Archive for the ‘Cardiac Stem Cells’ Category
BWH settles research fraud allegations – Mission Hill Gazette
Brigham and Womens Hospital (BWH) will pay $10 million to resolve allegations that one of their stem cell research laboratories fraudulently obtained grant funding from the National Institutes of Health (NIH), according to a press release.
As per federal regulations and institutional policy requirements, BWH conducted an investigation that identified data integrity concerns in federally funded grant applications submitted by the Anversa lab. After learning of and investigating the allegations of misconduct in the Anversa laboratory, BWH disclosed its concerns to the U.S. Department of Health and Human Services, Office of the Inspector General, and Office of Research Integrity.
BWH independently evaluated the issues relative to the federal false claims requirements, said Lori Schroth, media relations manager at BWH. Following that evaluation, BWH self-disclosed this matter to appropriate government entities and ceased drawing implicated funds.
The settlement resolves the allegations against Dr. Piero Anversa, who ran the laboratory, and Drs. Annarossa Leri and Jan Kajstura. Allegedly, the doctors knew or should have known that their laboratory published and relied upon manipulated and falsified information including microscope images and carbon-14 age data for cells, according to the press release. This information was used in applications for NIH research grant awards concerning the purported ability of stem cells to repair damage to the heart.
The settlement also resolves allegations that the laboratory followed improper protocols, inaccurately characterized cardiac stem cells, and kept recklessly or deliberately misleading records, according to the press release.
Drs. Anversa, Leri, and Kajstura are no longer affiliated with BWH, and the lab has since been closed.
BWH is committed to ensuring that research conducted at the institution is done under the most rigorous scientific standards, and has made significant enhancements to research integrity compliance protocols as a result of this event, said Schroth.
Acting U.S. Attorney William D. Weinreb said in the press release that individuals and institutions that receive research funding from NIH have an obligation to conduct their research honestly and not to alter results to conform with unproven hypotheses.
Medical research fraud not only wastes scarce government resources but also undermines the scientific process and the search for better treatments for serious diseases, Weinreb said, according to the press release. We commend Brigham and Womens for self-disclosing the allegations of fraudulent research at the Anversa laboratory, and for taking steps to prevent future recurrences of such conduct.
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BWH settles research fraud allegations - Mission Hill Gazette
stem cells – Shirley’s Wellness Cafe
Aqua Botanical Stem Cell Therapy
Ethical concerns have slowed embryonic medical research into applications for stem cells. Also, the embryonic stem cells can unpredictably cause cancer in the treated patient.
New research demonstrate that Stem cell nutrition dereived from aqua botanical source supports the natural role of adult stem cells. These plant stem cell extracts are typically derived from certain edible algae that grows in fresh water.
When there is an injury or a stress to an organ, compounds are released that reach the bone marrow and trigger the release of stem cells. Stem Cells can be thought of as master cells. Stem cells circulate and function to replace dysfunctional cells, thus fulfilling the natural process of maintaining optimal health
Dr. Robert Sampson, MD on stem cell nutrition - "... we have a product that has been shown and demonstrated in the patent to increase the level of adult circulating stem cells by up to 30%. It seems to me we're having a great opportunity here to optimize the body's natural ability to create health."
Stem cell nutrition are typically aquatic botanicals and support wellness by assisting the body in its ability to maintain healthy stem cell physiology, production, and placement. Just as antioxidants are important to protect your cells from free radical damage, stem cell nutrition is equally important to support your stem cells in maintaining proper organ and tissue functioning in your body.
The health benefits of having more stem cells in the blood circulation have been demonstrated by numerous scientific studies. It would be too long here to summarize this vast body of scientific data. I simply suggest you research the work of Dr. Donald Orlic at the National Institute of Health.
The theory that Adult Stem Cells are nothing less than the human body's natural self-renewal system has profound implications for every area of modern medicine. The idea that heart disease, diabetes, liver degeneration, and other conditions could be things of the past is no longer science fiction; because of recent Adult Stem Cell research breakthroughs, these are real possibilities in the short term.
Stem cells are defined as cells with the unique capacity to self-replicate throughout the entire life of an organism and to differentiate into cells of various tissues. Most cells of the body are specialized and play a well-defined role in the body. For example, brain cells respond to electrical signals from other brain cells and release neurotransmitters; cells of the retina are activated by light, and pancreatic -cells produce insulin. These cells, called somatic cells, will never differentiate into other types of cells or even proliferate. By contrast, stem cells are primitive cells that remain undifferentiated until they receive a signal prompting them to become various types of specialized cells.
Dr. Cliff Minter - "Stem cells are the most powerful cells in the body. We know that stem cells, once they're circulating in the bloodstream, will travel to any area of the body that has been compromised or damaged and turn into healthy cells. There have been controversial discussions about the new stem cells found in embryos, but the truth is that everyone has adult stem cells in their own bodies. We are all created from stem cells.
As a child or a young adult, your body automatically releases stem cells whenever you injure yourself. That's why you heal so fast when you are younger. After about age 35, we don't heal as fast anymore, because the stem cells aren't released the same way as when we are younger. Stem cell nutrition helps all of us heal our bodies. If you look at the New England Journal of Medicine, you'll find that the number one indicator of a healthy heart is the number of stem cells circulating in the body. Stem cell nutrition is the organic and all-natural way to stimulate the bone marrow to release adult stem cells into the bloodstream.
By taking stem cell nutrition, you can maintain optimum health and aid your body in healing itself. It's certainly a better way to recuperate from an illness than using prescription drugs, because even when a medication works, it can often be hard on your liver and the rest of your body. Stem cell nutrition has no negative side effects. This makes it a powerful approach to healing and good health in general.
I found out about stem cell nutrition after someone asked for my opinion on it. I did some research and found it to be one of the greatest ways to slow down aging that we have. Aging is nothing more than the breakdown of cells. Stem cell nutrition combats that action. As cells break down, stem cell nutrition replaces them with healthy cells. This is the greatest, most natural anti-aging method I know. I was skeptical at first, but the results I've personally seen in people I've talked with have been wide-ranged. Lots of people have reported an increase in energy and better sleeping patterns.
I've seen people with arthritis in various parts of their bodies reverse the disease, and people with asthma end up with their lungs totally clear. One person that was on oxygen almost 24/7 is now totally off of oxygen. Two ladies who suffered badly from PMS told me they were 100 percent symptom-free within weeks of starting the stem cell nutrition. Two people I know had tennis elbow which usually takes about six to nine months to heal. Within weeks of taking stem cell nutrition, both report their "tennis elbow" is gone. It makes sense, because stem cells go to whatever area is compromised and turn into healthy cells.
I use stem cell nutrition as a preventative. I've noticed an increase in my energy level and an improved sleeping pattern. Stem cell nutrition has zero negative side effects, is very powerful, and we know how it works. It's good for children as well as adults. This is the best, most natural way I know to optimum health. If you just want to use it for prevention, this is the best thing I know for staying healthy. And if you do those and regaining optimum health. I recommend it to everybody."
Dr. Cliff Minter (retired) graduated from Illinois College of Podiatric Medicine. He completed his residency at the Hugar Surgery Center in the Hines Veteran Administration Hospital in Illinois before going into private practice in Ventura, CA. Dr. Minter is a national and international speaker on the subjects of business and nutritional products.
The Stem Cell Theory of Renewal proposes that stem cells are naturally released by the bone marrow and travel via the bloodstream toward tissues to promote the body's natural process of renewal. When an organ is subjected to a process that requires renewal, such as the natural aging process, this organ releases compounds that trigger the release of stem cells from the bone marrow. The organ also releases compounds that attracts stem cells to this organ. The released stem cells then follow the concentration gradient of these compounds and leave the blood circulation to migrate to the organ where they proliferate and differentiate into cells of this organ, supporting the natural process of renewal.
Most of the cells in the human body are specialists assigned to a specific organ or type of tissue, such as the neuronal cells that wire the brain and central nervous system. Stem cells are different. When they divide, they can produce either more stem cells, or they can serve as progenitors that differentiate into specialized cells as they mature. Hence the name, because specialist cells can "stem" from them. The potential to differentiate into specialist cells whose populations in the body have become critically depleted as the result of illness or injury is what makes stem cells so potentially valuable to medical research.
The idea is that if the fate of a batch of stem cells could be directed down specific pathways, they could be grown, harvested, and then transplanted into a problem area. If all went according to plan, these new cells would overcome damaged or diseased cells, leading to healing and recovery. "The life of a stem cell can be viewed as a hierarchical branching process, where the cell is faced with a series of fate switches," Schaffer says. "Our goal is to identify the cell fate switches, and then provide stem cells with the proper signals to guide them down a particular developmental trajectory."
Stem cells have the remarkable potential to develop into many different cell types in the body. Serving as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.
When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function. Scientists believe it should be possible to harness this ability to turn stem cells into a super "repair kit" for the body.
Scientist and author Christian Drapeau explains how the Stem Cell enhancers function to maximize human performance - Supporting the release of stem cells from the bone marrow and increasing the number of circulating stem cells improves various aspects of human health. For very active and sports focused people, Stem Cells are the raw materials to repair micro-tears and micro-injuries created during training. The results, according to Drapeau, are that active people, whether former NBA stars or amateur weekenders, can exercise more intensely at each training session with the ultimate consequence of greater performance.
Theoretically, it should be possible to use stem cells to generate healthy tissue to replace that either damaged by trauma, or compromised by disease. Among the conditions which scientists believe may eventually be treated by stem cell therapy are Parkinson's disease, Alzheimer's disease, heart disease, stroke, arthritis, diabetes, burns and spinal cord damage.
Both of my big dogs have gained their youth back. I am a true believer in Stem Cell Nutrition for pets as it has provided a spectacular change in both Ginger and Rowdy. Sonya, IN
Stem cell nutrition for dogs, horses and other animals are specially formulated to be a delectable treat for your animal. The pet chewables and equine blends make it easy to provide your animals with this valuable nutritional supplement. The most common story is that of old, tired and sluggish dogs turned within a week or so into active, alert dogs running around like puppies. The same was observed in horses. Old horses who used to remain standing in the barn or under a tree, sluggish or stricken by too much discomfort to walk around, suddenly began moving about, and at times running and bucking like young colts. One of the most common reports was obvious improvements in hoof health and coat appearance.
times. When there is an injury or a stress to an organ of your beloved pet or horse, compounds are released that reach the bone marrow and trigger the release of stem cells. Stem Cells can be thought of as master cells. Stem cells circulate and function to replace dysfunctional cells, thus fulfilling the natural process of maintaining optimal health.
As they do in humans, adult stem cells reside in animals bone marrow, where they are released whenever there is a problem somewhere in the body. Looking back on stem cell research, we realize that most studies have been done with animals, mostly mice, but also with dogs, horses, pigs, sheep and cattle. These studies have revealed that animal stem cells conduct themselves the same way human stem cells do. When there is an injury or a stress to an organ of your beloved pet or horse, compounds are released that reach the bone marrow and trigger the release of stem cells. The stem cells then travel to tissues and organs in need of help to regain optimal health.
Eve-Marie Lucerne - Eve-Marie keeps nine horses, all older thoroughbreds, and was eager to participate in the trials of a new stem cell enhancer for horses. She shared her allotment of test products with a few large commercial thoroughbred farms, veterinarians and other horse people she knows, and has been pleased with the consistently excellent results she has seen and others have reported to her. This product will help so many animals, she says, adding, People and animals are more alike than we are different. So it makes sense that a stem cell enhancer for animals with promote their health, too.
