Vistagen Therapeutics, Inc.

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"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. Our lead CNS product candidate, AV-101, is a new generation oral antidepressant drug candidate in Phase 2 development. AV-101's mechanism of action is fundamentally differentiated from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat major depressive disorder (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, and one of the world's foremost experts on the use of low dose IV ketamine and other NMDA receptor antagonists to treat MDD. VistaGen is also 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 antidepressant therapies. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the 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, Parkinson's disease and Huntington's disease, where modulation of the NMDAR, AMPA pathway and/or key active metabolites of AV-101 may achieve therapeutic benefit. In addition to our AV-101 programs, VistaStem, VistaGens wholly owned subsidiary, is applying our human pluripotent stem cell (hPSC) technology platform and CardioSafe 3D, our customized in-vitro human cardiac cell bioassay system, to predict potential heart toxicity of new chemical entities (NCEs) long before they are tested in preclinical animal studies and human clinical studies. Having successfully assessed AV-101 and numerous other drug candidates to establish the clinically predictive capabilities of CardioSafe 3D, we are now using CardioSafe 3D to expand our pipeline through cardiac liability-focused small molecule drug rescue, and to participate, together with a select group of companies, in the FDA's Comprehensive in-vitro Proarrhythmia Assay (CIPA) initiative designed to change the landscape of preclinical drug development by providing a more complete and accurate assessment of potential drug effects on cardiac risk. We are also focused on collaborating with others to advance development and commercialization of medicine and cell therapy applications of our stem cell technology across a range of cell types, including blood, bone, cartilage, heart and liver cells. In December 2016, we entered into an exclusive sublicense agreement with BlueRock Therapeutics L.P, a next generation regenerative medicine company established by Bayer AG and Versant Ventures, for our rights to proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease."

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Genetically and immune-mediated disease, Multiple Sclerosis symptoms and progression are unpredictable at the time of diagnosis.

Multiple Sclerosis is an inflammatory disease that affects the brain and spinal cord of an individual. It occurs due to the combination of genetic susceptibility and can also occur due to low vitamin levels, virus, and environmental factors. The Multiple Sclerosis Foundation estimates that more than 400,000 people in the United States and about 2.5 million people around the world have Multiple Sclerosis. No large epidemiological studies have been reported from India but calculations based on hospital data in the 1970s suggested an approximate prevalence rate of only 0.17 to 1.33 per 100,000 in different parts of India. Increased awareness and the rise in the number of neurologists and availability of MRI has led the current estimates to about 7 to 10 per 100,000. As there are many Indians who still do not have access to adequate medical facilities especially in the rural sector, there can be a rise in the figures mentioned too. As per hospital-based studies within India, an increase in the incidence of Multiple Sclerosis from 1.58% to 2.54% has been noted in the last decade.

This immune-mediated disease affects the protective covering (myelin sheath) around the nerves which result in neurological defects. With the help cellular therapy, utilising the various properties of stem cells, Multiple Sclerosis can be treated. In autologous cell-based therapy, stem cells from the patients own body are transplanted, which resets the immune system. A patient suffering from Multiple Sclerosis is often treated with immune-suppressive drugs and monoclonal antibodies. But, these agents are associated with side effects with long-term use and are not entirely effective in managing symptoms. Autologous stem cells are neuroprotective and also have other paracrine properties by which patients of Multiple Sclerosis can benefit. The immunomodulatory properties of the stem cells help reduce damage in the central nervous system of patients with Multiple Sclerosis. It also helps in regeneration of the injured nerves, said Dr Pradeep Mahajan, Regenerative Medicine researcher at StemRx Bioscience Solutions Pvt. Ltd.

The time taken to heal varies from patient to patient and can go from 2 months to 1 year. There are various ways to administer the stem cells back into the body, the route depending on the condition and requirement of the patient. In neurological conditions, the appropriate route of administration would be the one which facilitates cell delivery into the brain.

Published: May 30, 2017 4:09 pm | Updated:May 30, 2017 4:10 pm

Disclaimer: TheHealthSite.com does not guarantee any specific results as a result of the procedures mentioned here and the results may vary from person to person. The topics in these pages including text, graphics, videos and other material contained on this website are for informational purposes only and not to be substituted for professional medical advice.

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Indian researchers develop 3D bioprinted cartilage The Hindu The bioink has high concentration of bone-marrow derived cartilage stem cells, silk proteins and a few factors. The chemical composition of the bioink supports cell growth and long-term survival of the cells. The cartilage developed in the lab has ...

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26 May 2017

Could tyrosine kinase inhibitors, a standard tool of cancer treatment, help people with amyotrophic lateral sclerosis? Converging evidence suggests that this drug class may slow ALS progression, perhaps through multiple mechanisms. In the May 24 Science Translational Medicine, researchers led by Haruhisa Inoue at Kyoto University, Japan, report that numerous different inhibitors of the tyrosine kinases Src and c-Abl improve the survival of motor neurons from ALS patients. The compounds act by stimulating autophagy, which accelerates the removal of toxic proteins. One of the most potent inhibitors, bosutinib, boosted motor neuron survival by 50 percent and modestly lengthened the lives of ALS model mice, the authorsreport.

In related news, researchers recently reported positive findings from a Phase 3clinical trial of another tyrosine kinase inhibitor, masitinib, at the European Network for the Cure of ALS (ENCALS) annual meeting, held May 18 to 20 in Ljubljana, Slovenia. This inhibitor, which is approved to treat tumors in animals but not people, reportedly doused neuroinflammation in the spinal cord. Patients on the drug maintained motor abilities four months longer than did those on placebo, a statistically significant improvement. AB Science in Paris, the manufacturer, has applied to the European Medicines Agency for approval to use the drug in people, and is planning to start another Phase 3trial this year before applying for approval from the U.S. Food and DrugAdministration.

The data suggest that tyrosine kinase inhibitors might help in other neurodegenerative diseases such as Alzheimers and Parkinsons, which also accumulate toxic proteins and cause neuroinflammation, said Charbel Moussa at Georgetown University, Washington, D.C. He noted that many of these compounds are already FDA-approved for other conditions, and can be used at much lower doses for neurodegenerative disease than for cancer. These drugs represent a promising alternative to antibody and vaccination strategies, he told Alzforum. He was not involved in either of thesestudies.

ALS in a Dish. Stem cells derived from people with familial ALS differentiate into neurons in culture that express motor neuron markers HB9, ChAt, and SMI-32. Nuclei are stained blue. [Courtesy of Science TranslationalMedicine/AAAS.]

The need for new drugs for ALS is immense. In this devastating disease, spinal motor neurons wither, robbing people of motor control and killing them typically within three to five years. Approved treatments are limited to riluzoleand edaravone, which was just approved in the U.S. this month (see May 2017 news). Both modestly slow functional decline, though efficacy data for edavarone remains sparse. Researchers are still seeking betteroptions.

To cast a wider net, Inoue and colleagues screened 1,416 compounds that are either approved for human use or in clinical trials. First author Keiko Imamura generated induced pluripotent stem cells (iPSCs) from a single ALS patient who carried a SOD1 mutation. The authors differentiated these cells into spinal motor neurons and cultured them for seven days, added the compounds, and assessed survival one week later. In this screen, 27 compounds boosted survival more than three standard deviations above that of untreated cells. Half of these compounds targeted the Src/c-Abl signaling pathway. These cytosolic tyrosine kinases participate in numerous cellular processes and are implicated in cancer. To confirm these enzymes mediated the drug effect, the authors knocked down Src and c-Abl with short interfering RNAs, and again saw improved motor neuronsurvival.

