Category Archives: Stem Cell Human Trials

KUALA LUMPUR (Oct 29): The Health Ministry has no intention of introducing a Stem Cell Act as the current guidelines are believed to be sufficient to regulate the research being carried out in this growing field. Minister Datuk Seri Liow Tiong Lai said his ministry has taken the lead to regulate this field by producing four guidelines that provide framework for researchers, clinicians and companies involved in research, clinical trials as well as manufacturing of stem cells. These four guidelines and standards cover haemopoietic stem cell therapy; cord blood banking and transplantation; stem cell transplantation; and stem cell research and therapy. Liow stressed that these guidelines, which were introduced in December 2006, with a second edition in July 2009, serve as standards to which practitioners and scientists must abide to in order to ensure no harm is done to the patient. As such, he said there was no need to table a Stem Cell Bill in Parliament to monitor research and transplants in this field. Liow said the ministry set up a National Sub-Committee for Ethics in Stem Cell Research and Therapy (NSCERT) as an oversight body for all stem cell research in the country, and religious authorities were consulted … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fifth patient, the second in the second patient cohort, in its U.S. clinical trial for Stargardts Macular Dystrophy (SMD). The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells, as compared with the 50,000 cell dose used in the three patients of the first cohort. The patient successfully underwent the outpatient transplantation surgery yesterday, and is recovering uneventfully. We continue to make steady progress in our ongoing clinical trials, commented Gary Rabin, chairman and CEO. We look forward to completing the third and final patient in this cohort in the U.S. clinical trial for SMD in the near future, which will mark the halfway point. We have now mapped out the series of patients to complete this cohort and the second cohort in the European trial, and have done the same in the US AMD trial, pending DSMB review. With all four trial centers in the US and both trial centers in the UK now trained and ready to treat patients, combined with the streamlined process in the European trial protocol, we … Continue reading →

By Jake King Geron Corp (GERN) may have finally found a buyer for its suspended stem cell program. The company has been searching since November of 2011 when Geron halted the projects to focus on the development of Imetelstat and GRN-1005, both cancer treatments. BioTime (BTX) has offered to combine some of its own stem cell assets with those of Geron - plus stock in two BTX subsidiaries - in a new, publicly traded company, BioTime Acquisition Corp (BAC). Through the transaction, GERN shareholders will be given a 21.4% stake in the new company (aggregate); subscription rights to purchase additional stock in BAC, potentially increasing aggregate ownership to 45%; $13M (current value) in BTX warrants; and additional BAC warrants as part of the subscription rights. Already the market likes the looks of the deal, and GERN is up 7% in the early afternoon. Through the transaction, GERN shareholders have the opportunity to continue investing in GERN`s human embryonic stem cell treatments, which many are calling the future of biotech. Divesting of the stem cell program has been a high priority for GERN, and management expected it to generate capital for the company; the all-stock transaction offered by BioTime, however, will … Continue reading →

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug. In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA. "Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday. The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests. The new warning letter reiterates those problems and asks for more information about them. David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA. In a … Continue reading →

WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM). "There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner. Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for … Continue reading →

Substantial improvement of balance sheet and added growth capital positions company to capitalize on commercial opportunities. Atlanta, GA (PRWEB) October 17, 2012 In the companys news yesterday, VistaGen Therapeutics announced the completion of the previously announced $3.25 million financing commitment with Platinum Long Term Growth VII, LLC (Platinum) and approximately $3.0 million strategic debt restructuring. The combined transactions involve the companys three largest institutional shareholders and its patent counsel. Today marks a significant turning point for VistaGen. These transactions represent a tremendous vote of confidence by four of our major stakeholders and position us to realize the full measure of our commercial opportunities involving our stem cell technology platform and AV-101 clinical program, stated Shawn K. Singh, VistaGens Chief Executive Officer. Our expectations are set very high. Over the next 12 months, we plan to achieve multiple transformative milestones, both in the lab and in the clinic. This funding provided by Platinum, combined with our strategic equity-based restructuring transactions with Cato Research, Morrison & Foerster and University Health Network, will be instrumental in our success, concluded Mr. Singh. Allen Cato, M.D., Ph.D., co-founder and Chief Executive Officer of Cato Research, commented, By more closely approximating human biology, VistaGens stem cell-based … Continue reading →