Eve-Marie's Equine Stem Cells Nutrition show dramatic results. For several horses facing serious physical challenges, cases where the animals might have to be put down, we saw a return to quality of life. This did not happen before Equine Stem Cell Nutrition. Eve-Marie says that this turnaround was quick, less than two weeks in many cases, and that the subject horses were back to health and enjoying pasture life within a month. One of the unofficial trial subjects for the equine stem cell nutrition was a 30-year old donkey who was in bad shape, Eve-Marie reports. He hadchronic respiratory difficulty and could move about only haltingly. His owner had stem cell enhancer supplements to help with her own serious health challenges and shared it with the donkey. The donkey's owner says this is the first time she wasn't sick, and her donkey is walking all around, feeling great an enjoying life again!
Farrier and National Hoof practitioner Stephen Dick received some of the trial product from Eve-Marie, and had good results with the two horses he selected for trial. For a 12-year-old quarterhorse stallion, the equine product brought dramatic results. This horse used to lie down twenty-two hours of the day, because he suffered discomfort whenever he stood, Steve reports, continuing, after a couple of weeks with Equine Stem Cell Nutrition, he was getting up and moving around, showing no discomfort. For a high-spirited mare with a leg problem, the equine product brought about a whole new lease on life, Steve says. This horse had been in a stall for 8 months. After about 6 weeks taking the equine product with her grain, her condition had improved and she was out of the stall, walking around in the pasture again.
Little Joe, a small 18-year-old quarter horse that Judy Fisher bought when he was nearly 400 pounds underweight. You could count his ribs, Judy says, remembering, and his backbone stuck up like a ridge all along his back. He was very, very thin! Little Joe also suffered from breathing problems that kept him lethargic and inactive. Vet-recommended remedies were unsuccessful in changing Little Joe's physical problems, and the vet told Judy he didn't expect Little Joe to live through the winter. I figured Little Joe was in such bad shape that anything was worth a try, she says.
She began giving the horse stem cell nutrition with his feed and grain twice a day. Within a couple of weeks, Judy was surprised to see Little Joe beginning to gain weight and run, buck, snort and kick. His breathing was no longer labored and his skin and coat were improving. Within six weeks Little Joe's overall appearance had changed dramatically. He had put on almost 300 pounds. When his former owner came to visit, Judy says, he didn't recognize Little Joe. That's how different he looked!
Sara participated in the stem cell nutrition product trials with her two horses and her 80-pound mixed-breed dog. She noted significant improvement in the health and quality of life for all three animals during the time of the trials. For JJ, Sara's 18-year old quarterhorse, the equine product brought about improvements in his overall mood, appearance and alertness quickly. He really liked the product from the beginning, Sara reports, pointing out that Hank, her 16-year-old thoroughbred/quarterhorse, had not taken to the taste of it too readily. I was able to slowly wean him on it though, she says. For Hank, the equine product was a balm for the skin problems resulting from his allergy to fly bites.
His skin condition improved dramatically. Sara reports, noting that before the equine product the horse had scratched and bitten himself into ope wounds; after the equine product, the scratching and biting dropped off to almost nothing. Sara also noticed an increase in Hank's energy and liveliness in the first week on the equine product. The horse's foot and hip discomforts also responded well, leading to a noticeable increase in his mobility and an overall improvement in his quality of life throughout the two-month study.
Sara gave the pet product to her dog, Roxy, who had suffered for two years with ear problems that led to scratching, often until her skin was raw. Vet-recommended remedies had been temporary, quick-fixes, Sara says, but the discomfort always returned with a vengeance. For the pet trials, Sara gave Roxy two tabs of the product a day for two months, noting this is the only supplement she was getting. Sara says Roxy's problem with her ears definitely improved, the hair as grown back on her head and ears, and the ear problem has not recurred, adding that Roxy is happier and engaging, more playful.
The National Health Institute lists seventy-four treatable diseases using ASCs in therapy - an invasive and costly procedure of removing the stem cells from one's bone marrow (or a donor's bone marrow) and re-injecting these same cells into an area undergoing treatment. For example, this procedure is sometimes done before a cancer patient undergoes radiation. Healthy stem cells from the bone marrow are removed and stored, only to be re-inserted after radiation into the area of the body in need of repair. This is a complex and expensive procedure, not accessible to the average person. However, there is now a way that every single person, no matter what their health condition, can have access to the benefits of naturally supporting their body's innate ability to repair every organ and tissue using stem cell nutrition.
David A. Prentice, Ph.D. - "Within just a few years, the possibility that the human body contains cells that can repair and regenerate damaged and diseased tissue has gone from an unlikely proposition to a virtual certainty. Adult stem cells have been isolated from numerous adult tissues, umbilical cord, and other non-embryonic sources, and have demonstrated a surprising ability for transformation into other tissue and cell types and for repair of damaged tissues.
A new U.S. study involving mice suggests the brain's own stem cells may have the ability to restore memory after an injury. These neural stem cells work by protecting existing cells and promoting neuronal connections. In their experiments, a team at the University of California, Irvine,were able to bring the rodents' memory back to healthy levels up to three months after treatment. The finding could open new doors for treatment of brain injury, stroke and dementia, experts say.
"This is one of the first reports that you can take a stem cell transplantation approach and restore memory," said lead researcher Mathew Blurton-Jones, a postdoctorate fellow at the university. "There is a lot of awareness that stem cells might be useful in treating diseases that cause loss of motor function, but this study shows that they might benefit memory in stroke or traumatic brain injury, and potentially Alzheimer's disease."
In the study, published in the Oct. 31 issue of the Journal of Neuroscience, Blurton-Jones and his colleagues used genetically engineered mice that naturally develop brain lesions. The researchers destroyed cells in a brain area called the hippocampus. These cells are known to be vital to memory formation and it is in this region that neurons often die after injury, the researchers explained. To test the mice's memory, Blurton-Jones's group conducted place and object recognition tests with both healthy mice and brain-injured mice.
Healthy mice remembered their surroundings about 70 percent of the time, while brain-injured mice remembered it only 40 percent of the time. For objects, healthy mice recalled objects about 80 percent of the time, but injured mice remembered them only 65 percent of the time. The researchers then injected each mouse with about 200,000 neural stem cells. They found that mice with brain injuries that received the stem cells now remembered their surroundings about 70 percent of the time -- the same as healthy mice. However, mice that didn't receive stem cells still had memory deficits.
The researchers also found that in healthy mice injected with stem cells, the stem cells traveled throughout the brain. In contrast, stem cells given to injured mice lingered in the hippocampus. Only about 4 percent of those stem cells became neurons, indicating that the stem cells were repairing existing cells to improve memory, rather than replacing the dead brain cells, Blurton-Jones's team noted. The researchers are presently doing another study with mice stricken with Alzheimer's. "The initial results are promising," Blurton-Jones said. "This has a huge potential, but we have to be cautious about not rushing into the clinic too early."
One expert is optimistic about the findings. "Putting in these stem cells could eventually help in age-related memory decline," said Dr. Paul R. Sanberg, director of the Center of Excellence for Aging and Brain Repair at the University of South Florida College of Medicine. "There is clearly a therapeutic potential to this." Sanberg noted that for the process to work with Alzheimer's it has to work with older brains. "There is clearly therapeutic potential in humans, but there are a lot of hurdles to overcome," he said. "This is another demonstration of the potential for neural stem cells in brain disorders.".
Dr. Nancy White Ph.D.- " I've always been interested in health generally and in particular the brain, focusing on the balance of neurotransmitters. I often do quantitative EEG's for assessment of my patients. I'm impressed with the concept of a natural product like stem cell nutrition that could help release adult stem cells from the bone mass where the body would have no objection and no rejection. I've tried stem cell nutrition for general health anti-aging. After taking it for a time, I fell more agile and my joints are far more flexible. I was astounded while doing yoga that I was suddenly able to bend over and touch my forehead to my knees. I haven't been able to do that comfortably in probably twenty years. I noticed how much better my balance has become. I believe stem cell nutrition is responsible for these effects, because I certainly haven't been trained extensively in yoga. Also since taking stem cell nutrition, I feel better and my skin is more moist and has a finer texture.
A bald friend of mine, who is also taking the stem cell nutrition, had several small cancers on top of his head. His doctor had removed one from his arm already, and his dermatologist set a date to remove those from his scalp. Before the appointment, my friend was shaving one morning and, looking in the mirror, saw that the cancers were all gone. They had disappeared within a few weeks of starting the stem cell nutrition and his skin is better overall. Also, his knee, which he'd strained playing tennis, was like new. Stem cell nutrition seems to go where the body's priority is. You never know what the affect is going to be, but you notice something is changing. Another friend of mine seems to be dropping years. Her skin looks smoother and her face younger. After about six weeks on the stem cell nutrition, she looks like she's ten years younger. A woman who gives her regular facials asked what she was doing, because her skin looked so much different. Stem cell nutrition is remarkable and could help anybody. Everybody should try it, because it's natural and there are no risks. As we grow older in years, we still can have good health. That's the ideal. Even if you don't currently have a problem, stem cell nutrition is a preventative." Dr. White holds a Ph. D. in Clinical Psychology, an MA in Behavioral Science, and a B.F.A. in Fine Arts, Magna Cum Laude. In addition, she is licensed in the State of Texas as a Psychologist , a Marriage and Family Therapist and as a Chemical Dependency Counselor.
Fernando Aguila, M.D. - "Due to a heavy patient load, I have recently found that I tire more easily, my legs are cramping, and by the time I get home, even my shoulders and rib cage hurt. I knew I had to find a way to increase my stamina, energy and vitality. A friend gave me information about stem cell nutrition and how it promotes the release of stem cells in the body. One of the components apparently promotes the migration of the stem cells to tissues or organs where regeneration and repair is needed most. My attention was drawn to the fact that it can increase energy, vitality, wellness, concentration, and much more. It sounded just like what I needed. Since then, I've heard reports of people experiencing excellent results in a number of different areas in their health. The improvements sounded dramatic. Because of all of their testimonies, I was willing to believe it could promote wellness in the human body.
I tried stem cell nutrition myself. After a day, of hard work, I realized I wasn't tired at all, my legs were not aching, and I didn't have any shoulder pain. I decided the stem cell nutrition must be working. I continued to take it, and was able to work so efficiently and steadily that one surgeon commented that I was moving like a ball of fire. Stem cell nutrition gives me support physically and mentally. I look forward to seeing what the major medical journals have to say about the studies being done with this new approach to wellness." Fernando Aguila, M.D., graduated from the University of Santa Thomas in Manila , Philippines. He finished his internship at Cambridge City Hospital, Cambridge, MA and completed his residency at the New England Medical Center in Boston, MA. He obtained a fellowship in OB-GYN anesthesia at the Brigham and Women's Hospital in Boston and a fellowship in cardio-thoracic anesthesia at the Cleveland Clinic Foundation in Cleveland, OH.
Christian Drapeau is America's best known advocate for Adult Stem Cell science health applications and the founder of the field of Stem Cell Nutrition. He holds a BS in Neurophysiology from McGill University and a Master of Science in Neurology and Neurosurgery from the Montreal Neurological Institute.
