an upcoming Russian spacewalk.

Flight Engineer Peggy Whitson swapped out stem cell samples today inside the Microgravity Science Glovebox for the Cardiac Stem Cells study. The experiment is researching spaceflights effect on accelerated aging and may provide a treatment for heart disease on Earth. Scientists are observing the stem cells in space to determine their role in cardiac biology and effectiveness in tissue regeneration.

Whitson also set up light meters to measure the intensity and color of new LED (light-emitting diode) light bulbs installed in the station. The data is being collected for the Lighting Effects study to determine how the new lights affect crew sleep, circadian rhythms and cognitive performance.

NASA astronaut Jack Fischer checked out Russian Orlan spacesuits with Commander Fyodor Yurchikhin this morning. The spacesuit maintenance work is doing being done ahead of a Russian spacewalk planned for later this year.

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Aging and Heart Research Lead Station Science Today - Space Fellowship

SOUTH SAN FRANCISCO, CA--(Marketwired - June 22, 2017) - VistaGen Therapeutics Inc.(NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, announced today a peer-reviewed publication in the Scandinavian Journal of Pain of two Phase 1 clinical studies of the effects of AV-101 (4-Cl-KYN), the Company's CNS prodrug candidate, as a potential non-opioid treatment for neuropathic pain. Safety data from both the single and multi-dose Phase 1 studies indicated that oral AV-101 was extremely safe and well tolerated, with no meaningful difference in adverse events (AEs) at any dose between AV-101 and placebo. Recently published statistically-significant positive results in four well-established preclinical models of pain associated with tissue inflammation and nerve injury, together with the excellent clinical safety profile, pharmacokinetic (PK) characteristics and consistent reductions in three pain measures (allodynia, mechanical and heat hyperalgesia) demonstrated by these studies, support future Phase 2 clinical studies of AV-101 as a potential new non-opioid treatment alternative for neuropathic pain.

The publication, titled "Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study: Investigation of the Safety, Pharmacokinetics, and Antihyperalgesic Activity of L-4 chlorokynurenine in Healthy Volunteers," by lead author, Mark Wallace, MD, and co-authors, Alexander White, MD, Kathy A Grako, PhD, Randal Lane, Allen (Jo) Cato, PhD and H. Ralph Snodgrass, PhD, was recently published in the Scandinavian Journal of Pain (DOI: 10.1016/j.sjpain.2017.05.004) and is available online at http://www.scandinavianjournalpain.com/article/S1877-8860(17)30128-3/fulltext.

"The excellent safety data and consistent reductions in allodynia pain and mechanical and heat hyperalgesia during the two Phase 1 clinical studies of AV-101 support our belief in its potential to treat neuropathic pain without the negative side-effects experienced with most of the drugs used today to treat pain. Additional clinical trials of AV-101 in neuropathic pain are warranted," reported Mark Wallace, MD, Distinguished Professor of Clinical Anesthesiology at the University of California, San Diego.

"The positive results published in these studies further support our belief that AV-101 has the potential to reduce pain effectively and safely, without causing burdensome side effects like gabapentin and many other neuropathic pain treatments, such as opiates, on the market today. The opioid epidemic, which stems in part from prescribing opiate analgesics for outpatient procedures, makes it imperative that we find new analgesics devoid of abuse potential. Importantly, AV-101 does not bind to opioid receptors, and yet may still have efficacy in neuropathic pain," stated Mark A. Smith, MD, PhD, Chief Medical Officer, VistaGen Therapeutics. "Additionally, a key observation from these Phase 1 studies in normal volunteers was spontaneous reports of 'feelings of well-being' in subjects exposed to AV-101, especially those in the highest dose group of 1440 mg, while none of the subjects on placebo reported any such feelings. Importantly, these feelings were NOT characterized as feeling intoxicated or psychotic as has been often reported by subjects taking ketamine for major depressive disorder. We are optimistic about AV-101's potential as a new treatment alternative for major depressive disorder, without ketamine-like side effects, and for neuropathic pain, without gabapentin-like side effects or opioid abuse potential."

Study Summary and Key Findings:

Two Phase 1 Clinical Studies -

About AV-101AV-101 (4-CI-KYN) is an oral CNS prodrug candidate in Phase 2 development in the U.S., initially as a new generation treatment for major depressive disorder (MDD). AV-101 also has broad potential utility in several other CNS indications where modulation of NMDA receptors, activation of AMPA pathways and/or key active metabolites of AV-101 may achieve therapeutic benefit, including neuropathic pain and epilepsy, as well as addressing symptoms associated with neurodegenerative diseases, such as Parkinson's disease and Huntington's disease.

AV-101 is currently being evaluated in a Phase 2 monotherapy study in MDD, a study being fully funded by the U.S. National Institute of Mental Health (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, as Principal Investigator.

VistaGen is preparing to advance AV-101 into a 180-patient, U.S. multi-center, Phase 2 adjunctive treatment study in MDD patients with an inadequate response to standard FDA-approved antidepressants, with Dr. Maurizio Fava of Harvard University as Principal Investigator.

About VistaGenVistaGen Therapeutics, Inc. (NASDAQ: 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 in Phase 2 development, initially as a new generation oral antidepressant drug candidate for major depressive disorder (MDD). 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 2 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 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the Company's Phase 2 adjunctive treatment 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, Huntington's disease, and L-Dopa-induced dyskinesias associated with Parkinson's disease and, other disorders where modulation of NMDA receptors, activation of AMPA pathways 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 technology, internally and with 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 StatementsThe 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 2 (monotherapy) and/or the Company's planned Phase 2 (adjunctive therapy) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, including neuropathic pain and L-DOPA-induced dyskinesia associated with Parkinson's disease, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the Phase 2 clinical 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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VistaGen Announces Peer-Reviewed Publication in the Scandinavian Journal of Pain Highlighting Orally-Available AV ... - Markets Insider

AsianScientist (Jun. 22, 2017) - Researchers at the Institute of Bioengineering and Nanotechnology (IBN) of the Agency for Science, Technology and Research (A*STAR) have engineered a three-dimensional heart tissue from human stem cells to test the safety and efficacy of new drugs on the heart. Their research has been published in Biofabrication.

Cardiotoxicity, which can lead to heart failure and even death, is a major cause of drug withdrawal from the market. So it is important to test as early as possible whether a newly developed drug is safe for human use. However, cardiotoxicity is difficult to predict in the early stages of drug development, said Professor Jackie Y. Ying, Executive Director at IBN.