Among the hits, the authors selected bosutinib for follow up. This drug is approved to treat chronic myelogenous leukemia, directly inhibits Src and c-Abl, and acts at lower doses than the other compounds in the screen. Bosutinib normalized autophagy in the diseased motor neurons. Compounds that blocked autophagy weakened the protective benefits of bosutinib, suggesting this was its mechanism of action. In keeping with this, other known autophagy boosters, such as rapamycin, also improved motor neuron survival. As might be expected, revving up autophagy cleaned up deposits of misfolded, toxic SOD1. The authors did not detail how inhibition of Src and c-Abl stimulated autophagy, but other work provides clues. Moussa and colleagues have reported that c-Abl inhibition activates the ubiquitin ligase parkin, which then interacts with autophagy proteins such as beclin-1 to stimulate degradation of proteins including A and -synuclein (see Lonskaya et al., 2013; Lonskaya et al., 2014; Wenqiang et al., 2014). A sister compound to bosutinib, nilotinib, is currently in Phase 2 trials for PDand ADthat Moussa and colleagues at Georgetown are running (see Nov 2015 conference news).

Only 2 percent of people with ALS carry SOD1 mutations. What about other forms of the disease? To expand their study, the authors generated motor neurons from three ALS patients with TDP-43 mutations, three with C9ORF72 expansions, and three with sporadic disease. Most people with ALS, regardless of their mutation status, accumulate misfolded TDP-43, and C9ORF72 is the most common familial mutation. In this study, bosutinib lowered levels of misfolded TDP-43 and poly dipeptide repeats formed from the C9ORF72 expansion; it also improved survival in all cell lines save for one from a sporadiccase.

Next, the authors tested bosutinib in the SOD1-G93A mouse model of ALS. These animals become paralyzed at four and die by six months of age. The authors injected a single dose, 5 mg/kg/day, intraperitoneally for six weeks beginning at two months of age. Src and c-Abl activity in the spinal cord was cut in half, indicating target engagement. Treated mice accumulated slightly less misfolded SOD1 and had about three times as many surviving motor neurons in their spinal cords as untreated ones. Nevertheless, treatment delayed disease onset by only 11 days and extended survival by just eightdays.

Why didnt the drug work better in mice, given the promising in vitro data? Nonneuronal cells such as astrocytes contribute to ALS pathology, but Inoues screen did not test for effects of bosutinib on these cells (e.g. Oct 2014 news; Nov 2014 news). In an email to Alzforum, Inoue also suggested that bosutinib could be optimized to better enter the brain and avoid potential off-target effects. Peter Davies at the Feinstein Institute for Medical Research in Manhasset, New York, pointed out that tyrosine kinase inhibitors such as bosutinib are typically not specific for c-Abl. I would like to see pharma make more specific compounds, because then we would learn if the key factor really is c-Abl, rather than another kinase, and there would be fewer off-target effects, Davies wrote to Alzforum. He acknowledged that making specific c-Abl inhibitors is a challenging task, and that companies have tried and abandoned some past efforts for lack ofsuccess.

The findings from bosutinib and nilotinib complement those for masitinib. This veterinary drug seems to act mostly on immune cells. Preclinical studies suggested masitinib inhibits the tyrosine kinases CSF-1R and C-kit in microglia, macrophages, and mast cells, circulating white blood cells that trigger allergic and inflammatory reactions. In animal models, masitinib prevents microgliosis and astrogliosis in the spinal cord, as well as the infiltration of mast cells and macrophages into neuromuscular junctions (see Trias et al., 2016). This provides a rational basis for the protective effects of masitinib in delaying neuromuscular junction denervation. However, more research is needed to understand the detailed mechanism of action of the drug, Luis Barbeito at the Pasteur Institute of Montevideo, Uruguay, wrote to Alzforum. Barbeito presented preclinical data on masitinib atENCALS.

In the Phase 3 trial, 394 patients from nine countries took either 4.5 mg/kg masitinib, 3 mg/kg, or placebo for nearly a year. By prespecified plan, the researchers stratified participants into fast progressors (those who declined more than 1.1 point per month on the revised ALS Functional Rating Scale) and normal progressors. About 85 percent of the participants were normal progressors. Among this group, those taking 4.5 mg/kg masitinib declined 3.4 points less on the ALSFRS-R than the placebo group over the course of the study. This translated to 27 percent less functional decline over this time period, a clinically meaningful difference, according to Jesus Mora at Hospital Carlos III in Madrid, who presented the clinical trial findings at ENCALS. Treated participants maintained greater lung capacity and reported better quality of life than the placebo group. They lasted 20 months before their disease progressed nine points or more on the ALSFRS-R, compared with 16 months for those on placebo. Participants who took the lower 3 mg/kg dose also reported better quality of life, but their trend toward slower functional decline did not reachsignificance.

Other data hinted that the drug was most effective when given at an early stage of disease. When normal and fast progressors were combined, the 4.5 mg/kg dose only slowed decline in those who had had the disease for less than two years. Fast progressors may need earlier treatment, Morasuggested.

The safety profile was acceptable, with no surprises cropping up, the researchers said. The treatment group experienced more serious adverse events than the placebo group. These were scattered across different organ systems and did not fall into any pattern. For oncology use, tyrosine kinase inhibitors are normally given at higher doses, from 6 to 12 mg/kg, with no serious safety issues, the researchers noted.Madolyn BowmanRogers

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May 26, 2017 14:28 ET | Source: Center for the Advancement of Science in Space

Kennedy Space Center, FL, May 26, 2017 (GLOBE NEWSWIRE) -- The SpaceX Falcon 9 vehicle is slated to launch its 11thcargo resupply mission (CRS-11) to the International Space Station (ISS) no earlier than June 1, 2017 from Kennedy Space Center Launch Complex 39A. Onboard the Falcon 9 launch vehicle is the SpaceX Dragon spacecraft, which will carry more than 40 ISS U.S. National Laboratory sponsored experiments. This mission will showcase the breadth of research possible through the ISS National Laboratory, as experiments range from the life and physical sciences, Earth observation and remote sensing, and a variety of student-led investigations. Below highlights the investigations as part of the SpaceX CRS-11 mission:

ADVANCED COLLOIDS EXPERIMENT-TEMPERATURE CONTROLLED-6 (ACE-T-6)

Matthew Lynch, Procter & Gamble (West Chester, OH)

Implementation Partner: NASA Glenn Research Center and Zin Technologies, Inc.

Colloids are suspensions of microscopic particles in a liquid, and they are found in products ranging from milk to fabric softener. Consumer products often use colloidal gels to distribute specialized ingredients, for instance droplets that soften fabrics, but the gels must serve two opposite purposes: they have to disperse the active ingredient so it can work, yet maintain an even distribution so the product does not spoil. Advanced Colloids Experiment-Temperature-6 (ACE-T-6) studies the microscopic behavior of colloids in gels and creams, providing new insight into fundamental interactions that can improve product shelf life.

EFFICIENCY OF VERMICOMPOSTING IN A CLOSED SYSTEM (NANORACKS-NDC-BMS-VERICOMPOSTING)

Bell Middle School (Golden, CO)

Implementation Partner: NanoRacks

Vermicomposting, or using worms to break down food scraps, is an effective way to reduce waste and obtain a nutrient-rich fertilizer for plants. The NanoRacks-NDC-Bell Middle School-Efficiency of Vermicomposting in a Closed System (NanoRacks-NDC-BMS-Vermicomposting) investigation is a student-designed project that studies whether red wiggler worms, a species of earthworm, are able to produce compost in space. Results are used to study the potential for composting as a form of recycling on future long-duration space missions.

FUNCTIONAL EFFECTS OF SPACEFLIGHT ON CARDIOVASCULAR STEM CELLS (CARDIAC STEM CELLS)

Dr. Mary Kearns-Jonker, Loma Linda University (Loma Linda, CA)

Implementation Partner: BioServe Space Technologies

Functional Effects of Spaceflight on Cardiovascular Stem Cells (Cardiac Stem Cells) investigates how microgravity alters stem cells and the factors that govern stem cell activity, including physical and molecular changes. Spaceflight is known to affect cardiac function and structure, but the biological basis for this is not clearly understood. This investigation helps clarify the role of stem cells in cardiac biology and tissue regeneration. In addition, this research could confirm the hypothesis that microgravity accelerates the aging process.