One particular stem cell enhancers that was studied was found to contain a polysaccharide fraction that was shown to stimulate the migration of Natural Killer (NK) cells out of the blood into tissues. The same polysaccharide fraction was also shown to strongly stimulate the activation of NK cells. NK cells play the very important role in the body of identifying aberrant or defective cells and eliminating them. NK cells are especially known for their ability to detect and destroy virally infected cells and cells undergoing uncontrolled cellular division. The same polysaccharide fraction was also shown to stimulate macrophage activity. Macrophages constitute the front line of the immune system. They first detect an infection or the presence of bacteria or virally infected cells, and they then call for a full immune response. Adult Stem Cell Nutritional Enhancer also contains a significant concentration of chlorophyll and phycocyanin, the blue pigment in AFA. Phycocyanin has strong anti-inflammatory properties and therefore can assist the immune system.
The release of stem cells from the bone marrow and their migration to tissues is a natural process that happens everyday. Stem cell enhancers simply support that natural process and tips the balance toward health everyday. It does not do anything that the body does not already do everyday. So far, no instances of cancer or any similar problem have ever been observed when using in vivo natural release of stem cells from the bone marrow.
Each day, stem cells in the bone marrow evolve to produce red blood cells, white blood cells, and platelets. These mature cells are then released into the bloodstream where they perform their vital life-supporting functions. When bone marrow stem cell activity is interfered with, diseases such as anemia (red blood cell deficit), neutropenia (specialized white blood cell deficit), or thrombocytopenia (platelet deficit) are often diagnosed. Any one of these conditions can cause death if not corrected.
Scientists have long known that folic acid, vitamin B12, and iron are required for bone marrow stem cells to differentiate into mature red blood cells.3-7 Vitamin D has been shown to be crucial in the formation of immune cells,8-11 whereas carnosine has demonstrated a remarkable ability to rejuvenate cells approaching senescence and extend cellular life span.12-28
Other studies of foods such as blueberries show this fruit can prevent and even reverse cell functions that decline as a result of normal aging.29-36 Blueberry extract has been shown to increase neurogenesis in the aged rat brain.37,38 Green tea compounds have been shown to inhibit the growth of tumor cells, while possibly providing protection against normal cellular aging.39,40
Based on these findings, scientists are now speculating that certain nutrients could play important roles in maintaining the healthy renewal of replacement stem cells in the brain, blood, and other tissues. It may be possible, according to these scientists, to use certain nutrient combinations in the treatment of conditions that warrant stem cell replacement
These studies demonstrate for the first time that various natural compounds can promote the proliferation of human bone marrow cells and human stem cells. While these studies were done in vitro, they provide evidence that readily available nutrients may confer a protective effect against today's epidemic of age-related bone marrow degeneration.
Dr. Robert Sampson, MD on stem cell nutrition - "... we have a product that has been shown and demonstrated in the patent to increase the level of adult circulating stem cells by up to 30%. It seems to me we're having a great opportunity here to optimize the body's natural ability to create health." Recent scientific developments have revealed that stem cells derived from the bone marrow, travel throughout the body, and act to support optimal organ and tissue function. Stem cell enhancers supports the natural role of adult stem cells. Stem cell enhancer are typically derived from certain edible algae that grows in fresh water.
The possibility that a decline in the numbers or plasticity of stem cell populations contributes to aging and age-related disease is suggested by recent findings. The remarkable plasticity of stem cells suggests that endogenous or transplanted stem cells can be tweaked' in ways that will allow them to replace lost or dysfunctional cell populations in diseases ranging from neurodegenerative and hematopoietic disorders to diabetes and cardiovascular disease.
As you age, the number and quality of stem cells that circulate in your body gradually decrease, leaving your body more susceptible to injury and other age-related health challenges. Just as antioxidants are important to protect your cells from free radical damage, stem cell nutrition is equally important to support your stem cells in maintaining proper organ and tissue functioning in your body.
A fundamental breakthrough in our understanding of nervous system development was the identification of multipotent neural stem cells (neurospheres) about ten years ago. Dr. Weiss and colleagues showed that EGF (epidermal growth factor) dependent stem cells could be harvested from different brain regions at different developmental stages and that these could be maintained over multiple passages in vitro. This initial finding has lead to an explosion of research on stem cells, their role in normal development and their potential therapeutic uses. Many investigators have entered this field and the progress made has been astounding.
How does an increase in the number of circulating stem cells lead to optimal health? Circulating stem cells can reach various organs and become cells of that organ, helping such organ regain and maintain optimal health. Recent studies have suggested that the number of circulating stem cells is a key factor; the higher the number of circulating stem cells the greater is the ability of the body at healing itself. Scientific interest in adult stem cells has centered on their ability to divide or self-renew indefinitely, and generate all the cell types of the organ from which they originate, potentially regenerating the entire organ from a few cells. Adult stem cells are already being used clinically to treat many diseases. These include as reparative treatments with various cancers, autoimmune disease such as multiple sclerosis, lupus and arthritis, anemias including sickle cells anemia and immunodeficiencies. Adult stem cells are also being used to treat patients by formation of cartilage, growing new corneas to restore sight to blind patients, treatments for stroke, and several groups are using adult stem cells to repair damage after heart attacks. Early clinical trials have shown initial success in patient treatments for Parkinsons disease and spinal cord injury. The first FDA approved trial to treat juvenile diabetes in human patients is ready to begin at Harvard Medical School, using adult stem cells. An advantage of using adult stem cells is that in most cases, the patients own stem cells can be used for the treatment, circumventing the problems of immune rejection, and without tumor formation.
Why do we hear much in the news about embryonic stem cells and very little about adult stem cells? The first human embryonic stem cells were grown in vitro, in a petri dish, in the mid 1990s. Rapidly, scientists were successful at growing them for many generations and to trigger their differentiation into virtually any kind of cells, i.e. brain cells, heart cells, liver cells, bone cells, pancreatic cells, etc. When scientists tried growing adult stem cells, the endeavor was met with less success, as adult stem cells were difficult to grow in vitro for more than a few generations. This led to the idea that embryonic stem cells have more potential than adult stem cells. In addition, the ethical concerns linked to the use of embryonic stem cells have led to a disproportionate representation of embryonic stem cells in the media. But recent developments over the past 2-3 years have established that adult stem cells have capabilities comparable to embryonic stem cells in the human body, not in the test tube. Many studies have indicated that simply releasing stem cells from the bone marrow can help support the body's natural process for renewal of tissues and organs.
The bone marrow constantly produces stem cells for the entire life of an individual. Stem cells released by the bone marrow are responsible for the constant renewal of red blood cells and lymphocytes (immune cells). A 25-30% increase in the number of circulating stem cells is well within physiological range and does not constitute stress on the bone marrow environment. The amount of active bone marrow amounts to about 2,600 g (5.7 lbs), with about 1.5 trillion marrow cells. Stem cells that do not reach any tissue or become blood cells return to the bone marrow.
Effectiveness of stem cell "enhancers" was demonstrated in a triple-blind study. Volunteers rested for one hour before establishing baseline levels. After the first blood samples, volunteers were given stem cell "enhancers"or placebo. Thereafter, blood samples were taken at 30, 60 and 120 minutes after taking the consumables. The number of circulating stem cells was quantified by analyzing the blood samples using Fluorescence-Activated Cell Sorting (FACS). Consumption of stem cell "enhancers" triggered a significant 25-30% increase in the number of circulating stem cells.
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stem cells - Shirley's Wellness Cafe
Arctic drilling, controversial reforms and new views of Saturn – Nature.com
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Cassini catches new views of Saturn NASAs Cassini spacecraft plunged between Saturn and its rings on 26 April, beginning the final stages of its 20-year mission. At its closest, Cassini whizzed just 300 kilometres from the innermost visible edge of Saturns rings and 3,000kilometres above the top of the planets clouds. The images sent back include this close-up shot of Saturns surface. The spacecraft is exploring this never-before-visited region of the Solar System on its way to a final plunge into Saturns atmosphere in September.
NASA/JPL-Caltech/Space Science Inst.
Physics for all Particle physicists will soon be able to publish open-access papers in three journals of the American Physical Society (APS), including Physical Review Letters, free of charge. The deal, announced on 27April, was struck between the APS and CERN, the European particle-physics laboratory in Switzerland. From January 2018, high-energy physics research done anywhere in the world will be able to be published open-access in the journals, and at no direct cost. Publication fees will be covered by the Sponsoring Consortium for Open Access Publishing in Particle Physics (SCOAP3), an international partnership set up in 2012 that is funded in large part by libraries. CERNs Large Hadron Collider already had an open-access agreement with the APS.
Cash boost BioRxiv, a free online archive for draft versions of biology research papers, is to receive a windfall from the philanthropic Chan Zuckerberg Initiative (CZI), founded by Facebook co-founder Mark Zuckerberg and his physician wife Priscilla Chan. On 26April, the initiative announced a multi-year funding package the terms of which have not been disclosed for expanding the popular preprint server, which posted its 10,000th manuscript last month. The new money will pay for staff and technology development at bioRxiv, says John Inglis, the executive director of Cold Spring Harbor Laboratory Press and co-founder of the 3-year-old site.
Poor protection A cross-party group of UK politicians has rebuked the countrys government over its ocean-protection record. In a report released on 25April, the Environmental Audit Committee says marine protected areas around the coasts of the British Isles are not managed properly and that vulnerable sites and species are not suitably protected. The committee says it is also shocked and disappointed that the government will not be creating reference sites to help gauge the success of the network of protected areas. Only 50marine conservation zones have been created in British waters, whereas 127 were recommended in 2011.
Legal concerns Hungarys revised higher-education law is incompatible with internal market freedoms and the right of academic freedom in the European Union (EU), the European Commission said on 26 April. The contentious law, which was passed by the Hungarian parliament on 4 April, bars international universities from operating in Hungary unless they have a campus in their home country. The commission sent Budapest a letter of formal notice, outlining legal concerns, to which the Hungarian government has one month to respond. Speaking in the European Parliament on 26 April, Hungarys Prime Minister Viktor Orbn rejected accusations that the law would specifically target the Central European University in Budapest.
Eric Vidal/Reuters
Hungarys Prime Minister Viktor Orbn.
UK research reform On 27April, the British parliament approved a controversial package of reforms to the organization of UK research and universities. Nine research-funding agencies, including Britains seven research councils, will now be merged into a new body, called UK Research and Innovation. The organization will oversee annual spending of more than 6billion (US$7.8 billion). Parliaments unelected upper chamber, the House of Lords, had forced the government into a number of compromises in the reform, including safeguards for institutional autonomy and the independence of research funding from political interference.
Stem-cell payout Allegations of fraud at a US stem-cell laboratory have led to an order for Partners HealthCare System and Brigham and Womens Hospital (BWH) of Boston, Massachusetts, to pay US$10million to the government. The settlement, announced by the US Department of Justice on 27April, came in response to charges that the laboratory of former BWH researcher Piero Anversa used manipulated and falsified data about his research involving cardiac stem cells in applications for federal research funds. Anversa and a colleague sued the hospital in 2014, charging that its investigation of the allegations had damaged their careers. That lawsuit was dismissed.
Offshore drilling President Donald Trump has asked the US Department of the Interior to reopen Arctic federal waters for oil and gas drilling. On 28April, Trump signed an executive order to lift restrictions on offshore mineral exploration in the Beaufort and Chukchi seas. The controls had been imposed by Barack Obamas administration in response to environmental concerns. The order also asks for a review of the five-year plan to sell oil and gas leases in parts of the Gulf of Mexico and Atlantic Ocean areas that the previous administration had closed to offshore exploration and development.