A big part of the problem is the use of animals or animal-derived cells in preclinical cardiotoxicity studies due to the limited availability of human heart muscle cells. Substantial genetic and cardiac differences exist between animals and humans. There have been a large number of cases whereby the tests failed to detect cardiovascular toxicity when moving from animal studies to human clinical trials.

Existing screening methods based on 2D cardiac structure cannot accurately predict drug toxicity, while the currently available 3D structures for screening are difficult to fabricate in the quantities needed for commercial application.

To solve this problem, the IBN research team fabricated their 3D heart tissue from cellular self-assembly of heart muscle cells grown from human induced pluripotent stem cells. They also developed a fluorescence labelling technology to monitor changes in beating rate using a real-time video recording system.

The new heart tissue exhibited more cardiac-specific genes, stronger contraction and higher beating rate compared to cells in a 2D structure.

Using the 3D heart tissue, we were able to correctly predict cardiotoxic effects based on changes in the beating rate, even when these were not detected by conventional tests. The method is simple and suitable for large-scale assessment of drug side effects. It could also be used to design personalized therapy using a patients own cells, said lead researcher Dr. Andrew Wan, who is Team Leader and Principal Research Scientist at IBN.

The researchers have filed a patent on their human heart tissue model, and hope to work with clinicians and pharmaceutical companies to bring this technology to market.

The article can be found at: Lu et al. (2017) Engineering a Functional Three-Dimensional Human Cardiac Tissue Model for Drug Toxicity Screening.

Source: A*STAR; Photo: Shutterstock. Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

Read more:
Testing For Cardiotoxicity In 3D - Asian Scientist Magazine

A new study at Tel Aviv University shows that stem cell therapy, one of the few treatments available to patients with severe and end-stage heart failure, can actually harm them unless it is done differently.

We concluded that stem cells used in cardiac therapy should be drawn from healthy donors or be better genetically engineered for the patient, said lead researcher Jonathan Leor of the universitys Sackler Faculty of Medicine and Sheba Medical Center.

Doctors use tissue or adult stem cells to replace damaged tissue, which encourages regeneration of blood vessel cells and new heart muscle tissue. But cardiac stem cells from a diseased heart can lead to a toxic interaction via a molecular pathway between the heart and the immune system, the study found.

We found that, contrary to popular belief, tissue stem cells derived from sick hearts do not contribute to heart healing after injury, Leor said. Furthermore, we found that these cells are affected by the inflammatory environment and develop inflammatory properties. The affected stem cells may even exacerbate damage to the already diseased heart muscle.

[Read the fully study here (behind paywall)]

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Study says some stem cells dangerous for heart patients

See the article here:
Stem cell therapy relying on patient's own unhealthy heart may be dangerous - Genetic Literacy Project

Here we have compiled a list of several clinics offering stem cell treatments. Please note that the "conditions treated" refers to the conditions that THEY claim to treat. Most, if not all, stem cell treatments (except hematopoietic stem cell transplantation) aren't FDA approved, meaning that they haven't been clincally tested for safety or efficacy. Please be aware that receiving an unapproved medical treatment isrisky and may cause serious complications and possibly death.

It was only a few years ago when Europe's most popular stem cell clinic (XCell-center) was forced to close after one of the treatments caused the death of a boy. In the past, we have also covered the case of a woman that had serious adverse effects following an unapproved cosmetic stem cell treatment(facelift).

We have not included clinics offering hematopoietic stem cell transplantation, as this treatment is medically approved and offered virtually in any country that has an above the average hospital.

The stem cell clinics are categorised by alphabetical order. We are not paid by any of them and we have listed them for your ease. We have probably missed a few ones, feel free to leave a comment and we will add them asap.

Stem cell clinics list

Beijing Puhua International Hospital

Conditions Treated:Diabetes, Epilepsy, Stroke, Ataxia, Spinal Cord Injuries, Parkinson's Disease, Brain Injury, Multiple Sclerosis, Batten's Disease

Interview of a patient treated in Beijing Puhua International Hospital. The video is from the hospital's official youtube channel, so it may be biased

Elises International

Conditions Treated: No info available at their website

Advertisement video ofElises International

EmCell

Conditions Treated:ALS, Alzheimer's,Anemia, Cancer, Eye Diseases, Diabetes, Liver Diseases, Multiple Sclerosis Parkinson, and other

Location:Ukraine

EmCell Advertisement

Global Stem Cells

Conditions Treated:Type 2 Diabetes, Hepatitis C, Osteoarthritis, joint pain, hair regrowth, cosmetic anti-aging, ulcerative colitis, heart disease

Location:Bangkok Thailand

MD Stem Cells

New Zealand Stem Cell Clinic

Stem Cell Institute

Video of a patient treated in theStem Cell Institute. The video is taken from the clinic's official youtube channell,so it may be biased.

Okyanos Heart Institute

Conditions Treated:Cardiac conditions

Okyanos Promotinal Video

Stemedix, Inc

Conditions Treated:Multiple sclerosis, COPD, ALS, Alzheimers Disease, Parkinsons, Diabetes, Rheumatoid Arthritis and other

Location:Florida, United States

StemGenex

Conditions Treated: Multiple sclerosis, Alzheimer, Parkinson, Diabetes, Rheumatoid Arthritis and other

Location:San Diego, California.

Stem Cells Thailand

Conditions Treated:Alzheimer, Autism, Diabetes, Erectile Dysfunction, Face lift, Multiple Sclerosis, Arthritis and other

Regennex

Conditions Treated: Regennex mainly offers treatments for bone and cartilage regeneration in all major joints like knee, ankle, hip, back, shoulder etc

Dr. Centeno, founder of the clinic, talking about Regenexx

More here:
Stem Cell Clinics List | Stem Cells Freak

In a new study, researchers have uncovered a molecular explanation for the stress-relieving effects of such practices.

Study leader Ivana Buric, of the Centre for Psychology at Coventry University in the United Kingdom, and colleagues found that mind-body interventions (MBIs) "reverse" changes in DNA that cause stress.

For their study, the researchers looked at whether MBIs influence gene expression, the process by which genes create proteins and other molecules that affect cellular function.

From their analysis, the researchers found that people who practice MBIs experience reduced production of a molecule called nuclear factor kappa B (NF-kB), which is known to regulate gene expression.

The researchers explain that stressful events trigger activity in the sympathetic nervous system (SNS), which is responsible for the "fight-or-flight" response.

This SNS activity leads to the production of NF-kB, which produces molecules called cytokines that promote cellular inflammation. If this molecular reaction is persistent, it can lead to serious physical and mental health problems, such as depression and cancer.

The study suggests that MBIs, however, lower the production of NF-kB and cytokines. This not only helps to alleviate stress, but it also helps to stave off the associated health conditions.