MULTIPLE USER SYSTEM FOR EARTH SENSING (MUSES)

Paul Galloway, Teledyne Brown Engineering (Huntsville, AL)

Implementation Partner: Teledyne Brown Engineering

Teledyne Brown Engineering developed the Multiple User System for Earth Sensing (MUSES), an Earth imaging platform, as part of the companys new commercial space-based digital imaging business. MUSES hosts earth-viewing instruments (Hosted Payloads), such as high resolution digital cameras, hyperspectral imagers, and provides precision pointing and other accommodations. It hosts up to four instruments at the same time, and offers the ability to

change, upgrade, and robotically service those instruments. It also provides a test bed for technology demonstration and technology maturation by providing long-term access to the space environment on the ISS.

NANORACKS-JAMSS-2LAGRANGE-1

Tomohiro Ichikawa, Lagrange Corp. (Tokyo, Japan)

Implementation Partner: NanoRacks

Spaceflight affects organisms in a wide range of ways, from a reduction in human bone density to changes in plant root growth. NanoRacks-JAMSS-2 Lagrange-1 helps students understand potential spaceflight-related changes by exposing plant seeds to microgravity, and then germinating and growing them on Earth. The plants are compared with specimens grown from seeds that remained on the ground. The investigation also connects students to the space program by sending their photographic likenesses and personal messages into orbit. This connection inspires the next generation of scientists and engineers who will work on international space programs.

NEUTRON CRYSTALLOGRAPHIC STUDIES OF HUMAN ACETYLCHOLINESTERASE FOR THE DESIGN OF ACCERERATED REACTIVATORS (ORNL-PCG)

Dr. Andrey Kovalevsky, Oak Ridge National Laboratory (Oak Ridge, TN)

Implementation Partner: CASIS

The investigative team is trying to improve our understanding of acetylcholinesterase, an enzyme essential for normal communication between nerve cells and between nerve and muscle cells. As a target of deadly neurotoxins produced by animals as venom or by man as nerve agents and pesticides, understanding the structure of acetylcholinesterase is critical to designing better antidotes to poisoning by chemicals that attack the nervous system. The Oak Ridge National Lab team plans to use the microgravity environment of space to grow large crystals of the enzyme that will be imaged back on Earth using a powerful imaging approach called neutron diffraction. Neutron diffraction yields very detailed structural information but requires much larger crystals than traditional x-ray diffraction imaging methods. The investigators hypothesize that structural images of space-grown crystals will bring us closer to more effective and less toxic antidotes for neurotoxins that bind and inhibit acetylcholinesterase.

STUDENT SPACEFLIGHTS EXPERIMENT PROGRAM MISSION 10

Dr. Jeff Goldstein, National Center for Earth and Space Science Education (Washington, D.C.)

Implementation Partner: NanoRacks

The Student Spaceflight Experiments Program (SSEP) provides one of the most exciting educational opportunities available: student-designed experiments to be flown on the International Space Station. The NanoRacks-National Center for Earth and Space Science Education-Odyssey (NanoRacks-NCESSE-Odyssey) investigation contains 24 student experiments, including microgravity studies of plant, algae and bacterial growth; polymers; development of multi-cellular organisms; chemical and physical processes; antibiotic efficacy; and allergic reactions. The program immerses students and teachers in real science, providing first-hand experience conducting scientific experiments and connecting them to the space program.

SYSTEMIC THERAPY OF NELL-1 FOR OSTEOPOROSIS (RODENT RESEARCH-5)

Dr. Chia Soo, University of California at Los Angeles (Los Angeles, CA)

Implementation Partner: NASA Ames Research Center and BioServe Space Technologies

Astronauts living in space for extended durations experience bone density loss, or osteoporosis. Currently, countermeasures include daily exercise designed to prevent bone loss from rapid bone density loss deterioration. However, in space and on Earth, therapies for osteoporosis cannot restore bone that is already lost. The Systemic Therapy of NELL-1 for Osteoporosis (Rodent Research-5) investigation tests a new drug on rodents that can both rebuild bone and block further bone loss, improving health for crew members in orbit and people on Earth. Dr. Soos laboratory has been funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases within the National Institutes of Health. This experiment builds on those previous research investigations.

THE EFFECT OF MICROGRAVITY ON TWO STRAINS OF BIOFUEL PRODUCING ALGAE WITH IMPLICATIONS FOR THE PRODUCTION OF RENEWABLE FUELS IN SPACE-BASED APPLICATIONS

Chatfield High School (Littleton, CO)

Implementation Partner: NanoRacks

Algae can produce both fats and hydrogen, which can each be used as fuel sources on Earth and potentially in space. NanoRacks-National Design Challenge-Chatfield High School-The Effect of Microgravity on Two Strains of Biofuel Producing Algae with Implications for the Production of Renewable Fuels in Space Based Applications (NanoRacks-NDC-CHS-The Green Machine) studies two algae species to determine whether they still produce hydrogen and store fats while growing in microgravity. Results from this student-designed investigation improve efforts to produce a sustainable biofuel in space, as well as remove carbon dioxide from crew quarters.

TOMATOSPHERE-II

Ann Jorss, First the Seed Foundation (Alexandria, VA)

Implementation Partner: CASIS

Tomatosphere is a hands-on student research experience with a standards-based curriculum guide that provides students the opportunity to investigate, create, test, and evaluate a solution for a real world case study. Tomatosphere provides information about how spaceflight affects seed and plant growth and which type of seed is likely to be most suitable for long duration spaceflight. It also exposes students to space research, inspiring the next generation of space explorers. It is particularly valuable in urban school settings where students have little connection to agriculture. In its 15-year existence, the program has reached approximately 3.3 million students.

VALLEY CHRISTIAN HIGH SCHOOL STUDENT EXPERIMENTS

Valley Christian High School (San Jose, CA), in partnership with other high schools throughout the world

Implementation Partner: NanoRacks

Students at Valley Christian High School (VCHS) have a rich history of sending investigations to the ISS through its launch partner, NanoRacks. On SpaceX CRS-11, students from VCHS have partnered with other students from across the world to send 12 total experiments to the ISS National Laboratory. Investigations will range from investigating high quality food nutrients, to the fermentation of microbes, to even an investigation monitoring the growth of a special bacterial strain. The program VCHS has developed with NanoRacks allows students the opportunity to not only conceive a flight project, but learn, understand, and implement the engineering required for a successful experiment in microgravity.

Thus far in 2017, the ISS National Lab has sponsored over 75 separate experiments that have reached the station. This launch manifest adds to an impressive list of experiments from previous missions in 2017 to include; stem cell studies, cell culturing, protein crystal growth, external platform payloads, student experiments, Earth observation and remote sensing. To learn more about those investigations and other station research, visit http://www.spacestationresearch.com.

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About CASIS: The Center for Advancement of Science in Space (CASIS) is the non-profit organization selected to manage the ISS National Laboratory with a focus on enabling a new era of space research to improve life onEarth. In this innovative role, CASIS promotes and brokers a diverse range of research inlife sciences,physical sciences,remote sensing,technology development,andeducation.

Since 2011, the ISS National Lab portfolio has included hundreds of novel research projects spanning multiple scientific disciplines, all with the intention of benefitting life on Earth.. Working together with NASA, CASIS aims to advance the nations leadership in commercial space, pursue groundbreaking science not possible on Earth, and leverage the space station to inspire the next generation.

About the ISS National Laboratory: In 2005, Congress designated the U.S. portion of the International Space Station as the nation's newest national laboratory to maximize its use for improving life on Earth, promoting collaboration among diverse users, and advancing STEM education. This unique laboratory environment is available for use by other U.S. government agencies and by academic and private institutions, providing access to the permanent microgravity setting, vantage point in low Earth orbit, and varied environments of space.

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Over 40 U.S. National Laboratory Sponsored Experiments on SpaceX CRS-11 Destined for the International Space ... - GlobeNewswire (press release)

Cardiac Stem Cells Comments Off on Over 40 U.S. National Laboratory Sponsored Experiments on SpaceX CRS-11 Destined for the International Space … – GlobeNewswire (press release) | May 27th, 2017

The late actor Telly Savalas said it best: Were all born bald, baby.