Fishy results Swedens Central Ethical Review Board has ruled that two researchers at Uppsala University have been guilty of scientific dishonesty in relation to a study published last year in Science (O. M. Lnnstedt and P. Eklv Science 352, 12131216; 2016). The board says that the paper by Oona Lnnstedt and Peter Eklv on the claimed harmful impact of microplastics on certain fish larvae should be withdrawn. Uppsala University says it will consider this report alongside an earlier report conducted by the university itself, which found no misconduct.
Leadership row Cell biologist Mary Beckerle has been invited to return to her position as head of the Huntsman Cancer Institute, housed at the University of Utah in Salt Lake City but mainly funded by billionaire Jon Huntsman. Last month, Vivian Lee, dean of the universitys school of medicine and senior vice-president for health sciences, fired Beckerle for undisclosed reasons. In response, institute staff raised protests and Huntsman threatened to revoke a planned donation. Following Beckerles reinstatement on 25 April, Huntsman released a statement pledging US$120million to the institute. On 28 April, Vivian Lee resigned from her leadership positions.
Preventive arrest Stem-cell maverick Davide Vannoni was arrested in Turin, Italy, on 26April after police phone taps indicated that he was seeking new foreign locations to continue his outlawed therapy, according to news reports. Vannoni had been sentenced to jail for conspiracy and fraud for administering unproven stem-cell therapy in Italy to people with incurable diseases through his Stamina Foundation. The sentence was suspended in March last year in a plea bargainon the condition that he cease offering the treatment. Vannoni continued treating people in the Republic of Georgia until the government there banned him in December.
Physicist fired Physicist Etienne Klein has been sacked as president of the Institute for Advanced Studies for Science and Technology (IHEST) in Paris following a series of allegations of plagiarism in his articles and books for the general public. Kleins dismissal was announced in the French governments official journal on 28April. He is replaced by Antoine Petit, head of INRIA, Frances national computer-science agency.
The Arctic is warming more than twice as fast as the rest of the planet. A report by the Arctic Monitoring and Assessment Programme finds that the region was warmer between 2011 and 2014 than at any time since records began around 1900. The rapid warming is hastening the melting of glaciers and sea ice, and boosting sea-level rise. The extent of snow cover across the Arctic regions of North America and Eurasia each June has halved compared with observations before 2000, the report finds.
Source: Snow, Water, Ice, and Permafrost in the Arctic
818 May Details of the Paris climate agreement are negotiated at a United Nations climate-change conference in Bonn, Germany.
89 May Scientists discuss trends in genome editing at a CRISPR congress in London.
913 May The annual Biology of Genomes meeting takes place in Cold Spring Harbor, New York.
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Arctic drilling, controversial reforms and new views of Saturn - Nature.com
US Stem Cell Inc (OTCMKTS:USRM) Receives Institutional Fund … – StockNewsUnion
StockNewsUnion | US Stem Cell Inc (OTCMKTS:USRM) Receives Institutional Fund ... StockNewsUnion US Stem Cell Inc (OTCMKTS:USRM) is a biotechnology company that was formerly known as Bioheart, Inc. US Stem Cell, headquartered in Sunrise, FL, seeks ... |
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US Stem Cell Inc (OTCMKTS:USRM) Receives Institutional Fund ... - StockNewsUnion
VistaGen Therapeutics’ Largest Stockholder Signs 6-Month Lock-Up Agreement – Yahoo Finance
VistaGen Therapeutics' Largest Stockholder Signs 6-Month Lock-Up Agreement Yahoo Finance 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 ... |
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VistaGen Therapeutics' Largest Stockholder Signs 6-Month Lock-Up Agreement - Yahoo Finance
VistaGen Therapeutics’ Largest Stockholder Signs 6-Month Lock-Up Agreement – Marketwired (press release)
SOUTH SAN FRANCISCO, CA--(Marketwired - May 01, 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 that its largest institutional stockholder, holding both common stock and substantially all (99.3%) of the Company's outstanding preferred stock, entered into a 6-month lock-up agreement. Under the agreement, the stockholder and its affiliates agreed to not enter into any transaction involving the Company's securities during the term of the agreement, which runs through late-October 2017 and covers approximately 36% of the Company's issued and outstanding equity securities on an as converted basis.
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 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, and symptoms of Parkinson's disease and Huntington's disease, where modulation of the NMDAR, AMPA pathway and/or key active metabolites of AV-101 may achieve therapeutic benefit.
VistaStem Therapeutics is VistaGen's wholly owned subsidiary focused on applying human pluripotent stem cell 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 Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful launch, continuation and results of the NIMH's Phase 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, 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.
Irish researchers ‘cut risk of heart failure with one injection’ – Irish Times
Sat, Apr 29, 2017, 01:00 Updated: Sat, Apr 29, 2017, 10:12
Irish cardiologists have found a way to repair damaged cardiac muscle and reduce the risk of future heart failure by injecting a growth promoter into the hearts of heart attack sufferers. Photograph: Getty Images
A team of Irish cardiologists have shown that injecting an insulin-like growth promoter into the hearts of patients who have suffered a severe heart attack can repair damaged cardiac muscle and reduce the risk of future heart failure.
Prof Noel Caplice, Chair of Cardiovascular Sciences at University College Cork, and his cardiologist colleagues at Cork University Hospital successfully tested the growth factor in a clinical trial involving 47 patients who presented at the Cork hospital after experiencing heart attacks.
Prof Caplice said 20 per cent of people who suffer heart attacks have severe ongoing difficulties because of lasting damage to heart muscle even after the best current therapies.
After you have a heart attack, regardless whether you treat it with a stent or whatever, about 20 per cent of patients go on to have poor remodelling heart muscle cells die, you get scar tissue forming and the heart tends to expand and dilates, a bit like a balloon, and you get thinned-out heart muscle.
With that poor remodelling of the heart, the heart as a structure performs much worse, it doesnt work very well in terms of its function that leads to a substantial number of those patients going on to suffer heart failure with an increased risk of death, he said.
However, 10 years ago, Prof Caplice and his team began looking at using stem cells as a means of repairing damaged tissue and they found a protein within the stem cells, IGF 1, previously used to treat congenital dwarfism and growth problems, was leading to the repair of damaged heart muscle.
IGF 1 acts differently to insulin in that it acts on a different receptor in the body and when we inject it, it gets into the heart tissue and it basically stimulates receptors on the surface of the cardiac cells and in about 30 minutes, it sends a survival signal to the heart muscles cells, he said.
What we discovered from the stem cell study was that the concentration of the factor was extremely low so what we did was that we took the purified factor and in studies with pigs we injected them in the context of a heart attack and we found these major remodelling benefits.
Those animal tests were funded by Science Foundation Ireland but four years ago the Health Research Board came on board and the two bodies provided a 1 million grant to allow the treatment be trialled on humans.
Working with a 25-strong team incorporating cardiologists, radiologists, MRI specialists and nurses, Prof Caplice was able to incorporate the IGF 1 trials into the treatment of patients attending CUH with severe cardiac events and over the past three years have trialled it on 47 patients.
Patients received two different low-dose preparations of insulin-like growth factor or placebo in a randomised double-blinded clinical trial, with results showing those who received the higher dose had improved remodelling of their heart muscle in the two-month follow-up after their heart attack.
Prof Caplice said the CUH trials, the results of which he will present at a European Society of Cardiology conference in Paris on Saturday, were the first use of IGF 1 in human hearts and part of its attractiveness was its low dosage ensuring minimal side effects while improving cardiac structure.
Among the beneficiaries was John Nolan from New Ross who suffered a heart attack in December 2014. I feel I was blessed to be asked to be involved; I had confidence that good would come from it, in terms of how they explained it to me. Looking back on it now, I feel it was the right choice.
For Prof Caplice, the challenge now is to expand the trials to several hundred patients possibly across different countries and different healthcare systems to see if the IGF 1 treatment is globally applicable which, if proven to be the case, could lead to regulatory approval within five years.
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Irish researchers 'cut risk of heart failure with one injection' - Irish Times
Irish cardiologists pioneer new treatment for heart patients – Irish Times
Irish cardiologists have found a way to repair damaged cardiac muscle and reduce the risk of future heart failure by injecting a growth promoter into the hearts of heart attack sufferers. Photograph: Getty Images
A team of Irish cardiologists have shown that injecting an insulin-like growth promoter into the hearts of patients who have suffered a severe heart attack can repair damaged cardiac muscle and reduce the risk of future heart failure.
Prof Noel Caplice, Chair of Cardiovascular Sciences at University College Cork, and his cardiologist colleagues at Cork University Hospital successfully tested the growth factor in a clinical trial involving 47 patients who presented at the Cork hospital after experiencing heart attacks.
Prof Caplice said 20 per cent of people who suffer heart attacks have severe ongoing difficulties because of lasting damage to heart muscle even after the best current therapies.
After you have a heart attack, regardless whether you treat it with a stent or whatever, about 20 per cent of patients go on to have poor remodelling heart muscle cells die, you get scar tissue forming and the heart tends to expand and dilates, a bit like a balloon, and you get thinned-out heart muscle.
With that poor remodelling of the heart, the heart as a structure performs much worse, it doesnt work very well in terms of its function that leads to a substantial number of those patients going on to suffer heart failure with an increased risk of death, he said.
However, 10 years ago, Prof Caplice and his team began looking at using stem cells as a means of repairing damaged tissue and they found a protein within the stem cells, IGF 1, previously used to treat congenital dwarfism and growth problems, was leading to the repair of damaged heart muscle.
IGF 1 acts differently to insulin in that it acts on a different receptor in the body and when we inject it, it gets into the heart tissue and it basically stimulates receptors on the surface of the cardiac cells and in about 30 minutes, it sends a survival signal to the heart muscles cells, he said.
What we discovered from the stem cell study was that the concentration of the factor was extremely low so what we did was that we took the purified factor and in studies with pigs we injected them in the context of a heart attack and we found these major remodelling benefits.
Those animal tests were funded by Science Foundation Ireland but four years ago the Health Research Board came on board and the two bodies provided a 1 million grant to allow the treatment be trialled on humans.
Working with a 25-strong team incorporating cardiologists, radiologists, MRI specialists and nurses, Prof Caplice was able to incorporate the IGF 1 trials into the treatment of patients attending CUH with severe cardiac events and over the past three years have trialled it on 47 patients.
Patients received two different low-dose preparations of insulin-like growth factor or placebo in a randomised double-blinded clinical trial, with results showing those who received the higher dose had improved remodelling of their heart muscle in the two-month follow-up after their heart attack.
Prof Caplice said the CUH trials, the results of which he will present at a European Society of Cardiology conference in Paris on Saturday, were the first use of IGF 1 in human hearts and part of its attractiveness was its low dosage ensuring minimal side effects while improving cardiac structure.
Among the beneficiaries was John Nolan from New Ross who suffered a heart attack in December 2014. I feel I was blessed to be asked to be involved; I had confidence that good would come from it, in terms of how they explained it to me. Looking back on it now, I feel it was the right choice.
For Prof Caplice, the challenge now is to expand the trials to several hundred patients possibly across different countries and different healthcare systems to see if the IGF 1 treatment is globally applicable which, if proven to be the case, could lead to regulatory approval within five years.
Read more:
Irish cardiologists pioneer new treatment for heart patients - Irish Times
$10 million settlement over alleged misconduct in Boston heart stem cell lab – Science Magazine
Brigham and Women's Hospital in Boston.
