Category Archives: Stem Cell Human Trials

PUBLIC RELEASE DATE: 18-Mar-2014 Contact: Bei Shi shi_bei2147@126.com Society for Experimental Biology and Medicine Bei Shi, Xianping Long, Ranzun Zhao, Zhijiang Liu, Dongmei Wang and Guanxue Xu, researchers at the First Affiliated Hospital of Zunyi Medical College within the Guizhou Province of China, have reported an approach for improving the use of stem cells for improvement of infarcted heart function and damage to the arteries in the March 2013 issue of Experimental Biology and Medicine. They have discovered that mesenchymal stem cells (MSCs) transfected with a recombinant adenovirus containing the human receptor activity-modifying protein 1 (hRAMP1) gene (EGFP-hRAMP1-MSCs) when transplanted into rabbit models for both Myocardial infarction (MI) and carotid artery injury inhibit vascular smooth muscle cell (VSMC) proliferation within the neointima, and greatly improved both infarcted heart function and endothelial recovery from artery injury more efficiently than the control EGFP-MSCs. MSCs have good applicability for cell transplantation because they possess self-renewal and multiple differentiation potential. With addition of either environmental or chemical substances, MSCs can differentiate into a variety of cell types. Numerous animal experiments and small clinical trials have shown that MSC transplantation can promote the formation of new blood vessels and reduce myocardial infarct size, and diminish … Continue reading →

Course Description: Regenerative medicine focuses on harnessing the power of ones own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administrations (FDA) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (HCT/Ps) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in the industry on how such therapies should be regulated by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics. This 2-day interactive seminar on FDA regulations of regenerative medicine will cover: -How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use. -The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products. -The New Drug Application (NDA) and the Biologic License Application (BLA) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements. -The option for obtaining designation and approval as Orphan Drug Product. -Designing and conducting appropriate clinical trials to … Continue reading →

By Marcus Johnson Stem cell researchers from Harvard have been able to turn patients skin cells into neurons that can be affected by early-onset Alzheimers. Experts believe that this will make it easier to gather the results of cells affected by the disease. It is also believed that the research will make the development of new treatments a faster process. The research was published in the Human Molecular Genetics journal and headed by Tracy Young-Pearse. The data showed that peopl suffering from Alzheimers had cell mutations t similar to mutations occurring in mice. We see this mild increase in A42 in cells from patients with Alzheimer's disease, which seems to be enough to trigger disease processes, said Young-Pearse. We also see increases of a smaller species of amyloid-beta called A38, which was unexpected as it should not be very aggregation prone. We don't fully understand what it means, but it may combine with other forms of amyloid-beta to stimulate plaque formation. The researchers hope that their work can lead to new drugs that are more effective against the disease. Alzheimers drugs have had a high rate of failure during clinical trials because much of the drug development was based on … Continue reading →

In 2009, Steven Bustamante, 58, was in bad shape. A major heart attack, along with nearly every complication in the book, had led to heart failure. He called his brother from the hospital to say his goodbyes, fearing he would fall asleep and never wake up. But when he did wake up, an unfamiliar doctor from the University of Miami Miller School of Medicine was sitting in his room, offering him the opportunity to participate in a clinical trial where his heart would be injected with stem cells extracted from his bone marrow. The results were transformative. I went from being a person who probably needed a heart transplant to someone whose heart is in a normal range, Bustamante said. I dont feel like a sick person anymore, at all. Several studies at the UM Interdisciplinary Stem Cell Institute (ISCI) have shown that stem cells derived from adult bone marrow, which carry the potential to grow into various kinds of cells based on their environment, can help repair damaged heart tissue. As researchers continue to explore the potential of stem cell therapy in current and upcoming studies, they are taking what some see as early but steady strides toward changing … Continue reading →

hide captionUp till now, all babies have had two genetic parents. That could soon change. A panel of government advisers has expressed serious concerns about a controversial proposal to allow scientists to try to make babies using eggs that have been genetically altered to include DNA from another woman. Members of the Food and Drug Administration panel said they were worried that not enough research has been done to know whether the experiments would be safe. "I think there was a sense of the committee that at this particular point in time, there was probably not enough data either in animals or in vitro to conclusively move on to human trials ... without answering a few additional questions," said Dr. Evan Snyder of the Sanford-Burnham Medical Research Institute in La Jolla, Calif., chairman of the 25-member committee that met Tuesday and Wednesday. Unlike most FDA advisory panels, this group did not take a vote on whether the agency should let the experiments proceed. A similar proposal is pending in Britain. During the hearing, the panel heard from researchers at the New York Stem Cell Foundation, the Oregon Health & Science University and Newcastle University in England who have conducted preliminary … Continue reading →