SOUTH SAN FRANCISCO, CA--(Marketwire - Oct 16, 2012) - VistaGen Therapeutics, Inc. ( OTCBB : VSTA ) ( OTCQB : VSTA ), a biotechnology company applying stem cell technology for drug rescue and novel pharmaceutical assays for predictive heart and liver toxicology and drug metabolism screening, today announced the completion of the previously announced $3.25 million financing commitment with Platinum Long Term Growth VII, LLC (Platinum) and approximately $3.0 million strategic debt restructuring. The combined transactions involve the Company's three largest institutional shareholders and its patent counsel. "Today marks a significant turning point for VistaGen. These transactions represent a tremendous vote of confidence by four of our major stakeholders and position us to realize the full measure of our commercial opportunities involving our stem cell technology platform and AV-101 clinical program," said Shawn K. Singh, VistaGen's Chief Executive Officer. "Our expectations are set very high. Over the next 12 months, we plan to achieve multiple transformative milestones, both in the lab and in the clinic. This funding provided by Platinum, combined with our strategic equity-based restructuring transactions with Cato Research, Morrison & Foerster and University Health Network, will be instrumental in our success," concluded Mr. Singh. Allen Cato, M.D., Ph.D., … Continue reading →

AUSTIN, Texas, Oct. 12th, 2012 /PRNewswire-USNewswire/ -- Prominent stem cell scientists, physicians, and advocates from leading medical facilities and research institutions across Texas and California will highlight the 3rd Annual Stem Cell Research Symposium: Spotlight on Texas, on October 19, 2012, at the Texas State Capitol. This free, public symposium, produced and co-hosted by the Austin-based nonprofit Texas Cures Education Foundation (Texas Cures), is designed to educate the public about the exciting stem cell research andclinical trials currently under way in Texas.The event will also include a discussion of recent Texas laws affecting stem cell research, the potential economic impact of stem cell research and highlight the current progress in one of the most promising areas of medicine. This year, more than a dozen local and national advocacy groups, institutions and foundations showed their support for the efforts of the hosting organizations Texas Cures and Texans for Stem Cell Research including the Genetics Policy Institute, Alliance for Regenerative Medicine and Texans for Advancement of Medical Research. The symposium begins at 8:30 a.m. in the Capitol Extension Auditorium (E1.004), located at the Texas State Capitol Building. Admission is free and open to the public.Registration is recommended. This program unites the diverse … Continue reading →

Friday, Oct. 12, 2012 Stem cells derived from a mouse's skin won Shinya Yamanaka the Nobel Prize in physiology or medicine on Monday. Now researchers in Japan are seeking to use his pioneering technology for an even greater prize: restoring sight. Scientists at the Riken Center for Developmental Biology in Kobe plan to use induced pluripotent stem (iPS) cells in a human trial using patients with macular degeneration, a disease in which the retina becomes damaged and results in loss of vision, Yamanaka, a Kyoto University professor, told reporters the same day in San Francisco. Companies including Pfizer Inc. are already planning trials of stem cells derived from human embryos, but Riken's will be the first to use a technology that mimics the power of embryonic cells while avoiding the ethical controversy that accompanies them. "The work in that area looks very encouraging," John B. Gurdon, 79, a professor at the University of Cambridge who shared this year's Nobel Prize with Yamanaka, said in an interview in London. Yamanaka and Gurdon split the 8 million Swedish kronor (about 94 million) award for experiments 50 years apart demonstrating that mature cells in latent form retain all of the DNA they had … Continue reading →

About health & biology Stem cells can develop into many different kinds of cells as living things grow & promise new ways to cure disease. Photo shows how stem cells differentiate to form the cells of different organs in the body such as the heart and brain (Source: Wikipedia) The science book The Epigenetics Revolution (2011) explains the Nobel Prize-winning stem cells discoveries in greater detail. Click button to listen to Nobel Prize for Stem Cell Research download By Pia Ohlin (AFP) STOCKHOLM Shinya Yamanaka of Japan and John Gurdon of Britain won the Nobel Prize for work in cell programming, a frontier that has nourished dreams of replacement tissue for people crippled by disease. Their findings have revolutionised our understanding of how cells and organisms develop .... By reprogramming human cells, scientists have created new opportunities to study diseases and develop methods for diagnosis and therapy" [the Nobel jury declared on Monday]... Stem cells are precursor cells which differentiate into the various organs of the body. They have stirred huge excitement, with hopes that they can be coaxed into growing into replacement tissue for victims of Alzheimer's, Parkinson's and other diseases... See original here: Nobel prize for medicine: Stem … Continue reading →