BRIAN SNYDER/REUTERS/Newscom
By Kelly ServickApr. 27, 2017 , 5:00 PM
A research misconduct investigation of a prominent stem cell lab by the Harvard Universityaffiliated Brigham and Womens Hospital (BWH) in Boston has led to a massive settlement with the U.S. government over allegations of fraudulently obtained federal grants. As Retraction Watch reports, BWH and its parent health care system have agreed to pay $10 million to resolve allegations that former BWH cardiac stem cell scientist Piero Anversa and former lab members Annarosa Leri and Jan Kajstura relied on manipulated and fabricated data in grant applications submitted to the U.S. National Institutes of Health (NIH).
A statement from the U.S. Attorneys Office for the District of Massachusetts released today notes that it was BWH itself that shared the allegations against Anversas lab with the government. The hospital had been conducting its own probe into the Anversa lab since at least 2014, when a retraction published in the journal Circulation revealed the ongoing investigation. The hospital has not yet released any findings.
In 2014, Anversa and Leri sued Harvard and BWHalong with BWH President Elizabeth Nabel and Gretchen Brodnicki, Harvards dean for faculty and research integrityfor launching and publicizing the investigation that they claimed wrongfully damaged their careers. In their complaint, they acknowledged fabricated data in the Circulation paper and altered figures in a 2011 paper for whichThe Lancethas published an expression of concern. But they claimed that Kajstura had altered data without their knowledge. (Anversa and Leris recent papers list their institution as Swiss Institute for Regenerative Medicine, Retraction Watch notes.)
In July 2015, a federal district court judge dismissed the lawsuit, ruling that the plaintiffs had to first air their grievances with the federal Office of Research Integrity, which handles misconduct investigations at NIH-funded labs.
Grant fraud cases against universities rarely involve research misconduct, and most are brought by whistleblowers who stand to claim a share of any returned funds. Despite the high penalty, BWH gets praise from the Department of Justice in todays announcement for self-disclosing the allegations and for taking steps to prevent future recurrences of such conduct.
But the result is confusing and potentially discouraging, says Ferric Fang, a microbiologist at the University of Washington in Seattle, who has published several analyses of retractions, misconduct, and the scientific enterprise. It sounds as if the researchers themselves were found to have engaged in improper practices, but the institution is on the hook for the settlement. The decision deserves greater clarification, he says, or it could discourage other institutions from being as forthcoming in the future.
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$10 million settlement over alleged misconduct in Boston heart stem cell lab - Science Magazine
3D Printed Patches seeded with cells to repair cardiac tissue after heart attacks – BSA bureau (press release)
The patches may be effective at helping to restore the heart following a myocardial infarction, as the heart isnt able to restore lost cells on its own. The patches may be effective at helping to restore the heart following a myocardial infarction, as the heart isnt able to restore lost cells on its own.
A team of researchers from University of Minnesota-Twin Cities, University of Wisconsin-Madison, and University of Alabama-Birmingham have developed a technique for 3D printing cardiac patches seeded with living cells. The patches may be effective at helping to restore the heart following a myocardial infarction, as the heart isnt able to restore lost cells on its own.
The technology has already been tested on a mouse model following an induced heart attack in which cardiac function wa significantly improved in four weeks following the application of the patch.
The patch is structurally based on how proteins naturally assemble within cardiac tissue. A highly detailed technique called multiphoton-excited 3D printing was used to create an extracellular matrix that was then seeded with about 50,000 cardiomyocytes, smooth muscle cells, and endothelial cells obtained from human-induced pluripotent stem cells.
The patch began beating on its own only a day after placing the cells and calcium transients, which are intercellular signaling mechanisms, were detected and increased over the following week.
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3D Printed Patches seeded with cells to repair cardiac tissue after heart attacks - BSA bureau (press release)
VistaGen Therapeutics Announces Peer-Reviewed Publication in … – Yahoo Finance
SOUTH SAN FRANCISCO, CA--(Marketwired - April 27, 2017) - VistaGen Therapeutics Inc. (VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, announced today the peer-reviewed publication of nonclinical studies of the effects of AV-101 (4-Cl-KYN), its CNS prodrug candidate, in four well-established nonclinical models of pain.
The publication, titled: "Characterization of the effects of L-4-chlorokynurenine on nociception in rodents," by lead author, Tony L. Yaksh, Ph.D., and co-authors, Robert Schwarcz, Ph.D. and H. Ralph Snodgrass, Ph.D., was recently published in The Journal of Pain (DOI: 10.1016/j.jpain.2017.03.014) and is available online at http://www.jpain.org/article/S1526-5900(17)30552-7/abstract.
"In these studies, AV-101 was found to have robust anti-nociceptive effects, similar to gabapentin, but with a better side effect profile in several pre-clinical models of hyperalgesia and allodynia, results suggest AV-101's potential for treating multiple hyperpathic pain states," reported Tony L. Yaksh, Ph.D., Professor in Anesthesiology at the University of California, San Diego (UCSD).
"In comparison to gabapentin and other agents commonly used by millions of patients battling chronic neuropathic pain, we believe AV-101 has the potential to reduce debilitating pain effectively without causing burdensome side effects. Many neuropathic pain treatments on the market today have side effects, including anxiety, depression, mild cognitive impairment and sedation. The positive results published in these studies fall in line with our goal of advancing Phase 2 clinical development of AV-101 across a broad range of CNS indications, including major depressive disorder, neuropathic pain and L-DOPA-induced dyskinesia associated with Parkinson's disease. We are optimistic that we will be able to bring to market a new generation CNS medication that would help millions of patients currently treated with therapies with inadequate efficacy and significant side effects and safety concerns," stated H. Ralph Snodgrass, Ph.D., VistaGen's President and Chief Scientific Officer.
Study Summary and Key Findings:
About AV-101
AV-101 (4-CI-KYN) is an oral CNS prodrug candidate in Phase 2 development in the U.S. as a new generation treatment for major depressive disorder (MDD). AV-101 also has broad potential utility in several other CNS disorders, including chronic 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 VistaGen
VistaGen Therapeutics, Inc. (VTGN), is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders. VistaGen's lead CNS product candidate, AV-101, is in Phase 2 development 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, and symptoms of 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.
Read More
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 Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful launch, continuation and results of the NIMH's Phase 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.
Continue reading here:
VistaGen Therapeutics Announces Peer-Reviewed Publication in ... - Yahoo Finance
Stem-cell screening finds statin alternative for hypercholesterolaemia – The Pharmaceutical Journal
Source: Shutterstock.com
Researchers have showncertain cardiac glycosides can reduce hepatocyte production of aprecursor of LDL cholesterol.
Familial hypercholesterolaemia (FH) is a rare genetic disease that affects the production of functioning low-density lipoprotein (LDL) receptors in the liver. When patients have mutations in both copies of the LDL receptor gene, they do not respond to statins and have limited pharmaceutical treatment options available because of a lack of accurate disease models.
Reporting in Cell Stem Cell on 6 April 2017[1], researchers used FH human hepatocytes derived from induced pluripotent stem cells to screen for existing drugs that might lower apolipoprotein B (apoB) a precursor of LDL cholesterol.
The team found that all nine cardiac glycosides in their drug library reduced levels of apoB in the hepatocytes. In an analysis of historical patient data, the researchers found a reduction in serum LDL-C comparable to that seen with statins in patients taking cardiac glycosides.
The researchers say the results demonstrate the potential of their stem-cell based approach for identifying new treatment candidates for inherited liver diseases.
Citation: Clinical Pharmacist, CP April 2017 online, online | DOI: 10.1211/CP.2017.20202623
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Stem-cell screening finds statin alternative for hypercholesterolaemia - The Pharmaceutical Journal
UMN research team fixes broken hearts with 3D-printed tissue patch – Minnesota Daily
A research team at the University of Minnesota found a way to heal broken hearts.
Researchers used a 3D printer to create protein patches that mimic heart tissue to treat post-heart attack scars. The research is in collaboration with the University of Wisconsin-Madison and the University of Alabama-Birmingham.
Brenda Ogle, a University biomedical engineering professor and lead researcher for the project, said she and her team have investigated proteins that surround cells in the body for 15 years. The team has been studying how the proteins also called the extracellular matrix influence stem cell behavior.
For many years, weve been trying to develop optimum formulation that can support stem cells in new cardiac [cell] types, Ogle said, adding that theyve focused on cardiac cell types to figure out a way to strengthen them after the muscle cells are damaged and die during a heart attack. Its one of the cell types in the body that cant be recovered.
The team successfully treated mice with the patches and is now planning to test the method on larger animals.
Molly Kupfer, a doctoral student who is part of Ogles team, said a heart attack occurs when there is a blockage in a primary blood vessel that delivers oxygen and nutrients to the heart.
When that happens, you have cell death in the area of the heart that doesnt receive the appropriate oxygen and nutrients, Kupfer said. Those cells that die arent able to recover."
Typically, after a heart attack, the blood clot in the heart is removed at a hospital, and if the heart has not been damaged too badly, doctors monitor the heart long-term, prescribe medicine and regularly check for signs of heart failure, Ogle said.
What you get instead after a heart attack is scar tissue forming, and that scar tissue ultimately fails, Ogle said.
Associate Professor Brenda Ogle places a 3D printed biopatch on a mouse heart in Nils Hasselmo Hall on Tuesday, April 25, 2017. Her research team induces heart attacks in mice, which causes a dead area of cardiac cells. The patch is placed in this dead zone and mimics the cells of the native heart that aren't able to be replenished on their own. "A defining moment was when the [mouse] heart started to beat, and we realized human heart pacing could be possible too," Ogle said.
Kupfer said she worked with Paul Campagnola and his lab at the University of Wisconsin to print the patches; the cells were prepared at the University of Minnesota.
Campagnola, a biomedical engineering professor, said he initially developed the underlying printing technology in 2000.
"The idea of the patch is it could actually behave like native cardiac tissue and assist the function of the heart, Kupfer said, adding that the method used to print the patches results in extremely high resolution structures.
Ogle said before applying the patch to the animal hearts theyre currently testing on, they take a scan of the scarred tissue and create a digital template for the 3D-printer to follow and print the proteins in the same pattern.
Campagnola said the patch provides a stable space for cells to grow and be implanted in damaged areas.
Cardiac cells are also added to the patch when it covers a damaged area. Ogle said it not only provides a support structure, but transplants healthy cells that will eventually become integrated into the heart, stabling it structurally and functionally.
A huge aha moment was when [the cardiac cells] started to beat on this patch synchronously and spontaneously, she said. When that happened, we realized that this could be a viable therapy for the heart, a way to replace those lost muscle cells.
Through the research group at the University of Alabama, Ogle said a study was conducted where the patch was tested on dead or dying tissue in mice hearts and the group saw improvement in the mice after four weeks.
The project was funded through a series of grants from the National Institutes of Health, the National Science Foundation with support from the University, she said.
The group has since received larger funds from the NIH to run a study using the patch on larger animals within the next year.
Ogle said it would take about 10 years until the patch can be used on human patients in a clinical setting.
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UMN research team fixes broken hearts with 3D-printed tissue patch - Minnesota Daily
A 3D-printed patch for a ‘broken’ heart – Livemint
This week: Biomedical engineering division, University of Minnesota
Three-dimensional or 3D printing technology, which has been around for almost three decades, routinely makes headlines. Not surprising, given that the so-called Fabbers, or personal manufacturing machines3D printers come under this categorynow not only make jewellery and toothbrushes, but also football boots, racing-car parts, custom-designed cakes, guns, human organs, houses and plane parts.
3D printing can be used to save lives too. Consider this. During a heart attack, the muscle cells of the heart do not get enough blood. Hence, they die. Our bodies cant replace these dead cells, so the body leaves a scar tissue in that area of the heart. This puts the person at risk of heart failure in the future.