And bald CAN be beautiful.

But for many follicly-challenged folks, news out of UC San Francisco this week offers some hope of finally having a bad hair day.

In experiments in mice, researchers there have discovered that regulatory T cells (Tregs; pronounced tee-regs), a type of immune cell associated with controlling inflammation, directly trigger stem cells in the skin to promote healthy hair growth.

Without these immune cells as partners, the researchers found, the stem cells cannot regenerate hair follicles, leading to baldness.

Our hair follicles are constantly recycling: when a hair falls out, the whole hair follicle has to grow back, said Dr. Michael Rosenblum, an assistant professor of dermatology at UCSF and senior author on the new paper.

This has been thought to be an entirely stem cell-dependent process, but it turns out Tregs are essential. If you knock out this one immune cell type, hair just doesnt grow.

In other words: no Tregs, no tresses.

The new study appeared online Friday in Cell, a journal that publishes peer-reviewed articles reporting findings of unusual significance in any area of experimental biology.

For 35 million U.S. men and 21 million women who are experiencing hair loss, according to Statistic Brain Research Institute,the UCSF report would probably qualify as significant.

The study suggests that defects in Tregs could be responsible for alopecia areata, a common autoimmune disorder that causes hair loss, and could potentially play a role in other forms of baldness, including male pattern baldness, Rosenblum said.

And since the same stem cells are responsible for helping heal the skin after injury, the researchers note, the study raises the possibility that Tregs may play a key role in wound repair as well.

Normally, the researchers say, Tregs act as peacekeepers and diplomats, informing the rest of the immune system of the difference between friend and foe. When Tregs dont function properly, people may develop allergies to harmless substances like peanut protein or cat dander, or suffer from autoimmune disorders in which the immune system turns on the bodys own tissues.

Like other immune cells, most Tregs reside in the bodys lymph nodes, but some live permanently in other tissues, where researcher say they seem to have evolved to assist with local metabolic functions as well as playing their normal anti-inflammatory role. In the skin, for example, Rosenblum and colleagues have previously shown that Tregs help establish immune tolerance to healthy skin microbes in newborn mice, and these cells also secrete molecules that help heal wounds into adulthood.

Rosenblum wanted to better understand the role of these resident immune cells in skin health. To do this, he and his team developed a technique for temporarily removing Tregs from the skin. But when they shaved patches of hair from these mice to make observations of the affected skin, they made a surprising discovery.

We quickly noticed that the shaved patches of hair never grew back, and we thought, Hmm, now thats interesting, Rosenblum said. We realized we had to delve into this further.

The researchers including UCSF postdoctoral fellow and first author Niwa Ali believe a betterunderstanding of Tregs critical role in hair growth could lead to improved treatments for hair loss more generally and have implications for alopecia areata, an autoimmune disease that causes patients to lose hair in patches from their scalp, eyebrows, and faces.

For many other baldly confident folks, however, Fridays findings may just warrant a shrug.As they say, No hair, dont care.

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Currently, there are only 11 hospitals that are authorized to give stem cell treatments in Indonesia. (Shutterstock/File)

Developments in science and technology have enabled humankind to achieve the unthinkable, including advancements in healthcare. In the next 10 years, patients may not even need medicine to cure certain illnesses as reported by kompas.com.

Principal investigator of Stem Cell and Cancer Institute, Dr. Yuyus Kusnadi, said health scientists are developing stem cell treatments. Stem cells are cells with the ability to renew or regenerate any kind of cells.

Degenerative conditions such as kidney failure and the weakening of heart muscles in the future may be cured by injecting stem cells into the patients body.

Stem cells can be obtained from umbilical cord blood that is kept in a stem cell bank, back bone marrow and fat. However, fat and bone marrow will decline in quality as a person grows older. Stem cells stored in a stem cell bank can be used for future treatments if needed.

Read also: Scientists take first steps to growing human organs in pigs

Health treatments using stem cells exist today although they are not yet developed due to limitations in funding and technology. Yuyus said in Indonesia, those who are allowed stem cell treatment are those who have no option.

For now, stem cell treatment require a doctors approval. Its still subjective, he said.

For those with recommendations for stem cell treatment, the stem cell is obtained from blood or fat. Manipulation in the laboratory is needed to strengthen the stem cell.

Although stem cell treatments are not yet popular these days, Yuyus is optimistic, Lets wait five to ten more years. The current use of medicine only stops symptoms and does not fix the sickness, he said.

Stem cell treatments will not be cheap either, as it will cost patients up to hundreds of millions of rupiah.

Currently, there are only 11 hospitals that are authorized to give stem cell treatments in Indonesia. The hospitals right to provide stem cell treatments is regulated in the Health Ministers Regulation no. 32, 2014 on the Incorporation of Medical Research Service and Education of Tissue and Stem Cell Centers.

Hospitals authorized to provide stem cell treatments in Indonesia include Rumah Sakit Cipto Mangun Kusumo, RS. Sutomo, RS M. Djamil, RS. Persahabatan, RS. Fatmawati, RS. Dharmais, RS. Harapan Kita, RS. Hasan Sadikin, RS. Kariadi, RS. Sardjito and RS. Sanglah. (asw)

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Stem cell treatments ready to replace medicine in 10 years: Expert - Jakarta Post

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UCalgary researchers identify 'signal' crucial to stem cell function in hair follicles UCalgary News This is the first study to identify the signals that influence hair follicle dermal stem cell function in your skin, says Biernaskie, an associate professor in comparative biology and experimental medicine at the University of Calgary's Faculty of ... and more »

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knowledge center home stem cell research all about stem cells what are stem cells?

Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. Commonly, stem cells come from two main sources:

Both types are generally characterized by their potency, or potential to differentiate into different cell types (such as skin, muscle, bone, etc.).

Adult or somatic stem cells exist throughout the body after embryonic development and are found inside of different types of tissue. These stem cells have been found in tissues such as the brain, bone marrow, blood, blood vessels, skeletal muscles, skin, and the liver. They remain in a quiescent or non-dividing state for years until activated by disease or tissue injury.

Adult stem cells can divide or self-renew indefinitely, enabling them to generate a range of cell types from the originating organ or even regenerate the entire original organ. It is generally thought that adult stem cells are limited in their ability to differentiate based on their tissue of origin, but there is some evidence to suggest that they can differentiate to become other cell types.

Embryonic stem cells are derived from a four- or five-day-old human embryo that is in the blastocyst phase of development. The embryos are usually extras that have been created in IVF (in vitro fertilization) clinics where several eggs are fertilized in a test tube, but only one is implanted into a woman.

Sexual reproduction begins when a male's sperm fertilizes a female's ovum (egg) to form a single cell called a zygote. The single zygote cell then begins a series of divisions, forming 2, 4, 8, 16 cells, etc. After four to six days - before implantation in the uterus - this mass of cells is called a blastocyst. The blastocyst consists of an inner cell mass (embryoblast) and an outer cell mass (trophoblast). The outer cell mass becomes part of the placenta, and the inner cell mass is the group of cells that will differentiate to become all the structures of an adult organism. This latter mass is the source of embryonic stem cells - totipotent cells (cells with total potential to develop into any cell in the body).

In a normal pregnancy, the blastocyst stage continues until implantation of the embryo in the uterus, at which point the embryo is referred to as a fetus. This usually occurs by the end of the 10th week of gestation after all major organs of the body have been created.

However, when extracting embryonic stem cells, the blastocyst stage signals when to isolate stem cells by placing the "inner cell mass" of the blastocyst into a culture dish containing a nutrient-rich broth. Lacking the necessary stimulation to differentiate, they begin to divide and replicate while maintaining their ability to become any cell type in the human body. Eventually, these undifferentiated cells can be stimulated to create specialized cells.