A reproductive technology that taps three parents DNA as a way to eliminate hereditary diseases could reach clinical trials if the Food and Drug Administration gives the go-ahead Credit: Thinkstock/iStock Reproductive technologies that marry DNA from three individuals will receive a trial in the court of public opinion this week. Such technologies may hold promise for averting certain genetically inherited diseases passed down via mutations to mitochondria, the cells battery pack. Scientists have already had successes with this type of reproductive approach in monkeys and in human embryos, and are now eager to launch human clinical trials. First, however, they must get the green light from the U.S. Food and Drug Administration, which will convene a public hearing before an advisory committee on February 25. The technology, called oocyte modification (but sometimes nicknamed three-parent IVF), involves scooping out potentially mutated mitochondrial DNA (mtDNA) from a womans egg and replacing it with the mtDNA of an unaffected donor woman. The process is designed to prevent the transmission of some debilitating inherited mitochondrial diseases, which can result in vision loss, seizures and other maladies. Such inherited diseases, often unfortunately known by acronyms for complex medical names that include LHON, for Leber's Hereditary … Continue reading →

Current ratings for: 'Largest ever' trial of adult stem cells in heart attack patients begins Public / Patient: 5 1 rating Health Professionals: 0 0 ratings The largest ever trial of adult stem cell therapy in heart attack patients has begun at The London Chest Hospital in the UK. Heart disease is the world's leading cause of death. Globally, more than 17 million people died from heart disease last year. In the US, over 1 million people suffer a heart attack each year, and about half of them die. Heart attacks are usually caused by a clot in the coronary artery, which stops the supply of blood and oxygen to the heart. If the blockage is not treated within a few hours, then it causes the heart muscle to die. The stem cell trial - titled "The effect of intracoronary reinfusion of bone marrow-derived mononuclear cells (BM-MNC) on allcause mortality in acute myocardial infarction," or "BAMI" for short - has been made possible due to a 5.9 million ($8.1 million) award from the European Commission. The full study involves 19 partners across France, Germany, Italy, Finland, Denmark, Spain, Belgium, Poland, the Czech Republic and the UK. Read the original post: … Continue reading →

Supporters of Californias multibillion-dollar stem cell program plan to ask for $5 billion more to bring the fruits of research to patients. Robert Klein, a leader of the 2004 initiative campaign that established the program, said Thursday hes going to be talking with California voters about the proposal. If the public seems receptive, backers will work to get an initiative on the 2016 ballot to extend funding for the California Institute for Regenerative Medicine Klein outlined the proposal Thursday at UC San Diego Moores Cancer Center, during a symposium on how to speed research to patient care. Since cancer cells and stem cells share some underlying characteristics, CIRM has funded research into those similarities, including the work of Moores Cancer Center researchers David Cheresh and Catriona Jamieson. Klein said supporters, including researchers, patients and patient advocates need to educate the public about the benefits of funding stem cell research, and the results to date. A former chairman of CIRM, Klein is no longer formally affiliated with the agency but continues to support its work. No stem cell treatments funded by CIRM have been approved, but patients have benefited in other ways. CIRM-funded research into cancer stem cells led to a … Continue reading →

Supporters of Californias multibillion-dollar stem cell program plan to ask for $5 billion more to bring the fruits of research to patients. Robert Klein, a leader of the 2004 initiative campaign that established the program, said Thursday hes going to be talking with California voters about the proposal. If the public seems receptive, backers will work to get an initiative on the 2016 ballot to extend funding for the California Institute for Regenerative Medicine Klein outlined the proposal Thursday at UC San Diego Moores Cancer Center, during a symposium on how to speed research to patient care. Since cancer cells and stem cells share some underlying characteristics, CIRM has funded research into those similarities, including the work of Moores Cancer Center researchers David Cheresh and Catriona Jamieson. Klein said supporters, including researchers, patients and patient advocates need to educate the public about the benefits of funding stem cell research, and the results to date. A former chairman of CIRM, Klein is no longer formally affiliated with the agency but continues to support its work. No stem cell treatments funded by CIRM have been approved, but patients have benefited in other ways. CIRM-funded research into cancer stem cells led to a … Continue reading →

San Diego, CA (PRWEB) February 18, 2014 Stemedica Cell Technologies, Inc., a leading manufacturer of adult allogeneic stem cells and stem cell factors, announced today that the company has been issued Patent No. US 8,642,286 B2 entitled, Methods for Identifying Neuripotent Cells by the United States Patent and Trademark Office. The Stemedica patent broadly covers a method for identifying the potency of a cell population, as it becomes neural cells, to engraft in the developing brain of a chick embryo. "This test contributes significantly to the screening of cells capable of engrafting and differentiating in vivo saving both time and valuable resources," said Alex Kharazi, MD, PhD, Chief Technology Officer at Stemedica. "It is a simple, cost-effective test of neural stem cell potency using a chicken embryonic brain, and is an important and effective step forward in the evaluation and testing of neuripotent cells." The chick embryo brain approximates an adult brain. The patented transplant method distinguishes neuripotent stem cells from those which fail to engraft and differentiate into neurons. The method is used for identifying chemical and genetic factors in the manufacture of efficacious neural stem cells. "In vitro propagated neural stem cells have shown great promise in treating … Continue reading →