A team of biomedical engineering researchers, led by the University of Minnesota (Umn.edu), has created a laser 3D-bioprinted patch to address the issue and help heal the scarred heart tissue after a heart attack. Three-dimensional bioprinting is the process of creating cell patterns in a confined space using 3D printing technologies.
The researchers successfully used this technique to incorporate stem cells (cells capable of renewing themselves through cell division, sometimes after long periods of inactivity) derived from adult human heart cells in a dish in the lab.
When the cell patch was placed on a mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Since the patch was made from stem cells and structural proteins (that do most of the work in cells and are required for the structure, function, and regulation of the bodys tissues and organs) belonging to the heart, it became part of the heart and was absorbed into the body, requiring no further surgeries.
The discovery, which is a major step forward in treating patients with tissue damage after a heart attack, was published on 14 April in Circulation Research, the journal published by the American Heart Association. The researchers have filed a patent for it.
The scientists insist that this research is different from previous ones in that the patch is modelled after a digital, 3D scan of the structural proteins of the heart tissue. The digital model is made into a physical structure by 3D printing, further integrating cardiac cell types derived from stem cells. Only with 3D printing of this type, explain the researchers, can we achieve the 1 micron resolution needed to mimic structures of native heart tissue.
The scientists say they are already beginning the next step to develop a larger patch that they will test on a pig heart, which is similar in size to a human heart. Of course, the real success will be known only when human trials take place.
3D printing belongs to a class of techniques known as additive manufacturing, or building objects layer by layer. The most common household 3D-printing process involves a print head, which allows for any material to be extruded or squirted through a nozzle. There are several additive processes, including selective laser sintering, direct metal-laser sintering, fused deposition modelling, stereolithography and laminated-object manufacturing. All of them differ in the way layers are deposited to create the 3D objects.
Meanwhile, the concept of 4D printing, which allows materials to self-assemble into 3D structures, and was initially proposed by Skylar Tibbits of the Massachusetts Institute of Technology (MIT) in April 2013, is also showing promise.
Lab Watch is the Lounge guide to emerging tech from around the world .
First Published: Fri, Apr 21 2017. 02 57 PM IST
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A 3D-printed patch for a 'broken' heart - Livemint
3D-printed Patch Can Help Mend a ‘Broken’ Heart – Technology Networks
Technology Networks | 3D-printed Patch Can Help Mend a 'Broken' Heart Technology Networks The digital model is made into a physical structure by 3D printing with proteins native to the heart and further integrating cardiac cell types derived from stem cells. Only with 3D printing of this type can we achieve one micron resolution needed to ... |
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3D-printed Patch Can Help Mend a 'Broken' Heart - Technology Networks
Outsourced Ion Channel Testing Trends – Technology Networks
Introduction
Ion channels play a key role in regulating electrical activity in excitable cells, and many additional roles in non-excitable tissues. They are important therapeutic targets in a range of indications including arrhythmia, hypertension, local anaesthesia, pain, stroke, epilepsy, depression, bipolar disorder, COPD, autoimmune disorders and diabetes. Not only are ion channels major drug targets, but they are also important indicators for drug safety. Indeed, many drugs withdrawn from the market due to cardiac related adverse effects have been shown to block the human ether-a-go-go (hERG) ion channel, which delays repolarization of the cardiac action potential and can result in a potentially fatal arrhythmia known as Torsades de Pointes (TdP).
Performing high throughput screening (HTS) or lead optimization against a target of interest, identification of a compounds target specificity by selectivity profiling, and checking for safety liabilities/risk assessment are all critical steps in the drug discovery process. Ion channel testing has evolved considerably in recent years with third generation automated patch clamping (APC) platforms addressing both voltage and ligand-gated channels at high throughput (HT) and at higher seal resistances. These newer HT APC platforms have allowed fee-for-service providers the possibility to offer cost-effective high quality outsourced ion channel primary screening and selectivity profiling for drug discovery, this is in addition to fluorescent-based assays and lower throughput conventional (manual patch) electrophysiology.
Read:automated patch-clamping trends
Most service providers that offer selectivity profiling have a large collection of stably transfected ion channel cell lines from which they assemble channel panels. Many service providers have also adapted and validated these cell lines for use on HT APC systems, some also sell their cell lines commercially. Providers of outsourced ion channel testing fall into 2 categories: 1) specialty CROs (i.e. providers with offerings limited to ion channel screening or ADME or animal models or clinical studies or any combination of these activities, but NOT the entire value chain); and 2) single-source or integrated CRO (i.e. a one-stop shop offering all activities).
In July 2016, HTStec undertook a market survey on outsourced ion channel testing mainly among research labs in pharma, biotech and academia. The survey was initiated by HTStec as part of its tracking of life science marketplaces and to update their previous outsourced ion channel testing trends report (published May 2013). The main objectives were to comprehensively document current use of and potential interest in outsourcing ion channel primary screening, selectivity profiling and safety liability testing. The survey also investigated access to stably transfected cell lines and future purchasing plans. The aim was to compile a reference document on outsourced ion channel testing, which could be directly compared with HTStecs previous 2013 report. This article contains selected findings from the HTStec market report, Outsourced Ion Channel Testing Trends 2016.
It is intended to provide the reader with a brief insight into recent market trends. It covers only 11 out of the 32 original questions detailed in the full report. The full published report should be consulted to view the entire dataset, details of the breakdown of the responses for each question, its segmentation and the estimates for the future.
Outsourced primary screening of ion channels Only a minority (32%) of survey respondents have outsourced the primary screening of ion channels to date and 18% of survey respondents had no foreseeable interest in outsourcing primary screening over the coming years. Where interested, the platforms for the primary screening of ion channels survey respondents most want to outsource to fee-for-service providers are given in Figure 1. This showed that automated patch-clamp (APC) was the most wanted platform (46%). This was followed by fluorescence-based assays (e.g. FLIPR/Hamamatsu FDSS) (19%), manual patch clamp (16%), multi-electrode array assays (MEA) (12%), and then membrane binding assays (6%). In contrast, the most used platform for primary screening of ion channels undertaken in- house is fluorescence-based assays.
Figure 1. Ion Channel Primary Screening Platform Respondents Want To Outsource At A Fee-For-Service Provider. Outsourced selectivity profiling of ion channelsMost (61%) survey respondents outsourced selectivity profiling of ion channels in 2016 and only a minority (9%) of survey respondents do not anticipate outsourcing over the coming years. The platforms for selectivity profiling of ion channels survey respondents most want to outsource to fee-for-service providers are presented in Figure 2. This showed that the preferred platform for selectivity profiling of ion channels to be accessed at service providers was automated patch-clamp (APC) (47%). This was followed by: manual patch clamp (28%); fluorescence-based assays (e.g. FLIPR/Hamamatsu FDSS) (11%); multi-electrode array assays (MEA) (8%); and membrane binding assays (6%).
Figure 2. Ion Channel Selectivity Profiling Platform Respondents Want To Use/Access At A Fee-For-Service Provider.
The stage in the drug discovery process where survey respondents most want outsourced selectivity profiling is shown in Figure 3. This showed that most (24%) respondents want to outsource selectivity profiling after hits-to-leads (lead optimization). This was followed by either: after secondary/counter screening or after primary screening/HTS (both 15%); after some initial selectivity profiling results generated in- house (14%); no fixed stage, we want to profile lead compounds from other therapeutic areas (12%); and then, when about to start IND enabling (3%).
Figure 3. When Respondent's Want To Outsource Selectivity Profiling.
The preferred way of selecting particular assays for outsourced ion channel selectivity profiling are given in Figure 4. This showed that respondents ranked selection by target as their most preferred way of choosing assays when deciding on ion channel selectivity profiling. This was followed by selection by family, selection by testing platform, and then selection by therapeutic area.
Figure 4. Preferred Way Of Selecting Assays For Ion Channel Selectivity Profiling.
The ion channel panels of most interest when considering outsourced selectivity profiling are presented in Figure 5. This showed that a cardiac channel panel was most wanted for selectivity profiling (26%). This was followed by a cardiovascular channel panel (16%), and then a pain-inflammation channel panel (13%). All others panel had less than 10% interest.
Figure 6. What Motivates Selection Of An Ion Channel Selectivity Profiling Provider.
Outsourced ion channel safety liability testing The aspect of ion channel safety liability testing survey respondents most want to outsource today are given in Figure 7. This showed that cardiac ion channel panel assays - automated patch clamp; hERG IC50 assay - non-GLP; and hERG ion channel assays were the most wanted assays (all with 41%). They were followed by hERG IC50 assay GLP (30%); and then cardiac ion channel panel assays - manual patch clamp and hERG screening assay (both 25%). Least wanted were stem cell-derived human cardiomyocytes assays (field potential, MEA, impedance, IcaICa, L activator assay).
Figure 7. Aspects Of Ion Channel Safety Liability Testing Outsourced. What motivates end-user selection of an ion channel safety liability provider is reported in Figure 8. This showed that cutting-edge gold standard assays were ranked as what most motivates their selection of an ion channel safety liability provider. This is very closely followed by comprehensive nature of the tests and assays offered, and then expertise in predicting cardiac risk and price. Ranked as least influential was Involvement in comprehensive in vitro proarrhythmia (CiPA) working groups.
Figure 8. What Motivates Selection Of An Ion Channel Safety Liability Provider. Spending on ion channel testing servicesHow survey respondents spend on outsourced ion channel testing services is broken down and presented in Figure 9. This showed that the biggest proportion (29%) of survey respondents 2016 outsourced ion channel testing budget was spent on selectivity profiling, this was followed by primary screening (25%); GLP Safety liability testing against hERG (16%); other safety testing (12%); non-GLP Safety liability testing against hERG (11%); and then assays fulfilling CiPA recommendations (7%).
Figure 9. Breakdown Of Current (2016) Outsourced Ion Channel Testing Budget.
The most used fee-for-service providers of ion channel testing services are reported in Figure 10. This showed that Eurofins (33%) was the most used fee-for-service provider of ion channel testing. It was very closely followed by Charles River (30%) and then more distantly by Thermo Fisher Scientific (9%), Aviva Biosciences (4%), SB Drug Discover (4%)y and Wuxi Pharmatech (4%). All other providers (totaling 17%) each had less than 4% share of use. This provider selection should not be confused as a true market share, it is not based on the actual $ value of services purchased, but on which provider survey respondents indicated they have most used over the past 12 months.
Figure 10. Most Used Fee-For-Service Providers Of Ion Channel Testing Services.
The importance (influence on provider selection) of an ion channel testing fee-for-service provider offering specific services is detailed in Figure 11. This showed the survey respondents rated most highly access to selectivity profiling (ion channels only) as the offering an ion channel service provider must provide to be worthy of consideration. This was followed by selectivity profiling (ion channels, GPCRs & kinases); and then assays fulfilling CiPA recommendations and GLP safety liability testing. Rated least wanted (not needed) was med chem around lead series (Figure 10).
Figure 11. Importance Of An Ion Channel Testing Provider Offering The Following Services.
Overall the use of outsourced ion channels testing services, particularly for selectivity profiling, is the preferred option for many drug discovery groups. However, the implementation of the CiPA initiative is expected to change the focus in nonclinical cardiac safety assessment by replacing the early hERG assessment (non-GLP) with an evaluation of compounds against multiple cardiac currents (APC); in silico modeling of cardiac action potentials; and the use of stem cell-derived human cardiomyocyte assays (e.g. MEA), as a multicellular test system that recapitulates the physiological properties of the human heart (e.g. with ECG-like field potentials). CiPA does however not displace GLP hERG or GLP in vivo ECG in a large animal which will still be needed for IND enabling, and are key services available at CROs. It will be interesting to see how outsourced providers of in channel testing services adapt to the changing regulatory requirements and the emergence of new in vitro screening technologies and approaches over the coming years.