Stem cells are either extracted from adult tissue or from a dividing zygote in a culture dish. Once extracted, scientists place the cells in a controlled culture that prohibits them from further specializing or differentiating but usually allows them to divide and replicate. The process of growing large numbers of embryonic stem cells has been easier than growing large numbers of adult stem cells, but progress is being made for both cell types.

Once stem cells have been allowed to divide and propagate in a controlled culture, the collection of healthy, dividing, and undifferentiated cells is called a stem cell line. These stem cell lines are subsequently managed and shared among researchers. Once under control, the stem cells can be stimulated to specialize as directed by a researcher - a process known as directed differentiation. Embryonic stem cells are able to differentiate into more cell types than adult stem cells.

Stem cells are categorized by their potential to differentiate into other types of cells. Embryonic stem cells are the most potent since they must become every type of cell in the body. The full classification includes:

Embryonic stem cells are considered pluripotent instead of totipotent because they do not have the ability to become part of the extra-embryonic membranes or the placenta.

A video on how stem cells work and develop.

Although there is not complete agreement among scientists of how to identify stem cells, most tests are based on making sure that stem cells are undifferentiated and capable of self-renewal. Tests are often conducted in the laboratory to check for these properties.

One way to identify stem cells in a lab, and the standard procedure for testing bone marrow or hematopoietic stem cell (HSC), is by transplanting one cell to save an individual without HSCs. If the stem cell produces new blood and immune cells, it demonstrates its potency.

Clonogenic assays (a laboratory procedure) can also be employed in vitro to test whether single cells can differentiate and self-renew. Researchers may also inspect cells under a microscope to see if they are healthy and undifferentiated or they may examine chromosomes.

To test whether human embryonic stem cells are pluripotent, scientists allow the cells to differentiate spontaneously in cell culture, manipulate the cells so they will differentiate to form specific cell types, or inject the cells into an immunosuppressed mouse to test for the formation of a teratoma (a benign tumor containing a mixture of differentiated cells).

Scientists and researchers are interested in stem cells for several reasons. Although stem cells do not serve any one function, many have the capacity to serve any function after they are instructed to specialize. Every cell in the body, for example, is derived from first few stem cells formed in the early stages of embryological development. Therefore, stem cells extracted from embryos can be induced to become any desired cell type. This property makes stem cells powerful enough to regenerate damaged tissue under the right conditions.

Tissue regeneration is probably the most important possible application of stem cell research. Currently, organs must be donated and transplanted, but the demand for organs far exceeds supply. Stem cells could potentially be used to grow a particular type of tissue or organ if directed to differentiate in a certain way. Stem cells that lie just beneath the skin, for example, have been used to engineer new skin tissue that can be grafted on to burn victims.

A team of researchers from Massachusetts General Hospital reported in PNAS Early Edition (July 2013 issue) that they were able to create blood vessels in laboratory mice using human stem cells.

The scientists extracted vascular precursor cells derived from human-induced pluripotent stem cells from one group of adults with type 1 diabetes as well as from another group of healthy adults. They were then implanted onto the surface of the brains of the mice.

Within two weeks of implanting the stem cells, networks of blood-perfused vessels had been formed - they lasted for 280 days. These new blood vessels were as good as the adjacent natural ones.

The authors explained that using stem cells to repair or regenerate blood vessels could eventually help treat human patients with cardiovascular and vascular diseases.

Additionally, replacement cells and tissues may be used to treat brain disease such as Parkinson's and Alzheimer's by replenishing damaged tissue, bringing back the specialized brain cells that keep unneeded muscles from moving. Embryonic stem cells have recently been directed to differentiate into these types of cells, and so treatments are promising.

Healthy heart cells developed in a laboratory may one day be transplanted into patients with heart disease, repopulating the heart with healthy tissue. Similarly, people with type I diabetes may receive pancreatic cells to replace the insulin-producing cells that have been lost or destroyed by the patient's own immune system. The only current therapy is a pancreatic transplant, and it is unlikely to occur due to a small supply of pancreases available for transplant.

Adult hematopoietic stem cells found in blood and bone marrow have been used for years to treat diseases such as leukemia, sickle cell anemia, and other immunodeficiencies. These cells are capable of producing all blood cell types, such as red blood cells that carry oxygen to white blood cells that fight disease. Difficulties arise in the extraction of these cells through the use of invasive bone marrow transplants. However hematopoietic stem cells have also been found in the umbilical cord and placenta. This has led some scientists to call for an umbilical cord blood bank to make these powerful cells more easily obtainable and to decrease the chances of a body's rejecting therapy.

Another reason why stem cell research is being pursued is to develop new drugs. Scientists could measure a drug's effect on healthy, normal tissue by testing the drug on tissue grown from stem cells rather than testing the drug on human volunteers.

The debates surrounding stem cell research primarily are driven by methods concerning embryonic stem cell research. It was only in 1998 that researchers from the University of Wisconsin-Madison extracted the first human embryonic stem cells that were able to be kept alive in the laboratory. The main critique of this research is that it required the destruction of a human blastocyst. That is, a fertilized egg was not given the chance to develop into a fully-developed human.

The core of this debate - similar to debates about abortion, for example - centers on the question, "When does life begin?" Many assert that life begins at conception, when the egg is fertilized. It is often argued that the embryo deserves the same status as any other full grown human. Therefore, destroying it (removing the blastocyst to extract stem cells) is akin to murder. Others, in contrast, have identified different points in gestational development that mark the beginning of life - after the development of certain organs or after a certain time period.

People also take issue with the creation of chimeras. A chimera is an organism that has both human and animal cells or tissues. Often in stem cell research, human cells are inserted into animals (like mice or rats) and allowed to develop. This creates the opportunity for researchers to see what happens when stem cells are implanted. Many people, however, object to the creation of an organism that is "part human".

The stem cell debate has risen to the highest level of courts in several countries. Production of embryonic stem cell lines is illegal in Austria, Denmark, France, Germany, and Ireland, but permitted in Finland, Greece, the Netherlands, Sweden, and the UK. In the United States, it is not illegal to work with or create embryonic stem cell lines. However, the debate in the US is about funding, and it is in fact illegal for federal funds to be used to research stem cell lines that were created after August 2001.

Medical News Today is a leading resource for the latest headlines on stem cell research. So, check out our stem cell research news section. You can also sign up to our weekly or daily newsletters to ensure that you stay up-to-date with the latest news.

This stem cells information section was written by Peter Crosta for Medical News Today in September 2008 and was last updated on 19 July 2013. The contents may not be re-produced in any way without the permission of Medical News Today.

Disclaimer: This informational section on Medical News Today is regularly reviewed and updated, and provided for general information purposes only. The materials contained within this guide do not constitute medical or pharmaceutical advice, which should be sought from qualified medical and pharmaceutical advisers.

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MIAMI, May 22, 2017 /PRNewswire/ -- Longeveron announced receiving a $750,000 grant from the Maryland Stem Cell Research Fund (MSCRF) to continue groundbreaking stem cell research. Longeveron, a Miami based regenerative medicine company, will partner with the University of Maryland and Johns Hopkins University to conduct a clinical trial for Hypoplastic Left Heart Syndrome (HLHS), a rare and often fatal condition in infants caused by an underdeveloped heart.

According to Dr. Sunjay Kaushal, Director of Pediatric Cardiac Surgery at University of Maryland, and Site Investigator on this award, "We anticipate that the HLHS trial may be a game changing procedure to improve the ventricular performance for these HLHS babies that will improve their outcomes and allow them to live longer lives."

The MSCRF was established by the Governor and the Maryland General Assembly through the Maryland Stem Cell Research Act of 2006 to accelerate research using human stem cells and advance medical treatment. In a May 10 news release, Rabbi Avram Reisner, Chair of the Maryland Stem Cell Research Commission noted, "The awards announced are the first in our new Accelerating Cure initiative. They represent some of the most advanced regenerative medicine projects that are being undertaken. These awardees are at the leading edge of medical innovation and exemplify the purpose and mission of the Maryland Stem Cell Research Fund."