"Millions of people around the world already enjoy the health benefits of mind-body interventions like yoga or meditation, but what they perhaps don't realize is that these benefits begin at a molecular level and can change the way our genetic code goes about its business," says Buric.

"These activities are leaving what we call a molecular signature in our cells, which reverses the effect that stress or anxiety would have on the body by changing how our genes are expressed. Put simply, MBIs cause the brain to steer our DNA processes along a path which improves our well-being."

The team says that future studies should explore how the molecular effects of MBIs on stress compare with other interventions, such as exercise and diet.

"But this is an important foundation to build on to help future researchers explore the benefits of increasingly popular mind-body activities," Buric concludes.

Separately, a new study has found that the treatment can be more harmful than helpful if cardiac stem cells are involved.

Researchers found that using patients' own cardiac stem cells to repair damaged heart tissue may not only be ineffective, but that the stem cells may also develop inflammatory properties that cause further heart damage.

Study leader Prof Jonathan Leor, of the Sackler Faculty of Medicine and Sheba Medical Center at Tel Aviv University in Israel, and colleagues recently reported their findings in the journal Circulation.

Prof Leor and colleagues came to their findings by isolating stem cells derived from the cardiac tissue of mice that had left ventricular dysfunction caused by a heart attack.

The team then injected the stem cells back into the hearts of the mice and assessed how they affected heart remodelling and function, compared with a saline solution.

Instead of repairing the rodents' damaged heart tissue, the researchers found that the transplanted stem cells developed inflammatory properties, which may increase heart damage."We found that, contrary to popular belief, tissue stem cells derived from sick hearts do not contribute to heart healing after injury," explained Prof Leor.

"Furthermore, we found that these cells are affected by the inflammatory environment and develop inflammatory properties. The affected stem cells may even exacerbate damage to the already diseased heart muscle."

An increasing number of end-stage heart failure patients are turning to stem cell therapy as a "last resort," but the researchers believe that the treatment should be approached with caution.

"Our findings suggest that stem cells, like any drug, can have adverse effects. We concluded that stem cells used in cardiac therapy should be drawn from healthy donors or be better genetically engineered for the patient."

Go here to read the rest:
'Yoga, meditation counters gene expression changes that cause stress' - Daily Times

Photo Credit: Nati Shohat / Flash 90

Patients with severe and end-stage heart failure have few treatment options available to them apart from transplants and miraculous stem cell therapy. But a new Tel Aviv University study has found that stem cell therapy may in fact harm patients with heart disease.

The research, led by Prof. Jonathan Leor of TAUs Sackler Faculty of Medicine and Sheba Medical Center and conducted by TAUs Dr. Nili Naftali-Shani, explores the current practice of using cells from the host patient to repair tissue and contends that this can prove deleterious or toxic for patients. The study was recently published in the journal Circulation.

We found that, contrary to popular belief, tissue stem cells derived from sick hearts do not contribute to heart healing after injury, said Prof. Leor. Furthermore, we found that these cells are affected by the inflammatory environment and develop inflammatory properties. The affected stem cells may even exacerbate damage to the already diseased heart muscle.

Tissue or adult stem cells blank cells that can act as a repair kit for the body by replacing damaged tissue encourage the regeneration of blood vessel cells and new heart muscle tissue. Faced with a worse survival rate than many cancers, a number of patients with heart failure have turned to stem cell therapy as a last resort.

But our findings suggest that stem cells, like any drug, can have adverse effects, said Prof. Leor. We concluded that stem cells used in cardiac therapy should be drawn from healthy donors or be better genetically engineered for the patient.

Hope for improved cardiac stem cell therapy

In addition, the researchers also discovered the molecular pathway involved in the negative interaction between stem cells and the immune system as they isolated stem cells in mouse models of heart disease. After exploring the molecular pathway in mice, the researchers focused on cardiac stem cells in patients with heart disease.

The results could help improve the use of autologous stem cells those drawn from the patients themselves in cardiac therapy, Prof. Leor said.

We showed that the deletion of the gene responsible for this pathway can restore the original therapeutic function of the cells, said Prof. Leor. Our findings determine the potential negative effects of inflammation on stem cell function as theyre currently used. The use of autologous stem cells from patients with heart disease should be modified. Only stem cells from healthy donors or genetically engineered cells should be used in treating cardiac conditions.

The researchers are currently testing a gene editing technique (CRISPER) to inhibit the gene responsible for the negative inflammatory properties of the cardiac stem cells of heart disease patients. We hope our engineered stem cells will be resistant to the negative effects of the immune system, said Prof. Leor.

Meanwhile, for those unable to profit from stem cell therapy, researchers at Ben Gurion University of the Negev (BGU) have developed a revolutionary new drug that may reverse the damage and repair the diseased heart.

The newly developed drug is a polymer which reduces the inflammation in cardiovascular tissue and stops plaque build-up in arteries. Then it goes one step further and removes existing plaque in the heart, leaving healthy tissue behind.

Professor Ayelet David, a researcher at BGU revealed the drug might also help people suffering from diabetes, hypertension and other conditions associated with old age.

See the original post:
Israeli Scientists: Stem Cell Therapy Not Good for All Heart Patients - The Jewish Press - JewishPress.com

A new study at Tel Aviv University shows that stem cell therapy, one of the few treatments available to patients with severe and end-stage heart failure, can actually harm them unless it is done differently.

We concluded that stem cells used in cardiac therapy should be drawn from healthy donors or be better genetically engineered for the patient, said lead researcher Jonathan Leor of the universitys Sackler Faculty of Medicine and Sheba Medical Center.

Doctors use tissue or adult stem cells to replace damaged tissue, which encourages regeneration of blood vessel cells and new heart muscle tissue. But cardiac stem cells from a diseased heart can lead to a toxic interaction via a molecular pathway between the heart and the immune system, the study found.

We found that, contrary to popular belief, tissue stem cells derived from sick hearts do not contribute to heart healing after injury, Leor said. Furthermore, we found that these cells are affected by the inflammatory environment and develop inflammatory properties. The affected stem cells may even exacerbate damage to the already diseased heart muscle.

The findings could suggest a way to make stem cell therapy safer for heart disease patients. The treatment is often a last resort, apart from getting a transplant.

Researchers discovered a molecular pathway involved in the toxic interaction while studying stem cells in mice with heart disease. By deleting the gene that makes the pathway, the cells ability to regenerate healthy tissue can be restored, they found.

The researchers are now testing a gene editing technique to delete the problem gene.

We hope our engineered stem cells will be resistant to the negative effects of the immune system, Leor said.