DISCLAIMER: HTStec Limited has exercised due care in compiling and preparing these Selected Findings from its Report, which is based on information submitted by individuals in respondent companies. HTStec Limited has NOT verified the accuracy of this information, nor has it established respondents authority to disclose information to HTStec Limited. HTStec Limited expressly disclaims any and all warranties concerning these Selected Findings including any warranties of merchantability and/or fitness for any particular purpose, and warranties of performance, and any warranty that might otherwise arise from course of dealing or usage of trade. No warranty is either expressed or implied with respect to the use of these Selected Findings. Under no circumstances shall HTStec Limited be liable for incidental, special, indirect, direct or consequential damages or loss of profits, interruption of business, or related expenses that may arise from the use of these Selected Findings, including but not limited to those resulting from inaccuracy of the data therein.
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Outsourced Ion Channel Testing Trends - Technology Networks
Heart-healing patch has got the beat – New Atlas
Biomedical engineering Associate Professor Brenda Ogle (right) and Ph.Dstudent Molly Kupfer, with a mouse heart (Credit: Patrick OLeary, University of Minnesota)
One of the problems with heart attacks (as if there weren't enough already) is that when the heart heals afterwards, it grows scar tissue over the part of the heart that was damaged. That scar tissue never does become beating heart tissue, so it leaves the heart compromised for the rest of the patient's life. There may be hope, however, as scientists from the University of Minnesota have created a new patch that allows the heart to heal more completely.
First of all, yes, this has been done before. We have already seen experimental "heart patches" from places like the University of Tel Aviv, Brown University and MIT, which allow the heart to heal with a minimum of scar tissue growth.
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One of the things that makes this latest patch unique is the fact that it's 3D-bioprinted out of structural proteins native to the heart. It takes the form of a scaffolding-like matrix, which is subsequently seeded with cardiac cells derived from stem cells. The result is a patch of material, similar in structure and material to heart tissue, containing actual functioning heart cells as opposed to inert scar tissue.
In lab tests, one of the patches was placed on the heart of a mouse that had suffered a simulated heart attack. Within just four weeks, the scientists noted a "significant increase in functional capacity." The patch was ultimately absorbed by the body, so no additional surgeries were required to remove it after its job was done.
"We were quite surprised by how well it worked given the complexity of the heart," says associate professor Brenda Ogle, who is leading the research. "We were encouraged to see that the cells had aligned in the scaffold and showed a continuous wave of electrical signal that moved across the patch."
A larger patch is now in the works, which will be tested on a pig heart.
Other institutions involved in the study include the University of Wisconsin-Madison and University of Alabama-Birmingham. A paper on the research was recently published in the journal Circulation Research.
Source: University of Minnesota
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Heart-healing patch has got the beat - New Atlas
First participant treated in trial of stem-cell therapy for heart failure – Medical Xpress
April 18, 2017 by Gian Galassi
A research team at University of Wisconsin School of Medicine and Public Health has treated its first patient in an innovative clinical trial using stem cells for the treatment of heart failure that develops after a heart attack.
The trial is taking place at University Hospital, one of three sites nationwide currently enrolling participants. The investigational CardiAMP therapy is designed to deliver a high dose of a patient's own bone-marrow cells directly to the point of cardiac injury to potentially stimulate the body's natural healing response.
The patient experience with the trial begins with a cell-potency screening test. Patients who qualify for therapy are scheduled for a bone-marrow aspiration. The bone marrow is then processed on-site and subsequently delivered directly to the damaged regions in a patient's heart in a minimally invasive procedure.
"Patients living with heart failure experience a variety of negative symptoms that can greatly impact their day-to-day life," said UW Health cardiologist Dr. Amish Raval, associate professor of medicine and one of the principal investigators for the trial. "By being at the forefront of research for this debilitating condition, we look forward to studying the potential of this cell therapy to impact a patient's exercise capacity and quality of life."
The primary outcome to be measured is the change in distance during a six-minute walk 12 months after the initial baseline measurement.
Heart failure commonly occurs after a heart attack, when the heart muscle is weakened and cannot pump enough blood to meet the body's needs for blood and oxygen. About 790,000 people in the U.S. have heart attacks each year. The number of adults living with heart failure increased from about 5.7 million (2009-2012) to about 6.5 million (2011-2014), and the number of adults diagnosed with heart failure is expected to dramatically rise by 46 percent by the year 2030, according to the American Heart Association (AHA).
The CardiAMP Heart Failure Trial is a phase III study of up to 260 patients at up to 40 centers nationwide. Phase III trials are conducted to measure effectiveness of the intervention, monitor side effects and gather information for future use of the procedure. Study subjects must be diagnosed with New York Heart Association (NYHA) Class II or III heart failure as a result of a previous heart attack.
Information about eligibility or enrollment in the trial is available at http://www.clinicaltrials.gov, or through a cardiologist.
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First participant treated in trial of stem-cell therapy for heart failure - Medical Xpress
Scientists identify mechanisms of early heart development in Zebrafish – Biotechin.Asia
A female specimen of a zebrafish (Danio rerio) breed with fantails
Cardiovascular disease is one of the leading causes of death in the world with approximately 30% of global mortality attributed to it.Cardiovascular disease conditions lead to damage of cardiac muscle cells resulting in defective heart function.
Stem cell therapy, though a relatively young science, is one of the upcoming treatment options for such diseases in the near future. In principle, stem cells from embryos can be made to differentiate into many functional cell types including heart cells, which can be effectively used to replace damaged cells in heart patients. To achieve this, scientists are constantly trying to understand the developmental process by which the heart is formed from various progenitors in a growing embryo. Once we understand this pathway at an organismal level, efforts can be made to use these stem cells for regenerative medicine.
A team of scientists led by Bruno Reversade from Singapore and Ian Scott from the University of Toronto have come together to study heart development in the Zebrafish model.
Zebrafish, scientifically called Danio rerio, is one of the powerful models for studying various organ functions. Although there are major structural differences between zebrafish and humans, there are strong similarities at the genetic and morphological levels. One of the biggest advantages of using zebrafish is that unlike mice, rats or monkeys, zebrafish embryos are transparent and hence provide a tractable system for visualizing these important developmental processes in situ.
During embryonic development, early heart development requires the activation of one of the important signaling pathways called Nodal or TGF pathway. Depending on the activation levels of Nodal, different cells become different stem cell types. Hence, there has to be a mechanism for fine-tuning of this signaling to produce these activity thresholds. Scientists from these two groups have recently identified the candidates involved in this fine-tuning.
Researchers recently identified a mutation, which leads to zebrafish with no heart at all. This suggests that this mutation somehow alters an early developmental process in heart formation. Interestingly, this gene encodes for a protein called Apelin receptor. So how does the Apelin receptor affect heart development? Scientists revealed that mutation in this receptor caused lower levels of Nodal signaling in mutant embryos as compared to the normal ones, thus failing to induce the formation of cardiac stem cells. When Nodal activity is artificially elevated in embryos that lack the Apelin receptor, they were able to develop hearts further confirming the role of Apelin receptor in this pathway.
A detailed understanding of this molecular cross-talk could help in the derivation of specific cell types from human embryonic stem cells for regenerative medicine, says Bruno Reversade, a human geneticist at the A*STAR Institute of Medical Biology, who co-led the investigation.
Further, this collaborative study showed that the Apelin receptor does not work in cells that produce or receive Nodal signals, suggesting that the Apelin receptor modulates Nodal signaling levels by acting in cells that lie between the cells that release Nodal signals and the cardiac progenitors.
In brief, this receptor functions as a distant regulator for fine-tuning the expression of the Nodal pathway during early stages of heart development ensuring proper cardiac development. One important area of future study is to determine whether modulating the levels of this receptor can prove useful for patients with various heart disorders.
Original article can be found here: https://elifesciences.org/content/5/e13758
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Scientists identify mechanisms of early heart development in Zebrafish - Biotechin.Asia
Regenexx Network Using Regenerative Medicine Technologies in Interventional Orthopedics to Treat Pain – OrthoSpineNews
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BROOMFIELD, Colo., April 17, 2017 /PRNewswire/ Interventional orthopedics in pain medicine practice was recently published by Elsevier as a chapter in Techniques in Regional Anesthesia and Pain Management. The chapter, authored by Regenexx founder Christopher J. Centeno, MD examines less invasive ways to treat orthopedic pain and injuries through autologous biologics, such as stem cells and platelet rich plasma (PRP), and the shift from surgical orthopedics to interventional orthopedics.
Interventional orthopedics utilizing advanced technologies, such as ultrasound and X-ray guidance, precise percutaneous injections of autologous biologics, and bone marrow concentrate, (BMC) expand nonsurgical options in the field of orthopedics. Citing the dramatic reduction in cardiac surgery rates since the adoption of the specialty interventional cardiology, the authors reveal, We are poised on the brink of the same change in orthopedic care. The authors also state, The field of autologous biologics has the potential to alter the playing field of orthopedic care by allowing percutaneous injections to replace the need for more invasive orthopedic surgeries.
The chapter covers three important tenets in the developing field that will allow Interventional Orthopedics to alter traditional orthopedic care in the future. First is the rapid expansion of injectates (material being injected), such as stem cells and PRP, that can help heal damaged tissue and that can effectively treat musculoskeletal tissues. Second is the precise image-guided placement of those injectates into those damaged tissues. And third is the development of new tools that will advance this regenerative-medicine technology. The chapter also highlights research that supports the use of bone marrow stem cells and the importance of education standards and organization, training, and retraining of physicians to meet these standards.
The full chapter Interventional orthopedics in pain medicine practice can be found online at http://www.sciencedirect.com/science/article/pii/S1084208X16300052.
Christopher J. Centeno, MD, is the CEO of Regenexx and an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. Dr. Centeno maintains an active research-based practice and has multiple publications listed in the US National Library of Medicine.He has also served as editor-in-chief of a medical research journal dedicated to traumatic injury and is one of the few physicians in the world with extensive experience in the culture expansion of and clinical use of adult stem cells to treat orthopedic injuries.
MEDIA CONTACT Mark Testa 155014@email4pr.com (303) 885-9630
SOURCE Regenexx
Drue has been helping orthopedic companies overcome challenges since starting the firm in 2000. Direct orthopedic industry experience informs Drues perspective on who is best suited to take companies to the next level. A father of four, Drue strives to live a life of integrity and commitment to excellence. Prior to starting TDG, Drue was at Zimmer for 10 years as a Multiple President's Club Achieving Sales Representative before being recruited by Stryker as Branch Manager of the Arizona Branch where he built an award winning team in Reconstruction, Trauma & Spine.
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Regenexx Network Using Regenerative Medicine Technologies in Interventional Orthopedics to Treat Pain - OrthoSpineNews
3D-Printed Patch Can Help Mend a ‘Broken’ Heart – Lab Manager | News (press release) (blog)
Photo courtesy of the University of Minnesota
MINNEAPOLIS/ST. PAUL A team of biomedical engineering researchers, led by the University of Minnesota, has created a revolutionary 3D-bioprinted patch that can help heal scarred heart tissue after a heart attack. The discovery is a major step forward in treating patients with tissue damage after a heart attack.