Longeveron Co-Founder & Chief Science Officer, Joshua M. Hare, M.D., who will serve as the Principal Investigator on this award stated, "Longeveron is honored to receive this competitive award from MSCRF to continue this important research to treat this life-threatening condition affecting infants."

About Longeveron Longeveron is a regenerative medicine therapy company founded in 2014. Longeveron's goal is to provide the first of its kind biological solution for aging-related diseases, and is dedicated to developing safe cell-based therapeutics to revolutionize the aging process and improve quality of life. The company's research focus areas include Alzheimer's disease, Aging Frailty and the Metabolic Syndrome. Longeveron produces LMSCs in its own state-of-the-art cGMP cell processing facility. http://www.longeveron.com

Contact: Suzanne Liv Page spage@longeveron.com 305.909.0850

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/longeveron-to-receive-grant-from-the-maryland-stem-cell-research-fund-300461323.html

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Back to Browse Journals Clinical Ophthalmology Volume 11

Carina Costa Cotrim, Luiza Toscano, Andr Messias, Rodrigo Jorge, Rubens Camargo Siqueira

Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, Ribeirao Preto School of Medicine, University of Sao Paulo, Sao Paulo, Brazil

Purpose: To evaluate the therapeutic potential and safety of intravitreal injections of bone marrow mononuclear fraction (BMMF) containing CD34+ cells in patients with atrophic age-related macular degeneration (AMD). Methods: Ten patients with atrophic AMD and best-corrected visual acuity (BCVA) in the worse-seeing eye of 20/100 were enrolled in this study. The bone marrow from all patients was aspirated and processed for mononuclear cell separation. A 0.1mL suspension of BMMF CD34+ cells was injected into the vitreous cavity of the worse-seeing eye. Patients were evaluated at Baseline and 1,3,6,9 and 12 months after injection. Ophthalmic evaluation included BCVA measurement, microperimetry, infrared imaging, fundus autofluorescence and SD-optical coherence tomography at all study visits. Fluorescein angiography was performed at Baseline and at 6and 12 months after intravitreal therapy. Results: All patients completed the 6-month follow-up, and six completed the 12-month follow-up. Prior to the injection, mean BCVA was 1.18 logMAR (20/320-1), ranging from 20/125 to 20/640-2, and improved significantly at every follow-up visit, including the 12-month one, when BCVA was 1.0 logMAR (20/200) (P<0.05). Mean sensitivity threshold also improved significantly at 6, 9 and 12 months after treatment (P<0.05). Considering the area of atrophy identified by fundus autofluorescence, significant mean BCVA and mean sensitivity threshold improvement were observed in patients with the smallest areas of atrophy. Fluorescein angiography did not identify choroidal new vessels or tumor growth. Conclusion: The use of intravitreal BMMF injections in patients with AMD is safe and is associated with significant improvement in BCVA and macular sensitivity threshold. Patients with small areas of atrophy have a better response. The paracrine effect of CD34+ cells may explain the functional improvement observed; however, larger series of patients are necessary to confirm these preliminary findings. Keywords: AMD, stem cells, hematopoietic cells

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Science World Report

Bone Marrow Stem Cell Transplants Could Advance ALS Treatment Science World Report The researchers discovered that bone marrow stem cell transplants may advance the treatment of the disease amyotrophic lateral sclerosis (ALS). The transplants enhanced the motor functions and nervous system conditions in mice with ALS that modeled in ... Stem cell transplants beneficial to mice with ALSLife Science Daily all 2 news articles »

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Published online 22 May 2017

Two teams of Arab and American researchers are tantalizingly close to generating primordial blood stem cells in the lab.

Louise Sarant

Hematopoietic stem and progenitor cells (HSPC) from human iPS cells. Rio Sugimura Two teams of scientists have developed methods that make lab-grown blood stem cells a realistic prospect a goal for hematology researchers since human embryonic stem (ES) cells were first isolated in 1998.

Scientists have previously succeeded in genetically reprogramming skin cells to make pluripotent stem (iPS) cells, which are later used to generate multiple human cell types. However, the ability to induce blood stem cells that self-regenerate, for the treatment of millions affected by blood cancers and genetic disorders, has eluded researchers.

The two papers newly published in Nature describe methods that pave the way for safe, artificial and bona fide hematopoietic stem cells (HSCs) generation. Hematopoietic stem (HSC) cells are the common ancestor of all cells created in the body, producing billions of blood cells every day.

This bears major implications for cell therapy, drug screening and leukemia research. The root causes of blood diseases can be scrutinized and creating immune-matched blood cells, derived from a patients own cells, is now conceivable.

The first team, based at the Boston Childrens Hospital, has generated blood-forming stem cells (HSCs) in the lab using pluripotent stem cells for the first time.

Were tantalizingly close to generating bona fide human blood stem cells in a dish, says senior investigator George Daley, who heads the research lab in Boston Childrens Hospitals stem cell program and who is dean of Harvard Medical School. This work is the culmination of over 20 years of striving.

Ryohichi Rio Sugimura, the studys first author and a postdoctoral fellow in the Daley Lab, says his team exposed human pluripotent stem cells (both ES and iPS cells) to chemical signals to prompt them to differentiate into specialized cells and tissues during embryonic development.

"Sugimura and his colleagues delivered transcription factors proteins that control and regulate the transcription of specific genes into the cells using a lentivirus, a vector to deliver genes. The resultant cells were transplanted to immune deficient mice, where human blood and immune cells were made, he says.

A few weeks after the transplant, a small number of rodents were found to be carrying multiple types of blood cells in their bone marrow and blood; cells that are also found in human blood. This is a major step forward for our ability to investigate genetic blood disease, says Daley.

The second team, a group of scientists from Weill Cornell Qatar and Weill Cornell Medicine in New York, used mature mouse endothelial cells cells that line blood vessels as their starting material for generating HSCs.

Image of human CD45+ blood cells differentiated from iPS cells. Rio Sugimura Based on previous work, we hypothesized that endothelial cells are the mastermind of organ development, explains Jeremie Arash Rafii Tabrizi, paper co-author and researcher at the stem cell and microenvironment laboratory at Weill Cornell Medicine, Qatar.

The team isolated the cells, and then pushed key transcription factors into their genomes. Between days 8 and 20 into the process, the cells specified and multiplied.

Our research showed that endothelial cells can be converted into competent HSCs with the ability to both regenerate the myeloid and lymphoid lineage, he explains.

The method brings hope for people afflicted with leukemia requiring HSCs transplantation, or genetic disorders affecting the myeloid or lymphoid lineages. The clinical generation of HSCs, derived from the same individual, can eventually help scientists correct genetic abnormalities.

As exciting as the two studies are, rigorous tests are still required to check the normality of lab-grown cells before the clinical phase, says Alexander Medvinsky, professor of hematopoietic stem cell biology at the University of Edinburgh Medical Research Council Centre for Regenerative Medicine. Medvinsky was not involved in either study.

The risks of infusion of genetically engineered cells in humans should not be underestimated, he weighs in. Tests and trials to generate safe fully functional human blood stem cells may take many years, in contrast to similar assessment in short-living mice. It is not clear now whether blood stem cells can become cancerous in the longer term.

He adds however that this type of research is exactly what is required to potentially meet clinical needs.

doi:10.1038/nmiddleeast.2017.89

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By Anette Breindl Senior Science Editor

"With the advent of targeted cancer therapies, what we've found is that many of them are cardiotoxic," Saptarsi Haldar told BioWorld Today. "Pathways that are effective in cancer are toxic in the heart."

In the May 17, 2017, issue of Science Translational Medicine, Haldar, who is an associate investigator at the Gladstone Institute of Cardiovascular Disease, and his colleagues showed that a class of epigenetic drugs, the BET bromodomain inhibitors, may be not just an exception to that rule, but a class of drugs that has therapeutic utility in heart failure.

The team showed that the bromodomain inhibitor JQ-1 had therapeutic benefits in two separate animal models of advanced heart failure, but did not affect the beneficial changes to heart muscle cells that are a consequence of exercise.