The study was conducted by TAUs Dr. Nili Naftali-Shani and published in the journal Circulation.

Read the original:
Study says some stem cells dangerous for heart patients | The Times ... - The Times of Israel

Each year, more than 700,000 people suffer myocardial infarction, aka a heart attack. Thanks to medical advances, there are myriad ways for a doctor to get the blood properly pumping and save a persons life. A cardiologist might give a patient medication to clear or loosen blockages. Or a doctor might insert a catheter to remove the clot, or place stents in the artery so it stays open.

These interventions have vastly improved survival rates, but they dont heal the damage caused by a cardiac event. The heart is really just one big muscle, and trauma to any muscle does some damage, which becomes scar tissue. Scar tissue on the heart means it functions far less optimally, which eventually leads to heart failure.

Short of a transplant, there isnt a long-term option to fix a damaged ticker. But a team of researchers say theyve come up with a high-tech solution that could revolutionize cardiology. Using 3-D printing technology, Brenda Ogle, an associate professor of biomedical engineering at the University of Minnesota-Twin Cities, has created a patch a doctor could apply to mend a patients broken heart.

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A false-color scanning electron micrograph (SEM) of a blood clot protruding from an arterial entrance in a heart chamber. This type of clot, known as coronary thrombosis, is the usual cause of myocardial infarction (heart attack). P. Motta/G. Macchiarelli/Sapienza University/Science Photo Libary/Getty

The concept is to imprint proteins that are native to the body, says Ogle. Weve used stem cellderived cardiac musclecardiac myocytesand actually mixed those with other cell types needed for blood vessels. This, she says, prevents what would otherwise happen naturally: The formation of a different type cells known as fibroblasts, which secrete scar tissue.

Ogle and her team of 3-D printing experts, clinical cardiologists and stem cell engineers have successfully tried the patch on mice. First, the team induced cardiac arrest in the rodents. When they then placed the cell patch on a mouse, researchers saw a significant increase in the functional capacity of the organ after just four weeks. We generated the continuous electric signal across the patch, and we can pace it: We can increase the frequency of beating up to three hertz, which is similar to a mouse heart, says Ogle who, this past January, published the findings of their experiment in Circulation Research, a journal from the American Heart Association.

The results of the experiment were so inspiring that in June 2016 the National Institutes of Health awarded her team a grant of more than $3 million, so they can now give pigs heart attacks and fix them with the patch. However, it will take some time to see their innovation in surgical departments, since using biological products such as cells requires a long regulatory process and, of course, quality assurance.

The replacement of muscle has been the holy grail for some time, says Ogle. Now we finally have the ability to take stem cells out of the body and develop the protocols to do that.

Read the original here:
How 3D Printing Can Help Mend a Broken Heart - Newsweek

June 15, 2017

Patients with severe and end-stage heart failure have few treatment options available to them apart from transplants and "miraculous" stem cell therapy. But a new Tel Aviv University study finds that stem cell therapy may, in fact, harm heart disease patients.

The research, led by Prof. Jonathan Leor of TAU's Sackler Faculty of Medicine and Sheba Medical Center and conducted by TAU's Dr. Nili Naftali-Shani, explores the current practice of using cells from the host patient to repair tissueand contends that this can prove deleterious or toxic for patients. The study was recently published in the journal Circulation.

"We found that, contrary to popular belief, tissue stem cells derived from sick hearts do not contribute to heart healing after injury," said Prof. Leor. "Furthermore, we found that these cells are affected by the inflammatory environment and develop inflammatory properties. The affected stem cells may even exacerbate damage to the already diseased heart muscle."

Tissue or adult stem cells"blank" cells that can act as a repair kit for the body by replacing damaged tissueencourage the regeneration of blood vessel cells and new heart muscle tissue. Faced with a worse survival rate than many cancers, many heart failure patients have turned to stem cell therapy as a last resort.

"But our findings suggest that stem cells, like any drug, can have adverse effects," said Prof. Leor. "We concluded that stem cells used in cardiac therapy should be drawn from healthy donors or be better genetically engineered for the patient."

Hope for improved cardiac stem cell therapy

In addition, the researchers also discovered the molecular pathway involved in the negative interaction between stem cells and the immune system as they isolated stem cells in mouse models of heart disease. After exploring the molecular pathway in mice, the researchers focused on cardiac stem cells in patients with heart disease.

The results could help improve the use of autologous stem cellsthose drawn from the patients themselvesin cardiac therapy, Prof. Leor said.

"We showed that the deletion of the gene responsible for this pathway can restore the original therapeutic function of the cells," said Prof. Leor. "Our findings determine the potential negative effects of inflammation on stem cell function as they're currently used. The use of autologous stem cells from patients with heart disease should be modified. Only stem cells from healthy donors or genetically engineered cells should be used in treating cardiac conditions."

The researchers are currently testing a gene editing technique (CRISPER) to inhibit the gene responsible for the negative inflammatory properties of the cardiac stem cells of heart disease patients. "We hope our engineered stem cells will be resistant to the negative effects of the immune system," said Prof. Leor.

Explore further: Adult stem cell types' heart repair potential probed

More information: Nili Naftali-Shani et al, Left Ventricular Dysfunction Switches Mesenchymal Stromal Cells Toward an Inflammatory Phenotype and Impairs Their Reparative Properties Via Toll-Like Receptor-4Clinical Perspective, Circulation (2017). DOI: 10.1161/CIRCULATIONAHA.116.023527

Journal reference: Circulation

Provided by: Tel Aviv University

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(HealthDay)A new method for delivering stem cells to damaged heart muscle has shown early promise in treating severe heart failure, researchers report online July 27 in Stem Cells Translational Medicine.

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Excerpt from:
Cardiac stem cells from heart disease patients may be harmful - Medical Xpress

Russias Progress 67 (67P) cargo craft is orbiting Earth and on its way to the International Space Station Friday morning carrying over three tons of food, fuel and supplies. Meanwhile, the three member Expedition 52 crew researched a variety of space science on Thursday while preparing for the arrival of the 67P.

Commander Fyodor Yurchikhin and Flight Engineer Jack Fischer will monitor the automated docking of the 67P to the Zvezda service module Friday at 7:42 a.m. EDT. NASA TV will broadcast live the resupply ships approach and rendezvous beginning at 7 a.m. The 67Ps docking will mark four spaceships attached to the space station.

Fischer spent the morning photographing mold and bacteria samples on petri dishes as part of six student-led biology experiments that are taking place inside a NanoRacks module. In the afternoon, he removed protein crystal samples from a science freezer, let them thaw and observed the samples using a specialized microscope.