The research study was published Apr. 14 inCirculation Research, a journal published by the American Heart Association. Researchers have filed a patent on the discovery.
According to the American Heart Association, heart disease is the No. 1 cause of death in the U.S. killing more than 360,000 people a year. During a heart attack, a person loses blood flow to the heart muscle and that causes cells to die. Our bodies cant replace those heart muscle cells so the body forms scar tissue in that area of the heart, which puts the person at risk for compromised heart function and future heart failure.
In this study, researchers from the University of Minnesota-Twin Cities, University of Wisconsin-Madison, and University of Alabama-Birmingham used laser-based 3D-bioprinting techniques to incorporate stem cells derived from adult human heart cells on a matrix that began to grow and beat synchronously in a dish in the lab.
Watch a video of the cells beating on the patch.
Video credit:College of Science and Engineering, UMN
When the cell patch was placed on a mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Since the patch was made from cells and structural proteins native to the heart, it became part of the heart and absorbed into the body, requiring no further surgeries.
Related Article:3D-Printed Guide Helps Regrow Complex Nerves After Injury
This is a significant step forward in treating the No. 1 cause of death in the U.S., said Brenda Ogle, an associate professor of biomedical engineering at the University of Minnesota. We feel that we could scale this up to repair hearts of larger animals and possibly even humans within the next several years.
A team of biomedical engineering researchers has created a revolutionary 3D-bioprinted patch that can help heal scarred heart tissue after a heart attack. Two of the researchers involved are biomedical engineering associate professor Brenda Ogle (right) and PhD student Molly Kupfer (left).Photo credit: Patrick OLeary, University of MinnesotaOgle said that this research is different from previous research in that the patch is modeled after a digital, three-dimensional scan of the structural proteins of native heart tissue. The digital model is made into a physical structure by 3D printing with proteins native to the heart and further integrating cardiac cell types derived from stem cells. Only with 3D printing of this type can we achieve one micron resolution needed to mimic structures of native heart tissue.
We were quite surprised by how well it worked given the complexity of the heart, Ogle said. We were encouraged to see that the cells had aligned in the scaffold and showed a continuous wave of electrical signal that moved across the patch.
Ogle said they are already beginning the next step to develop a larger patch that they would test on a pig heart, which is similar in size to a human heart.
The research was funded by the National Science Foundation, National Institutes of Health, University of Minnesota Lillehei Heart Institute, and University of Minnesota Institute for Engineering in Medicine.
In addition to Ogle, other biomedical engineering researchers who were part of the team include Molly E. Kupfer, Jangwook P. Jung, Libang Yang, Patrick Zhang, and Brian T. Freeman from the University of Minnesota; Paul J. Campagnola, Yong Da Sie, Quyen Tran, and Visar Ajeti from the University of Wisconsin-Madison; and Jianyi Zhang, Ling Gao, and Vladimir G. Fast from the University of Alabama,
To read the full research paper entitled Myocardial Tissue Engineering With Cells Derived from Human Induced-Pluripotent Stem Cells and a Native-Like, High-Resolution, 3-Dimensionally Printed Scaffold, visit theCirculation Researchwebsite.
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3D-Printed Patch Can Help Mend a 'Broken' Heart - Lab Manager | News (press release) (blog)
Regenexx Network Using Regenerative Medicine Technologies in Interventional Orthopedics to Treat Pain – Yahoo Finance
BROOMFIELD, Colo., April 17, 2017 /PRNewswire/ -- "Interventional orthopedics in pain medicine practice" was recently published by Elsevier as a chapter in Techniques in Regional Anesthesia and Pain Management. The chapter, authored by Regenexx founder Christopher J. Centeno, MD examines less invasive ways to treat orthopedic pain and injuries through autologous biologics, such as stem cells and platelet rich plasma (PRP), and the shift from surgical orthopedics to interventional orthopedics.
Interventional orthopedics utilizing advanced technologies, such as ultrasound and X-ray guidance, precise percutaneous injections of autologous biologics, and bone marrow concentrate, (BMC) expand nonsurgical options in the field of orthopedics. Citing the dramatic reduction in cardiac surgery rates since the adoption of the specialty interventional cardiology, the authors reveal, "We are poised on the brink of the same change in orthopedic care." The authors also state, "The field of autologous biologics has the potential to alter the playing field of orthopedic care by allowing percutaneous injections to replace the need for more invasive orthopedic surgeries."
The chapter covers three important tenets in the developing field that will allow Interventional Orthopedics to alter traditional orthopedic care in the future. First is the rapid expansion of injectates (material being injected), such as stem cells and PRP, that can help heal damaged tissue and that can effectively treat musculoskeletal tissues. Second is the precise image-guided placement of those injectates into those damaged tissues. And third is the development of new tools that will advance this regenerative-medicine technology. The chapter also highlights research that supports the use of bone marrow stem cells and the importance of education standards and organization, training, and retraining of physicians to meet these standards.
The full chapter "Interventional orthopedics in pain medicine practice" can be found online at http://www.sciencedirect.com/science/article/pii/S1084208X16300052.
Christopher J. Centeno, MD, is the CEO of Regenexx and an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. Dr. Centeno maintains an active research-based practice and has multiple publications listed in the US National Library of Medicine.He has also served as editor-in-chief of a medical research journal dedicated to traumatic injury and is one of the few physicians in the world with extensive experience in the culture expansion of and clinical use of adult stem cells to treat orthopedic injuries.
MEDIA CONTACT Mark Testa 155014@email4pr.com (303) 885-9630
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Regenexx Network Using Regenerative Medicine Technologies in Interventional Orthopedics to Treat Pain - Yahoo Finance
CESCA Therapeutics to Present at the 2017 International Symposium of Translational Medicine in Stem Cell … – GlobeNewswire (press release)
April 11, 2017 07:15 ET | Source: Cesca Therapeutics Inc.
RANCHO CORDOVA, Calif., April 11, 2017 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that Dr. Xiaochun (Chris) Xu, Chairman and Interim Chief Executive Officer and Chairman of Boyalife Group, will present an overview of the Companys cardiovascular clinical research program at the 2017 International Symposium of Translational Medicine in Stem Cell Myocardial Repair, being held April 10-12, 2017 at the Hope Hotel in Shanghai, China.
Details of the presentation are as follows:
Despite recent therapeutic and surgical advances, the effects of peripheral arterial disease, including heart attack and critical limb ischemia (CLI), remain among the worlds leading causes of morbidity and mortality and represent a rapidly escalating public health crisis, noted Dr. Xu. I look forward to presenting a review of our latest findings, including key feasibility study results and an overview of our Phase 3 Critical Limb Ischemia Rapid Stemcell Treatment (CLIRST) trial, which we believe highlight the potential of Cesca Therapeutics proprietary AutoXpress point-of-care platform to deliver autologous cell-based therapies that may represent a new paradigm in patient treatment going forward.
About the Symposium of Translational Medicine in Stem Cell Myocardial Repair
The 2017 International Symposium of Translational Medicine in Stem Cell Myocardial Repair brings together more than 650 of the worlds cardiac disease thought leaders to discuss the potential of translational and regenerative medicine in treating myocardial infarction (MI) and cardiac failure. The symposium is co-sponsored by the Shanghai Society for Cell Biology, the Institute of Health Sciences, the Shanghai Cardiovascular Disease Institute, the Guangzhou Institutes of Biomedicine and Health, and the Key Laboratory of Stem Cell Biology, Shanghai.
About Cesca Therapeutics Inc.
Cesca is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. Cesca is an affiliate of the Boyalife Group (http://www.boyalifegroup.com), a China-based industrial-research alliance among top research institutes for stem cell and regenerative medicine.
Forward-Looking Statement
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on managements current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.
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Scientists have made a 3D-printed patch that can help heal the damaged heart tissue – Tech2 (blog)
Scientists have created a revolutionary 3D-bioprinted patch that can help heal scarred heart tissue after a heart attack. The discovery is a major step forward in treating patients with tissue damage after a heart attack, researchers at University of Minnesota in the US said. During a heart attack, a person loses blood flow to the heart muscle and that causes cells to die.
Our bodies can not replace those heart muscle cells so the body forms scar tissue in that area of the heart, which puts the person at risk for compromised heart function and future heart failure. Researchers used laser-based 3D-bioprinting techniques to incorporate stem cells derived from adult human heart cells on a matrix that began to grow and beat synchronously in a dish in the lab.
When the cell patch was placed on a mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Since the patch was made from cells and structural proteins native to the heart, it became part of the heart and absorbed into the body, requiring no further surgeries. This is a significant step forward in treating the No 1 cause of death in the US, said Brenda Ogle, an associate professor at the University of Minnesota.
We feel that we could scale this up to repair hearts of larger animals and possibly even humans within the next several years, said Ogle. Ogle said that the research is different from previous ones as the patch is modelled after a digital, three- dimensional scan of the structural proteins of native heart tissue. The digital model is made into a physical structure by 3D printing with proteins native to the heart and further integrating cardiac cell types derived from stem cells.
Only with 3D printing of this type can we achieve one micron resolution needed to mimic structures of native heart tissue, researchers said. We were quite surprised by how well it worked given the complexity of the heart. We were encouraged to see that the cells had aligned in the scaffold and showed a continuous wave of electrical signal that moved across the patch, Ogle said.
Ogle said they are already beginning the next step to develop a larger patch that they would test on a pig heart, which is similar in size to a human heart. The study was published in the journal Circulation Research.
Publish date: April 16, 2017 12:57 pm| Modified date: April 16, 2017 12:57 pm
Tags: 3D-Bioprint, Brenda Ogle, cells, Heart, heart attack, heart failure, Journal Circulation Research, scientists, structural proteins, University of Minnesota
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Scientists have made a 3D-printed patch that can help heal the damaged heart tissue - Tech2 (blog)
Breakthrough in cardiac health: 3D-printed patch can help mend a ‘broken’ heart – Economic Times
WASHINGTON D.C: Scientists have developed a revolutionary 3D-bioprinted patch that could one day be used to repair damage to the human heart.
The patch can help heal scarred heart tissue after a heart attack. The discovery is a major step forward in treating patients with tissue damage after a heart attack.
The researchers from the University of Minnesota-Twin Cities, University of Wisconsin-Madison, and University of Alabama-Birmingham used laser-based 3D-bioprinting techniques to incorporate stem cells derived from adult human heart cells on a matrix that began to grow and beat synchronously in a dish in the lab.
When the cell patch was placed on a mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Since the patch was made from cells and structural proteins native to the heart, it became part of the heart and absorbed into the body, requiring no further surgeries.
"This is a significant step forward in treating the No. 1 cause of death in the U.S.," said researcher Brenda Ogle. "We feel that we could scale this up to repair hearts of larger animals and possibly even humans within the next several years."
Ogle said that this research is different from previous research in that the patch is modelled after a digital, three-dimensional scan of the structural proteins of native heart tissue. The digital model is made into a physical structure by 3D printing with proteins native to the heart and further integrating cardiac cell types derived from stem cells. Only with 3D printing of this type can we achieve one micron resolution needed to mimic structures of native heart tissue.
"We were quite surprised by how well it worked given the complexity of the heart," Ogle noted. "We were encouraged to see that the cells had aligned in the scaffold and showed a continuous wave of electrical signal that moved across the patch."
Ogle said they are already beginning the next step to develop a larger patch that they would test on a pig heart, which is similar in size to a human heart.
The research study is published in Circulation Research, a journal published by the American Heart Association.
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Breakthrough in cardiac health: 3D-printed patch can help mend a 'broken' heart - Economic Times