The paper shows a potential new approach to heart failure an indication that, with a five-year survival rate of 60 percent, needs them.

It also shows a potential approach to another vexing problem, namely drugging transcription factors.

"There's a surprisingly tractable therapeutic index for drugging transcription in diseases," Haldar said.

While BRD4 is not itself a transcription factor, inhibiting it "dampens the transcription factor-driven network that's driving the disease . . . This is really about dampening transcriptional rewiring," he added.

In heart failure, those happen to be innate immune signaling and fibrotic signaling. Experiments in cardiac cells derived from induced pluripotent stem cells (iPSCs) showed that JQ-1 acted by blocking the activation of innate immune and profibrotic pathways, essentially preventing heart cells from rewiring themselves in maladaptive ways in response to being chronically overworked.

Haldar said the original idea to test whether the compound would have an effect in heart failure was based on "an educated guess."

Previous work had shown that certain epigenetic marks, namely acetyl marks on lysines, play a role in heart failure.

"There is a lot known about lysine acetylation in heart failure," Haldar said, and there had been previous attempts at targeting the process, which had "fallen to the wayside, in part because of issues with therapeutic index."

Even studying the molecular details of lysine acetylation's role in heart failure was challenging, because genetic approaches are not viable.

The problem became tractable with the synthesis of JQ-1 in the laboratory of James Bradner, who is a co-author on the Science Translational Medicine paper. The compound, which has been used to gain insight into epigenetic aspects of a large number of biological processes thanks to the decision of its developers to distribute it freely, targets BRD4, a "reader" protein that recognizes acetylated lysines. (See BioWorld Insight, Aug. 12, 2013.)

With the advent of JQ-1, Haldar said, "we immediately made the connection that here's a target BRD4 that you could specifically modulate that is recognizing acetyl-lysines on chromatin."

The team initially published work in 2013 showing that JQ-1 affected cellular processes in heart failure, and was an effective therapeutic in mice when given very early in the disease.

Patients, though, don't show up in their doctor's office very early in the disease. They show up with "pre-existing, often chronic heart failure," Haldar said.

At that point, the heart has already undergone significant remodeling that includes fibrosis and an activation of innate immune pathways.

The work now published in Science Translational Medicine showed that JQ-1 had effects even when given to mice that had established heart failure either due to a heart attack, or pressure overload, but did not block exercise-induced remodeling.

The team is hoping to test JQ-1 derivatives in large animal models, and ultimately take them into the clinic. Haldar is a co-founder of Tenaya Therapeutics Inc., a company launched in December with a $50 million series A financing from The Column Group. Haldar said that while he holds a patent on BET protein inhibition in heart disease, BET proteins are only "one of many targets/pathways that Tenaya is considering."

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Its one of those times when serendipity went to work. As a team of UT Southwestern Medical Center researchers were studying a rare form of genetic cancer called Neurofibromatosis Type 1 that causes tumors to grow on nerves, what they discovered instead were hair progenitor cells. Essentially, these are the cells that cause hair to grow. With this new information on hand, the path towards managing hair growth problems, including hair discoloration (a.k.a greying of hair) now seems to have become clearer.

As explained by Dr. Lu Le, one of the researchers and currently an Associate Professor of Dermatology: With this knowledge, we hope in the future to create a topical compound or to safely deliver the necessary gene to hair follicles to correct these cosmetic problems.

Prior to this discovery, researchers were already aware that skin stem cells located in the bulge on bottom of hair follicles were involved, in one way or another, in the growth of hair. What they didnt know was how these skin cells turn into hair cells, specifically, what happens after those cells move down to the bulb or the base of hair follicles. This also meant they had no idea what to do to stimulate and manipulate their growth.

As they were studying the nerve cells and how tumors formed on them, they discovered a protein that differentiates the skin stem cells from other types of cells. The protein is called KROX20 and as far as they knew, this protein was more commonly associated with nerve development. In the hair follicles of their mice test subjects, however, they found out that KROX20 becomes activated in the skin cells which eventually turn into hair shafts that cause hair to grow. That said, though, its not as simple as that.

It turned out that KROX20 works in tandem with another protein called SCF (short for stem cell factor) and without either one, hair growth happens abnormally, or not at all.

When KROX20 turns on in a skin cell, it causes the cell to produce SCF. With both proteins now active, they move up the hair bulb, interact with melanocyte cells (the cells that produce pigment), and grow into healthy, colored hairs.

When the team removed the KROX20-producing cells, the mice did not grow any hair, meaning, they became bald. And when they removed the SCF gene, the mices hair started out as gray-colored, then turned white with age.

From these results, the obvious way forward is to backtrack whats happening, possibly try to figure out why and how aging affects KROX20 protein production. Another aspect that will also be looked at is the reason why the SCF gene stops functioning, thereby resulting in gray hair production. The findings could also help provide answers on why hair loss and graying of hair are among the first indications of aging.

The research was recently published in the journal Genes & Development.

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A team of researchers at the Gladstone Institutes uncovered a new strategy to treat heart failure, a leading contributor to mortality and healthcare costs in the United States. Despite widespread use of currently-approved drugs, approximately 40% of patients with heart failure die within 5 years of their initial diagnosis.

"The current standard of care is clearly not sufficient, which highlights the urgent need for new therapeutic approaches," said Saptarsi Haldar, MD, an associate investigator at Gladstone and senior author of a new study featured on the cover of the scientific journal Science Translational Medicine. "In our previous work, we found that a drug-like small molecule called JQ1 can prevent the development of heart failure in mouse models when administered at the very onset of the disease. However, as the majority of patients requiring treatment already have longstanding cardiac dysfunction, we needed to determine if our strategy could also treat established heart failure."

As part of an emerging treatment strategy, drugs derived from JQ1 are currently under study in early-phase human cancer trials. These drugs act by inhibiting a protein called BRD4, a member of a family of proteins called BET bromodomains, which directly influences heart failure. With this study, the scientists found that JQ1 can effectively treat severe, pre-established heart failure in both small animal and human cell models by blocking inflammation and fibrosis (scarring of the heart tissue).

"It has long been known that inflammation and fibrosis are key conspirators in the development of heart failure, but targeting these processes with drugs has remained a significant challenge," added Haldar, who is also a practicing cardiologist and an associate professor in the Department of Medicine at the University of California, San Francisco. "By inhibiting the function of the protein BRD4, an approach that simultaneously blocks both of these processes, we are using a new and different strategy altogether to tackle the problem."

Currently available drugs used for heart failure work at the surface of heart cells. In contrast, Haldar's approach goes to the root of the problem and blocks destructive processes in the cell's command center, or nucleus.

"We treated mouse models of heart failure with JQ1, similarly to how patients would be treated in a clinic," said Qiming Duan, MD, PhD, postdoctoral scholar in Haldar's lab and co-first author of the study. "We showed that this approach effectively treats pre-established heart failure that occurs both after a massive heart attack or in response to persistent high blood pressure (mechanical overload), suggesting it could be used to treat a wide array of patients."

Using Gladstone's unique expertise, the scientists then used induced pluripotent stem cells (iPSCs), generated from adult human skin cells, to create a type of beating heart cell known as cardiomyocytes.

"After testing the drug in mice, we wanted to check whether JQ1 would have the same effect in humans," explained co-first author Sarah McMahon, a UCSF graduate student in Haldar's lab. "We tested the drug on human cardiomyocytes, as they are cells that not only beat, but can also trigger the processes of inflammation and fibrosis, which in turn make heart failure progressively worse. Similar to our animal studies, we found that JQ1 was also effective in human heart cells, reaffirming the clinical relevance of our results."

The study also showed that, in contrast to several cancer drugs that have been documented to cause cardiac toxicity, BRD4 inhibitors may be a class of anti-cancer therapeutics that has protective effects in the human heart.

"Our study demonstrates a new therapeutic approach to successfully target inflammation and fibrosis, representing a major advance in the field," concluded Haldar. "We also believe our current work has important near-term translational impact in human heart failure. Given that drugs derived from JQ1 are already being tested in cancer clinical trials, their safety and efficacy in humans are already being defined. This key information could accelerate the development of a new heart failure drug and make it available to patients more quickly."