Flight Engineer Peggy Whitson tended to rodents Thursday morning cleaning their habitat facilities and restocking their food. In the afternoon, she moved to human research swapping out samples for the Cardiac Stem Cells study that is exploring why living in space may accelerate the aging process.

Continue reading here:
Station Crew Researches Mold, Rodents and Stem Cells as Cargo Ship Chases Station - Space Fellowship

If youre having a heart attack, your life might someday be saved by pond scum.

Thats because these lowly bacteria are capable of producing something a stricken heart desperately needs: oxygen.

In fact, when Stanford scientists injected massive doses of cyanobacteria into the hearts of rats who suffered the equivalent of a widow-maker heart attack, oxygen levels ballooned by a factor of 25.

The results, published Wednesday in the journal Science Advances, suggest a truly original approach to reducing the damage done to heart muscle when it is suddenly deprived of oxygen.

When blood flow to the heart is interrupted by a clot or the narrowing of vessels, the effect can be deadly, either now or later. Its not uncommon for a heart attack victim to survive his or her immediate ordeal, only to succumb to heart failure the effects of heart muscle weakened by its brush with oxygen deprivation months or years after the event.

Physicians have long sought to avert that lingering damage by restoring the flow of oxygenated blood to the heart muscle as quickly as possible. Wielding an arsenal of drugs, stents, grasping devices, saws, scalpels and long, threaded catheters, cardiac surgeons try to isolate, remove or dissolve clots in the arteries feeding the heart before cells start to die off and lasting damage is done. More recently, stem cells have shown great promise in restoring damaged heart muscle.

But this new approach to rescuing living tissue from so-called ischemic damage proceeds from the observation that oxygen abounds in our atmosphere as a result of photosynthesis the fuel-making industry of green plants all around us.

If a lack of oxygen is the problem when living tissue is deprived of blood flow, perhaps we should invite into our bodies the forests genius for manufacturing the gas our cells depend on to survive.

Every day we walk around and see trees, said Dr. Joseph Woo, chair of Stanford School of Medicines department of cardiothoracic surgery and the papers senior author. We wondered, would there be any possibility of taking plants and putting them next to the heart and getting them to work together?

Several years ago, researchers in Woos Stanford lab started by grinding spinach, and then kale, with mortar and pestle. When they introduced the green slurry to living tissue in Petri dishes and set them in the sun, nothing happened.

But when they tried a more primitive practitioner of photosynthesis pond scum the oxygenation effect was clear to see.

The scientists used cyanobacteria, the blue-green algae that often blooms on the surface of still waters, to supply life-giving oxygen to the stricken hearts of rats. After clamping off the largest of three arteries feeding blood to the heart the left anterior descending coronary artery the researchers injected those hearts with tens of millions of the single-celled organisms.

For two full hours one hour while the clamp remained in place and a second hour after it was removed the animals incisions remained open. During that time, the hearts of the treated rats were exposed to strong light, which jump-started the photosynthetic process.

Just as they would on the surface of a pond, the cyanobacteria used the pigment chlorophyll to combine water, carbon dioxide and light to produce glucose. The incidental byproduct of that process oxygen kept cells deprived of oxygenated blood from dying off in droves.

A day later, the damage to the hearts of treated rats was less than half as severe as that seen in rats that got an inactive treatment, according to the study.

And four weeks after the ischemic crisis, the hearts of rats that got the photosynthesis treatment performed dramatically better than the hearts of rats that did not.

In humans, an improvement in heart function of the magnitude shown in treated rats would have profound clinical implications, the Stanford team wrote. If humans were to reap benefits as great as those seen in the lab rats, they added, such a treatment probably would spell the difference between a healthy patient and one suffering from heart failure.

Woo sees the new research as a proof of principle that photosynthesis, in some form, might someday be used as a bridge treatment for patients who have had blood flow cut off to any organ. It might be useful in sustaining organs harvested for transplant during their long journey to a new owner, Woo said, and in preventing the death of brain cells during a stroke. It may even one day improve the treatment of malignant tumors that thrive in oxygen-deprived environments, he added.

But in its current form, a photosynthetic bridge treatment is far from ready for use in clinical settings.

It would be very suboptimal to have to crack someones chest open and shine the light on them to begin the oxygenation process, Woo said. To work around that impracticality, a team at Stanford is already working on supercharged versions of the cyanobacteria that rescued rats hearts in his teams new paper.

Researchers may have to engineer ways other than direct exposure to visible light to jump-start the photosynthesis process, he said. Plants or cyanobacteria may be amenable to genetic engineering that would allow them to produce oxygen more copiously, or to initiate photosynthesis in response to energy at wavelengths that can penetrate skin and other tissue.

Remarkably, the direct injection into the heart of millions of cyanobacteria did not cause any infection. Nor did it prompt the rats immune systems to mount a defensive response a reaction that can be just as deadly as infection.

Virtually all of the millions of single-celled organisms injected into the rats hearts were gone 24 hours after the experiment. And in a more thorough search four weeks later, the researchers could find no sign of infection or of lingering bacterial cells anywhere near the hearts of rats who got the treatment.

If cyanobacteria were someday to play a key role in the treatment of human disease, it would be a nice footnote to an already striking record of accomplishment. Thats because cyanobacteria one of the largest, oldest and most important groups of bacteria on Earth are already pretty much responsible for life as we know it.

In the Archaean and Proterozoic eons 2.5 billion years ago, cyanobacteria flourished by using light and carbon dioxide for nourishment. The oxygen given off by this photosynthesis created Earths oxygen-rich atmosphere, making the evolution of ever more complex life forms possible.

Read the original post:
How oxygen-producing pond scum could save your life after a heart attack - Los Angeles Times

Domainex will expand its two-year-old collaboration with Imperial College London to discover new therapies that reduce heart muscle damage during heart attacks, the partners said today.

Domainex and Imperial aim to discover a treatment that inhibits the enzyme MAP4K4, which is linked to cell death following heart attacks. Since the collaboration was launched in 2015, the partners said, they have discovered novel, potent, and selective MAP4K4 inhibitors using human cardiac muscle grown from human induced pluripotent stem cells (iPSCs).

The inhibitors have shown promise in protecting these cells against oxidative stress, a trigger for cell death during heart attacks, Domainex and Imperial said.

As a result of the progress, Imperial College London said, its Professor Michael Schneider, Ph.D., has secured a follow-on award of 4.5 million (nearly $5.8 million) from the Wellcome Trusts Seeding Drug Discovery initiative to continue the research.

From its Medicines Research Centre near Cambridge, U.K., Domainex said, its researchers will continue to provide integrated drug discovery servicesincluding further biochemical, cellular and biophysical assay screening, and structure-guided medicinal chemistry coupled with drug metabolism, safety, and pharmacokinetic assessment of promising candidates.

