Category Archives: Stem Cell Human Trials

ALAMEDA, Calif. & JERUSALEM--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) and its subsidiary Cell Cure Neurosciences Ltd. (Cell Cure) today announced that Cell Cure has been awarded a grant for 2012 of 5.04 million Shekels (approximately $1.33 million) from Israels Office of the Chief Scientist (OCS) to help finance the development of OpRegen, a cell-based therapeutic product in development by Cell Cure for the treatment of age-related macular degeneration. Cell Cures plans for the development of OpRegen include filing an application to commence human clinical trials in 2013. We wish to thank the Office of the Chief Scientist for their participation in advancing this important new application of regenerative medicine, said Charles Irving, PhD, Chief Executive of Cell Cure. The dry form of age-related macular degeneration is estimated to afflict over 7.3 million people in the United States alone. We anticipate that OpRegen will make a real difference in the quality of life of the aging population in many industrialized countries, and hence it is a strategic investment for not only Israel, but the world as a whole. Age-related macular degeneration is a severe form of acute vision loss and the leading cause of blindness in an aging population. It … Continue reading →

Human Stem Cells Found to Restore Memory StemCells Inc. hopes a clinical trial of its proprietary stem cells in rodents will lead to a clinical trial with Alzheimer's patients. Neurosphere: StemCells is testing neuronal stem cells, which form floating aggregates when grown in culture, as a treatment for Alzheimers disease, spinal cord injury, and other neurological conditions. StemCells Inc. Last week, a California biotech company announced that its human stem cells restored memory in rodents bred to have an Alzheimer's-like conditionthe first evidence that human neural stem cells can improve memory. The company, called StemCells, is betting that its proprietary preparation of stem cells from fetal brain tissue will take on many different roles in the central nervous system. The company and its collaborators have already shown that its stem-cell product has potential in protecting vision in diseased eyes, acting as brain support cells, or improving walking ability in rodents with spinal cord injury. This metamorphic ability is not so surprisingthey are stem cells, after all. But experts say the quality of scientists involved in StemCells and the interesting properties of its cells sets the company apart. "They've really been steadfast in their work to get these cells into clinical … Continue reading →

Connie K. Ho for redOrbit.com Your Universe Online 20,000,000. This is the number of peripheral artery disease patients Pluristem Therapeutics, a placenta-based cell therapy company, is working to assist. The company recently released information regarding the effectiveness of cell therapy with intramuscular delivery. To begin, Pluristem uses stem cells from the human placenta and has created a manufacturing process that produces enough cells to treat 10,000 patients from one placenta. You usually have to match cells to donors so they do not react. Placental cells are unique because they come from a unique section that combines the mother and the baby. They can be injected without no question age or sex, remarked Zami Aberman, Chairman and CEO of Pluristem. PLacental eXpanded, otherwise known as PLX, cells release a mix of therapeutic proteins to target local and systemic inflammatory diseases. The cells are developed with 3D micro-environmental technology that doesnt require tissue matching before administration. Unlike other cell therapies that are conducted with intravenous injections, the Pluristem treatment includes intramuscular injections that are injected with a needle into the muscle. The cells are grown in 3D and not in human. With [this] technology we give them more natural place, grown in … Continue reading →

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESSWIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502, Takeda) and Millennium: The Takeda Oncology Company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for conditional approval of brentuximab vedotin for two indications: (1) the treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. The CHMP opinion is based on data from clinical trials and other supportive data in relapsed or refractory HL and relapsed or refractory sALCL. We are very pleased with the CHMP positive recommendation for brentuximab vedotin, said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals. Takeda is dedicated to developing innovative and novel therapeutics that make a real difference to patients lives. If approved, brentuximab vedotin will be the third product in the Takeda … Continue reading →

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESSWIRE)-- Millennium: The Takeda Oncology Company and, Takeda Pharmaceutical Company Limited (TSE:4502, Takeda) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for conditional approval of brentuximab vedotin for two indications: (1) the treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL. The CHMP opinion is based on data from clinical trials and other supportive data in relapsed or refractory HL and relapsed or refractory sALCL. We are very pleased with the CHMP positive recommendation for brentuximab vedotin, said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals. Takeda is dedicated to developing innovative and novel therapeutics that make a real difference to patients lives. If approved, brentuximab vedotin will be the third product in the Takeda … Continue reading →

ScienceDaily (July 17, 2012) Using adult stem cells, Johns Hopkins researchers and a consortium of colleagues nationwide say they have generated the type of human neuron specifically damaged by Parkinson's disease (PD) and used various drugs to stop the damage. Their experiments on cells in the laboratory, reported in the July 4 issue of the journal Science Translational Medicine, could speed the search for new drugs to treat the incurable neurodegenerative disease, but also, they say, may lead them back to better ways of using medications that previously failed in clinical trials. "Our study suggests that some failed drugs should actually work if they were used earlier, and especially if we could diagnose PD before tremors and other symptoms first appear," says one of the study's leaders, Ted M. Dawson, M.D., Ph.D., a professor of neurology at the Johns Hopkins University School of Medicine. Dawson and his colleagues, working as part of a National Institute of Neurological Disorders and Stroke consortium, created three lines of induced pluripotent stem (iPS) cells derived from the skin cells of adults with PD. Two of the cell lines had the mutated LRKK2 gene, a hallmark of the most common genetic cause of PD. Induced … Continue reading →