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New York Times

Babies From Skin Cells? Prospect Is Unsettling to Some Experts ... New York Times Researchers say that scientists may soon be able to create a baby from human skin cells that have been coaxed to grow into eggs and sperm. and more »

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Posted By: Dave Bernstein May 15, 2017

UPDATE: Commissioner Dennis Bolz talks about how much he missed PUD

Chelan County PUD Commissioner Dennis Bolz was able to attend his first board meeting in person this morning after a lengthy absence while undergoing stem cell transplant therapy.

Commissioner Bolz talked with NewsRadio 560 KPQs Dave Bernstein moments before his first board meeting at 10am Tuesday..

Commissioner Bolz has beenin Seattle since January receiving chemotherapy for myelodysplastic syndrome or MDS. The cancer affects the formation of red blood and white cells in the bone marrow.

Bolz thanked the PUD Board , staff and the community for their support and encouragement during his absence and talked about how much he missed the important work at the PUD and being in the Wenatchee Valley.

Commissioner Bolz was presented with a 10 year service pin hemissed receiving in January whilein Seattle undergoing treatment

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On Tuesday, Carson Tahoe Cancer Center opened a new blood and bone marrow transplant care clinic with support from the Huntsman Cancer Institute (HCI) at the University of Utah. Under the collaboration, a Bone Marrow Transplant (BMT) physician and nurse from HCI will travel to Carson City once a month to treat patients both before and after they receive a transplant.

Blood and marrow transplants are performed in patients with cancers of the blood and lymphatic systems, including leukemia, lymphoma and multiple myeloma. The transplants replace bone marrow that has been damaged or destroyed with a supply of healthy blood stem cells, which in turn travel to the bone marrow and promote growth of new marrow.

Currently, patients in the Northern Nevada area who need a transplant must travel outside the area for treatment. Through this model, patients will still receive their transplant at HCI in Salt Lake City. But they will now be able to receive care at the Carson Tahoe clinic for planning and follow-up appointments, which typically occur every month for a year following transplant.

"This clinic is going to enable patients to receive more of their pre-and post-BMT care closer to home," said Daniel Couriel, MD, Professor of Medicine at the University of Utah and Director of HCI's BMT program. "We hope to maximize the time patients can spend in their own homes with their loved ones as they recover."

The BMT clinic will be open the third Monday of every month. Patients can access the clinic by referral.

"Because of the added bench strength we receive from HCI, we are better equipped to provide outstanding bone marrow transplant care, close to home," said Ed Epperson, CEO of CTH.

CTH formally affiliated with University of Utah Health in 2013 and with Huntsman Cancer Institute in 2015 in an effort to improve accessibility to specialty care for Northern Nevada residents. The relationship between the health care systems provides resources that allow Carson Tahoe Health to meet the ever-changing health care needs of the community.

"Both organizations share a commitment to providing the highest quality cancer care to patients, no matter where they live," said John Sweetenham, MD, Executive Medical Director at Huntsman Cancer Institute and Professor of Medicine at the University of Utah. "BMT treatment is a very unique type of care, and we look forward to working with Carson Tahoe to bring this service to the community."

To find out more about the clinic, residents can call Carson Tahoe Cancer Center at 775-445-7500.

Originally posted here:
Carson Tahoe Health opens blood and bone marrow transplant care clinic - Nevada Appeal

Bone Marrow Stem Cells Comments Off on Carson Tahoe Health opens blood and bone marrow transplant care clinic – Nevada Appeal | May 15th, 2017

May 11, 2017

An analysis of data from the entire development program consisting of three trials assessing the feasibility of using a stem cell therapy (CD34+ cells) to treat patients with the most severe cases of angina, refractory angina (RA), showed a statistically significant improvement in exercise time as well as a reduction in mortality. Results from "CD34+ Stem Cell Therapy Improves Exercise Time and Mortality in Refractory Angina: A Patient Level Meta-Analysis" were presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2017 Scientific Sessions in New Orleans.

One of the warning signs of coronary artery disease is angina, or chest pain, which occurs when the heart muscle does not receive enough blood. Unlike angina pectoris or "stable angina," which can often be treated with medication, RA can be incapacitating, impacting quality of life. In the most severe cases, those with class III or IV angina, treatment options are exhausted, and patients remain severely debilitated. Unfortunately, one of the untoward consequences of the improved survival of patients with chronic ischemic heart disease is more patients with refractory angina.

A meta-analysis of three trials that each showed promising results looked at injecting RA patients with autologous CD34+ cellswhich have been shown to increase blood flowand the therapy's effect on mortality and total exercise time (TET), an important predictor of long-term mortality.

Data from 304 patients was extracted and analyzed from phase 1 (24 patients), ACT-34 and ACT-34 extension studies (168 patients), and RENEW (112 patients), which was prematurely terminated by the sponsor due to financial considerations.

"The goal of this meta-analysis was to combine patient level data from three very similar trials to try understand what it would tell us," said lead investigator Tom Povsic, MD, FSCAI, associate professor at the Duke Clinical Research Institute (DCRI) and an interventional cardiologist at Duke University School of Medicine.

Results showed that patients treated with CD34+ cell therapy (n=187) improved TET by 80.5 12.1, 101.8 13.7, and 90.5 14.7 seconds at three months, six months, and 12 months compared with 28.1 15.7, 48.8 18.2, and 39.5 20.3 seconds for the placebo group (n=89), resulting in treatment effects of 52.5 (p=0.002), 52.9 (p=0.009) and 50.9 (p=0.027) seconds.

The relative risk of angina was 0.90 (p=0.40), 0.81 (p=0.14), and 0.79 (p=0.17) at three months, six months, and 12 months in CD34+ treated patients.

CD34+ treatment decreased mortality by 24 months (2.6 percent vs. 11.8 percent, p=0.003). In addition, major adverse cardiac events were less frequent (29.8 percent for CD34+ patients vs. 40.0 percent for the placebo group, p=0.08).

"Therapies for these patients are direly needed," said Povsic, "and results from our meta-analysis are very compelling. Most importantly, the number of patients in our meta-analysis approximates those who were targetedfor enrollment in RENEW, the prematurely terminated phase III study. These results suggest that had RENEW been completed, a regenerative therapy for these patients might meet criteria for approval. I still think this therapy has a lot of promise."

Timothy Henry, MD, chief of cardiology at Cedars-Sinai Medical Center in Los Angeles, agrees "CD34+ cell therapy appears to be an extremely safe and effective therapy for this growing and challenging patient population with limited options."

Explore further: Stem cell therapy shows potential for difficult-to-treat RA patient population

More information: Povsic presented "CD34+ Stem Cell Therapy Improves Exercise Time and Mortality in Refractory Angina: A Patient Level Meta-Analysis" on Thursday, May 11, 2017 11:30 a.m. CDT

A study using a stem cell therapy to treat challenging refractory angina (RA) patients demonstrated promising results, including improved exercise time, reduced angina and reduced mortality. The RENEW results were presented ...

A two-year, multi-center clinical study with 167 patients with class III-IV refractory angina randomized to low and high dose CD34+ cells or placebo has revealed that patients who received either a high or low dose of CD34a ...

The absolute cumulative probability of death at 12 months was 5 percent lower for patients who received routine invasive coronary angiography and revascularization as indicated during an unstable angina admission compared ...

An injection of stem cells into the heart could offer hope to many of the 850,000 Americans whose chest pain doesn't subside even with medicine, angioplasty or surgery, according to a study in Circulation Research: Journal ...

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A non-surgical treatment that uses a patient's own bone marrow stem cells to treat chest pain or angina improved both symptoms and the length of time treated patients could be physically active, according to preliminary research ...

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Less than half of individuals with peripheral artery disease, which is a narrowing of arteries to the limbs, stomach and head, are treated with appropriate medications and lifestyle counseling. These findings highlight the ...

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