Domainex and Imperial said they aim to advance potential treatments into preclinical development and ultimately to clinical evaluation.

"We have already identified a number of very exciting, novel inhibitors through structure-based drug design," Domainex CSO Trevor Perrior said in a statement. The innovative cardiac muscle assay developed by the team here at Domainex working in partnership with Imperial College London, is enabling early testing on human cardiac muscle cells, which will make cardiac drug discovery more efficient and effective in identifying efficacious candidate drugs.

View post:
Domainex, Imperial College London Extend Cardiac Therapy Collaboration - Genetic Engineering & Biotechnology News

Drug discovery sleuths at Domainex in Cambridge have expanded a partnership with Imperial College London to find novel therapies that reduce heart muscle damage during heart attacks.

The aim is to discover a drug that inhibits the enzyme MAP4K4, which plays a key role in triggering cell death following cardiac arrest.

Significant progress made in the first two years of the collaboration has enabled Imperials Professor Michael Schneider to secure a follow-on award of 4.5 million from Wellcomes Seeding Drug Discovery scheme, to continue the pioneering research.

Since initiating the project in 2015, Domainex and Imperial College London have worked closely together to advance promising therapeutic candidates. Novel, potent, and selective MAP4K4 inhibitors have already been discovered. Using human cardiac muscle grown from human induced pluripotent stem cells, these inhibitors have shown efficacy in protecting these cells against oxidative stress, a known trigger for cell death during heart attacks.

Trevor Perrior (pictured), chief scientific officer at Domainex, said: We have already identified a number of very exciting, novel inhibitors through structure-based drug design.

We look forward to continuing our strong partnership with Professor Schneider and his team and to building on the excellent progress made to date. The innovative cardiac muscle assay developed by the team here at Domainex working in partnership with Imperial College London is enabling early testing on human cardiac muscle cells, which will make cardiac drug discovery more efficient and effective in identifying efficacious candidate drugs.

The Domainex team will continue to provide integrated drug discovery services from its Medicines Research Centre at Chesterford Research Park near Cambridge UK including further biochemical, cellular and biophysical assay screening, structure-guided medicinal chemistry, coupled with drug metabolism, safety and pharmacokinetic assessment of promising candidates. The goal is to advance the project efficiently into pre-clinical development and ultimately to clinical evaluation.

Go here to read the rest:
Domainex and Imperial step up cardiac research - Business Weekly

Researchers at the Institute of Bioengineering and Nanotechnology (IBN) of A*STAR have engineered a three-dimensional heart tissue from human stem cells to test the safety and efficacy of new drugs on the heart.

Cardiotoxicity, which can lead to heart failure and even death, is a major cause of drug withdrawal from the market. Antibiotics, anticancer and antidiabetic medications can have unanticipated side effects for the heart. So it is important to test as early as possible whether a newly developed drug is safe for human use. However, cardiotoxicity is difficult to predict in the early stages of drug development, said Professor Jackie Y. Ying, Executive Director at IBN.

A big part of the problem is the use of animals or animal-derived cells in preclinical cardiotoxicity studies due to the limited availability of human heart muscle cells. Substantial genetic and cardiac differences exist between animals and humans. There have been a large number of cases whereby the tests failed to detect cardiovascular toxicity when moving from animal studies to human clinical trials*.

Existing screening methods based on 2D cardiac structure cannot accurately predict drug toxicity, while the currently available 3D structures for screening are difficult to fabricate in the quantities needed for commercial application.

To solve this problem, the IBN research team fabricated their 3D heart tissue from cellular self-assembly of heart muscle cells grown from human induced pluripotent stem cells. They also developed a fluorescence labelling technology to monitor changes in beating rate using a real-time video recording system. The new heart tissue exhibited more cardiac-specific genes, stronger contraction and higher beating rate compared to cells in a 2D structure.

Using the 3D heart tissue, we were able to correctly predict cardiotoxic effects based on changes in the beating rate, even when these were not detected by conventional tests. The method is simple and suitable for large-scale assessment of drug side effects. It could also be used to design personalized therapy using a patients own cells, said lead researcher Dr Andrew Wan, who is Team Leader and Principal Research Scientist at IBN.

The researchers have filed a patent on their human heart tissue model, and hope to work with clinicians and pharmaceutical companies to bring this technology to market.

This article has been republished frommaterialsprovided by A*STAR. Note: material may have been edited for length and content. For further information, please contact the cited source.

Reference:

Lu, H. F., Leong, M. F., Lim, T. C., Chua, Y. P., Lim, J. K., Du, C., & Wan, A. C. (2017). Engineering a functional three-dimensional human cardiac tissue model for drug toxicity screening. Biofabrication, 9(2), 025011. doi:10.1088/1758-5090/aa6c3a

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Human Heart Tissue Grown from Stem Cells Improves Drug Testing ... - Technology Networks

Cardiovascular disease is the number one cause of death worldwide in men, women and children, claiming more than 17 million lives each year. The effects of congestive heart failure and acute myocardial infarction (heart attack) present great challenges for doctors and researchers alike.

In this section:

Heart attacks cause damage to the heart muscle, making it less efficient at pumping blood throughout the circulatory system.

Your heart is constructed of several types of cells. For mending damaged heart tissue, researchers generally focus on three specific heart cell types:

Gladstone Institutes. Close up of a mouse heart stained to reveal the important structural protein that helps heart muscle cells to contract (red). The cell nuclei are labeled in magenta.

Despite major advances in how heart disease is managed, heart disease is progressive. Once heart cells are damaged, they cannot be replaced efficiently, at least not as we understand the heart today.

There is evidence that the heart has some repair capability, but that ability is limited and not yet well understood.

Heart failure is a general term to describe a condition in which the hearts blood-pumping action is weaker than normal. How much weaker varies widely from person to person, but the weakness typically gets worse over time. Blood circulates more slowly, pressure in the heart increases, and the heart is unable to pump enough oxygen and other nutrients to the rest of the body. To compensate, the chambers of the heart may stretch to hold more blood, or the walls of the chambers may thicken and become stiff. Eventually, the kidneys respond to the weaker blood-pumping action by retaining more water and salt, and fluid can build up in the arms, legs, ankles, feet, and even around the lungs. This general clinical picture is called congestive heart failure.

Many conditions can lead to congestive heart failure. Among the most common are:

The American Heart Association defines normal blood pressure for an adult as 120/80 or lower. What do those numbers mean? The top number is the systolic pressure that is, the pressure in your arteries when your heart beats, or contracts. The bottom number measures diastolic pressure, or the pressure in your arteries between beats, when the heart refills with blood.