NEWARK, Calif., July 17, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM), today announced preclinical data demonstrating that its proprietary human neural stem cells restored memory and enhanced synaptic function in two animal models relevant to Alzheimer's disease (AD). The data was presented today at the Alzheimer's Association International Conference 2012 in Vancouver, Canada. The study results showed that transplanting the cells into a specific region of the brain, the hippocampus, statistically increased memory in two different animal models. The hippocampus is critically important to the control of memory and is severely impacted by the pathology of AD. Specifically, hippocampal synaptic density is reduced in AD and correlates with memory loss. The researchers observed increased synaptic density and improved memory post transplantation. Importantly, these results did not require reduction in beta amyloid or tau that accumulate in the brains of patients with AD and account for the pathological hallmarks of the disease. The research was conducted in collaboration with a world-renowned leader in AD, Frank LaFerla, Ph.D., Director of the University of California, Irvine (UCI) Institute for Memory Impairments and Neurological Disorders (UCI MIND), and Chancellor's Professor, Neurobiology and Behavior in the School of Biological Sciences at UCI. Matthew Blurton-Jones, Ph.D., … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT:BTX) announced today that Chief Executive Officer Michael D. West, Ph.D. will present at the 2012 Agora Financial Investment Symposium on Tuesday, July 24, 2012, 4:40 p.m. PDT, at the Fairmont Hotel in Vancouver, British Columbia, Canada. Dr. West will speak on The Stem Cell Revolution: Designing First-in-Class Therapies for Age-Related Degenerative Disease, including an update on product development programs at BioTime and its subsidiaries. Dr. Wests presentation will be available online at http://www.biotimeinc.com. The annual symposium held July 24-27 will be the thirteenth for Agora Financial, LLC, an independent firm providing economic forecasting and financial research for over twenty-five years. The Company also announced that the corporate presentation given by Dr. West at the BioTime Annual Meeting of Shareholders held at the Harvard Club of New York City on June 26, 2012 is now available for viewing on BioTime's website under the BioTime 2012 Annual Shareholder Meeting link on the homepage at http://www.biotimeinc.com. The annual corporate presentation provides an update on the technology and business activities of BioTime and its subsidiaries. About BioTime, Inc. BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its … Continue reading →

Australian scientist Prof Alan Trounson is working on a cure for HIV using stem cells. Source: AP A WORLD-renowned Australian stem cell expert working on a cure for HIV says their research is about to progress to human trials. Professor Alan Trounson heads the California Institute of Regenerative Medicine, which is advancing towards a cure for conditions including HIV and diabetes. Prof Trounson, the former director of Monash Immunology and Stem Cell Laboratories in Melbourne, said the research institute's work towards a HIV cure was about to enter human trials. He said if the trials were successful further research would be needed to modify the technology so it could be affordably used where it is needed most, in Africa. "I want the HIV work to go globally because it shouldn't be restricted to patients in Western (countries)," Prof Trounson said. "We're going to have to modify some of that further research to get it into a suitable treatment that we can use in Africa. "I'm very hopeful that the industry will do that. "We have to try and make these as available to people as possible." Prof Trounson said the HIV research uses blood stem cells to mimic a gene … Continue reading →

NEWARK, NJ and SEATTLE, WA--(Marketwire -07/11/12)- Actinium Pharmaceuticals, Inc. ("API", web site, http://www.actiniumpharmaceuticals.com) and Fred Hutchinson Cancer Research Center announced today that they have signed an exclusive worldwide license agreement for BC8, an investigational monoclonal antibody developed to target and eradicate cancerous and other white blood cells in preparation for a hematopoietic stem cell transplantation. BC8, developed by the Hutchinson Center, delivers radioactive isotopes directly to the target cells in order to avoid effects of radiation on most healthy tissues. Under the terms of the license, Actinium Pharmaceuticals has worldwide rights to develop and commercialize BC8. The Hutchinson Center will receive milestone payments and research support funding. Upon commercialization, the Hutchinson Center will also receive royalties on product sales. Hematopoietic stem cell transplantation (HSCT) is the fastest growing hospital procedure in the U.S. Between 2004 and 2007, the most recent available data, procedure related hospital stays grew 51.3 percent, according to the U.S. Government Agency for Healthcare Research and Quality. "Even though most patients with blood cancers are commonly older than 50, currently available preparatory regimens for HSCT, the only potentially curative procedure for many patients, may be intolerable or completely ineffective for those patients. By using BC8 to deliver … Continue reading →