In the early stages of congestive heart failure, treatment focuses on lifestyle changes (healthy diet, regular exercise, quitting smoking, etc.) and specific medications; the goals are to slow down any progression of the disease, lessen symptoms and improve quality of life.

Medications called beta blockers are often prescribed after a heart attack or to treat high blood pressure. Other medications called ACE inhibitors prevent heart failure from progressing.

For moderate to severe congestive heart failure, surgery may be necessary to repair or replace heart valves or to bypass coronary arteries with grafts. In severe cases, patients may be put on fluid and salt restriction and/or have pacemakers or defibrillators implanted to control heart rhythms.

Acute myocardial infarction, or a heart attack, occurs when the blood vessels that feed the heart are blocked, often by a blood clot that forms on top of the blockage. The blockage is a build-up of plaque that is composed of fat, cholesterol, calcium and other elements found in the blood. Without oxygen and other nutrients from the blood, heart cells die, and large swaths of heart tissue are damaged.

After a heart attack, scar tissue often forms over the damaged part of the heart muscle, and this scar tissue impairs the hearts ability to keep beating normally and pumping blood efficiently. The heart ends up working harder, which weakens the remaining healthy sections of the heart; over time, the patient experiences more heart-related health issues.

Doctors often use a procedure called angioplasty to disrupt the blood clot and widen clogged arteries. Angioplasty involves inserting and inflating a tiny balloon into the affected artery. Sometimes this temporary measure is enough to restore blood flow. However, angioplasty is often combined with the insertion of a small wire mesh tube called a stent, which helps keep the artery open and reduces the chances that it will get blocked again.

Other post-heart attack treatments include the regular use of blood thinners (for example, low-dose aspirin) to prevent new clots from forming and other medications to help control blood pressure and blood cholesterol levels. Lifestyle changes, such as lowering salt and fat intake, exercising regularly, reducing alcohol consumption and quitting smoking are also recommended to reduce the chances of a subsequent heart attack.

Scientists and clinicians have long suspected and recently confirmed that a persons genetic makeup contributes to the likelihood of their having a heart attack. Learn more here

The goals of heart disease research are to understand in greater detail what happens in heart disease and why, and to find ways to prevent damage or to repair or replace damaged heart tissue. Scientists have learned much about how the heart works and the roles different cells play in both normal function and in disease, and they are learning more about how cardiomyocytes and cardiac pacemaker cells operate, including how they communicate with each other and how they behave when damage occurs.

Researchers grow cardiomyocytes in the lab from the following sources:

These cells will beat in unison in a culture dish, the same way they do in a living heart muscle. This is exciting to consider, as researchers explore whether they might someday grow replacement tissue for transplantation into patients. However, it is not yet known whether lab-grown cardiomyocytes will integrate or beat in unison with surrounding cells if they are transplanted into the human body.

Gordon Keller Lab. Heart cells beating in a culture dish.

Scientists also use various types of stem cells to study the hearts natural repair mechanisms and test ways to enhance those repair functions. The evidence we have so far suggest thats the heart may have a limited number of cardiac stem cells that may conduct some repair and replacement functions throughout an individuals life, but we dont know where they live in the heart or how they become activated.

Human cells made from iPS cells are also incredibly useful for creating human models of heart disease to get a better understanding of exactly what goes wrong and for testing different drugs or other treatments. They can also be used to help predict which patients might have toxic cardiac side effects from drugs for other diseases such as cancer.

The key to treating heart disease is finding a way to undo the damage to the heart. Researchers are trying several tactics with stem cells to repair or replace the damaged heart tissue caused by congestive heart failure and heart attacks.

Areas under investigation include:

The Europe-wide BAMI clinical trial (the effect of intracoronary reinfusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction) that began in 2014, is testing the infusion of cells from the participants bone marrow into one of the coronary arteries (one of two major arteries that supply the heart) to spark repair activity. However, it is not yet clear whether these cells will support heart repair function or in what way.

Researchers are also exploring transplantation of cardiomyocytes generated from both iPS cells and cardiac progenitor cells. They need to determine whether these transplanted cells survive and function in the body and whether they help speed up the hearts innate repair mechanisms.

Some of these approaches are still being evaluated in the lab while others are already being tested in clinical trials around the world. However, these trials are in their early stages and the results will not be clear for many years. Indeed, some published data conflict in critical ways, so carefully designed and well-monitored trials are key to working out what is safe and effective.

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Heart Disease - Closer Look at Stem Cells

Activating stem cells Wnt signaling pathways can drive cardiac progenitor cells to become epicardium instead of myocardium cells.

A process using human stem cells can generate epicardium cells that cover the external surface of a human heart, according to a multidisciplinary team of researchers.

In 2012, we discovered that if we treated human stem cells with chemicals that sequentially activate and inhibit the Wnt signaling pathway, they become myocardium muscle cells, says Xiaojun Lance Lian, assistant professor of biomedical engineering and biology, who is leading the study at Pennsylvania State University (Penn State). Myocardium, the middle of the hearts three layers, is the thick, muscular part that contracts to drive blood through the body. The Wnt signaling pathway is a group of signal transduction pathways made of proteins that pass signals into a cell using cell-surface receptors.

We needed to provide the cardiac progenitor cells with additional information in order for them to generate into epicardium cells, but prior to this study, we didnt know what that information was, Lian says. Now, we know that if we activate the cells Wnt signaling pathway again, we can re-drive these cardiac progenitor cells to become epicardium cells, instead of myocardium cells.

Lance Lian/Penn State

The groups results bring researchers one step closer to regenerating an entire heart wall. Through morphological assessment and functional assay, the researchers found that the generated epicardium cells were similar to epicardium cells in living humans and those grown in the laboratory.

The last piece is turning cardiac progenitor cells to endocardium cells (the hearts inner layer), and we are making progress on that, Lian says.

The groups method of generating epicardium cells could be useful in clinical applications, for patients who suffer a heart attack.

Heart attacks occur due to blockage of blood vessels, Lian says. This blockage stops nutrients and oxygen from reaching the heart muscle, and muscle cells die. These muscle cells cannot regenerate themselves, so there is permanent damage, which can cause additional problems. These epicardium cells could be transplanted to the patient and potentially repair the damaged region.

In addition to generating the epicardium cells, researchers can keep them proliferating in the lab after treating them with a cell-signaling pathway Transforming Growth Factor Beta (TGF) inhibitor.

After 50 days, our cells did not show any signs of decreased proliferation. However, the proliferation of the control cells without the TGF Beta inhibitor started to plateau after the tenth day, Lian says.

Pennsylvania State University http://www.psu.edu

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Stem cells regenerate external layer of a human heart - Today's Medical Developments

June 8, 2017 This image shows human heart muscle cells growing in the 3D tissue structure. The cells have been stained with fluorescent molecules to identify the nuclei in blue, and cardiac-specific protein, in green. Credit: Agency for Science, Technology and Research (A*STAR), Singapore

Researchers at the Institute of Bioengineering and Nanotechnology (IBN) of A*STAR have engineered a three-dimensional heart tissue from human stem cells to test the safety and efficacy of new drugs on the heart.

"Cardiotoxicity, which can lead to heart failure and even death, is a major cause of drug withdrawal from the market. Antibiotics, anticancer and antidiabetic medications can have unanticipated side effects for the heart. So it is important to test as early as possible whether a newly developed drug is safe for human use. However, cardiotoxicity is difficult to predict in the early stages of drug development," said Professor Jackie Y. Ying, Executive Director at IBN.

A big part of the problem is the use of animals or animal-derived cells in preclinical cardiotoxicity studies due to the limited availability of human heart muscle cells. Substantial genetic and cardiac differences exist between animals and humans. There have been a large number of cases whereby the tests failed to detect cardiovascular toxicity when moving from animal studies to human clinical trials.

Existing screening methods based on 2-D cardiac structure cannot accurately predict drug toxicity, while the currently available 3-D structures for screening are difficult to fabricate in the quantities needed for commercial application.

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To solve this problem, the IBN research team fabricated their 3-D heart tissue from cellular self-assembly of heart muscle cells grown from human induced pluripotent stem cells. They also developed a fluorescence labelling technology to monitor changes in beating rate using a real-time video recording system. The new heart tissue exhibited more cardiac-specific genes, stronger contraction and higher beating rate compared to cells in a 2-D structure.

"Using the 3-D heart tissue, we were able to correctly predict cardiotoxic effects based on changes in the beating rate, even when these were not detected by conventional tests. The method is simple and suitable for large-scale assessment of drug side effects. It could also be used to design personalized therapy using a patient's own cells," said lead researcher Dr Andrew Wan, who is Team Leader and Principal Research Scientist at IBN.

The researchers have filed a patent on their human heart tissue model, and hope to work with clinicians and pharmaceutical companies to bring this technology to market.

This finding was reported recently in the Biofabrication journal.

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

More information: Hong Fang Lu et al. Engineering a functional three-dimensional human cardiac tissue model for drug toxicity screening, Biofabrication (2017). DOI: 10.1088/1758-5090/aa6c3a

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Human heart tissue grown from stem cells improves drug testing - Medical Xpress

Editors note: The SpaceX Falcon 9 rocket scheduled to launch today from Florida was delayed due to weather conditions. The launch occured on Saturday, June 3.

A SpaceX rocket wasslated to launch two University of Colorado Boulder-built payloads to the International Space Station (ISS) from Florida on Thursday, including oneto look at changes in cardiovascular stem cells in microgravity that may someday help combat heart disease on Earth.

The Dragon spacecraft

The second payload will be used for rodent studies testing a novel treatment for bone loss in space, which has been documented in both astronauts and mice. The two payloads were developed by BioServe Space Technologies, a research center within the Ann and H.J Smead Department of Aerospace Engineering,

We have a solid relationship with SpaceX and NASA that allows us to regularly fly our flight hardware to the International Space Station, said BioServe Director Louis Stodieck. The low gravity of space provides a unique environment for biomedical experiments that cannot be reproduced on Earth, and our faculty, staff and students are very experienced in designing and building custom payloads for our academic, commercial and government partners.

The experiments will be launched on a SpaceX Falcon 9 rocket from Cape Canaveral, Florida, and carried to the ISS on the companys Dragon spacecraft. The SpaceX-CRS-11 mission launching Thursday marks BioServes 55th mission to space.

The cardiovascular cell experiments, designed by Associate Professor Mary Kearns-Jonker of the Loma Linda University School of Medicine in Loma Linda, California, will investigate how low gravity affects stem cells, including physical and molecular changes. While spaceflight is known to affect cardiac cell structure and function, the biological basis for such impacts is not clearly understood, said BioServe Associate director Stefanie Countryman.

As part of the study, the researchers will be comparing changes in heart muscle stem cells in space with similar cells simultaneously cultured on Earth, said Countryman. Researchers are hopeful the findings could help lead to stem cell therapies to repair damaged cardiac tissue. The findings also could confirm suspicions by scientists that microgravity speeds up the aging process, Countryman said.

For the heart cell experiments, BioServe is providing high-tech, cell-culture hardware known as BioCells that will be loaded into shoebox-sized habitats on ISS. The experiments will be housed in BioServes Space Automated Bioproduct Lab (SABL), a newly updated smart incubator that will reduce the time astronauts spend manipulating the experiments.

The second experiment, created by Dr. Chia Soo of the UCLA School of Medicine, will test a new drug designed to not only block loss of bone but also to rebuild it.

The mice will ride in a NASA habitat designed for spaceflight to the ISS. Once on board, some mice will undergo injections with the new drug while others will be given a placebo. At the end of the experiments half of the mice will be returned to Earth in SpaceXs Dragon spacecraft and transported to UCLA for further study, said Stodieck, a scientific co-investigator on the experiment.

BioServes Space Automated Byproduct Lab

In addition to the two science experiments, BioServe is launching its third SABL unit to the ISS. Two SABL units are currently onboard ISS supporting multiple research experiments, including three previous stem cell experiments conducted by BioServe in collaboration with Stanford University, the Mayo Clinic and the University of Minnesota.

The addition of the third SABL unit will expand BioServes capabilities in an era of high-volume science on board the ISS, said Countryman.

BioServe researchers and students have flown hardware and experiments on missions aboard NASA space shuttles, the ISS and on Russian and Japanese government cargo rockets. BioServe previously has flown payloads on commercial cargo rockets developed by both SpaceX, headquartered in Hawthorne, California, and Orbital ATK, Inc. headquartered in Dulles, Virginia.

Since it was founded by NASA in 1987, BioServe has partnered with more than 100 companies and performed dozens of NASA-sponsored investigations. Itspartners include large and small pharmaceutical and biotechnology companies, universities and NASA-funded researchers, and investigations sponsored by the Center for the Advancement of Science in Space, which manages the ISS U.S. National Laboratory. CU-Boulder students are involved in all aspects of BioServe research efforts, said Stodieck.

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SpaceX launches CU-built heart, bone health experiments to space station - CU Boulder Today