Category Archives: Stem Cell Human Trials

Business | Events | Policy | People | Research | Trend watch Database case The American Chemical Society (ACS), the worlds largest scientific society, is likely to have to pay US$11.5million in compensation to a small start-up company after a ruling by the Ohio Supreme Court on 18September. The court ruled that the ACS, based in Washington DC, filed a lawsuit to unfairly suppress chemical-informatics firm Leadscope of Columbus, Ohio. See page482 for more. Drug-makers unite Ten giant pharmaceutical companies have formed a non-profit organization called TransCelerate BioPharma, with the goal of making clinical trials more efficient. By setting universal standards in trial design and data collection, the group could shave time and expense off the drug-development process, says Garry Neil, head of TransCelerate and a former vice-president of science and technology at Johnson & Johnson. Smaller companies are invited to join the team. See go.nature.com/jj2sky for more. Dark Energy Survey Collaboration/FERMILAB First light for dark-energy lens A camera designed to hunt for signs of dark energy, a force thought to be responsible for the Universes rapid expansion, snapped its first images on 12September. The images from the Dark Energy Survey camera (Nature 489, 190191; 2012), which is mounted on … Continue reading →

ROCKVILLE, Md., Sept. 24, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that President and CEO Richard Garr will present at the 2012 Aegis Healthcare Conference on Friday, September 28 at 10:00 a.m. PT. Garr will discuss the company's opportunities in neural stem cell therapy and neurogenic drugs. He will provide an update on the company's ongoing clinical trials: NSI-566/amyotrophic lateral sclerosis (ALS) and NSI-189/major depressive disorder, and an overview on future trials. (Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO ) About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem has recently completed an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA. In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety … Continue reading →

Biotechs are causing a stir. Photo: James Davies Prana Biotech, which is researching a cure for Alzheimer's disease and the better known stem cell therapy researcher Mesoblast are two companies that are definitely in the sweet spot when it comes to investor hopes. At 26 cents Prana Biotechnology (PBT) has climbed almost 60 per cent in the past month in the wake of a bullish report by its house broker in New York, MLV & Co and its analyst Dr George Zavoico about its drug PBT2. The company alerted the ASX to this report yesterday. Its market cap is only $81 million, but the Victorian-based Prana's claims that it is world leading in neurodegenerative diseases could actually be true in the wake of the recent high-profile failures last month by industry giants Pfizer, Johnson & Johnson and Eli Lilly. Pfizer alone has spent about $1.6 billion on research and development on Alzheimer's, which affects one in 200 people and has the effect of causing early dementia and memory loss. The industry giants were all in the last stages of clinical trial programs, so the outcomes were particularly galling for sufferers as they were failures among many. Advertisement Prana has only … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) announced that Chief Executive Officer Michael D. West, Ph.D. will present at the Stem Cells USA & Regenerative Medicine Congress 2012 in Cambridge, MA on Thursday, September 20, 2012. Dr. West will speak on Second Generation hES Cell-Based Therapies: Achieving Purity and Scalability in the Midst of Diversity in the session Developments in Novel Therapeutics. The presentation will be made available on BioTime's website at http://www.biotimeinc.com. The Stem Cells USA & Regenerative Medicine Congress 2012, September 20-21, is North Americas leading commercial stem cell event. This years conference will focus on strategies and business models for navigating the stem cell and regenerative medicine marketplace for pharma, biotech, and investors. About BioTime, Inc. BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, HyStem hydrogels, culture media, and differentiation kits. BioTime is developing Renevia (formerly known as HyStem-Rx), a biocompatible, implantable hyaluronan and collagen-based … Continue reading →

When a Swiss-based researcher announced this month he had achieved some improvement in profoundly paralyzed spinal-cord-injury patients with an injection of stem cells, he generated headlines worldwide. Dr. Armin Curts findings were the first evidence from actual humans though far from conclusive that the much-hyped stem-cell concept might work in paraplegic and quadriplegic patients. What went unsaid was that the breakthrough could have taken place in Canada. Dr. Curt, then working in Vancouver, and Dr. Michael Fehlings, a Toronto-based leader in the field, had earlier proposed that the clinical trial be conducted here. Federal regulators, however, are essentially standing in the way of studying stem-cell treatments on spinal-cord patients, insisting that promising results achieved in rats and mice be first replicated in monkeys or apes, the two researchers say. Such non-human primate studies would be extraordinarily costly, highly time-consuming and ethically challenging, said Dr. Fehlings, medical director of the Krembil Neuroscience Centre at Toronto Western Hospital. And he said little would be gained by conducting them. It probably would have delayed the field by another 10 years, said the neurosurgeon. When you think about a condition as serious and life-threatening and damaging as spinal cord injury is that a reasonable … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT) (ACTC), a leader in the field of regenerative medicine, announced today that director of business development, Matthew Vincent, Ph.D., will be presenting at Terrapinns Stem Cells USA and Regenerative Medicine Congress, September 20-21 in Boston. Dr. Vincents presentation, Advancing stem cell therapies to the clinic: ACT's three cellular therapy programs, will be given on Thursday, Sept. 20 at 3:15 p.m. EDT. Dr. Vincent will discuss the meaning and significance of the results seen thus far in ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD). About SMD, Dry AMD and Degenerative Diseases of the Retina Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer. Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the … Continue reading →

GAITHERSBURG, Md., Sept. 17, 2012 /PRNewswire/ -- Cytomedix, Inc. (CMXI), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that its common shares are now trading on the highest OTC marketplace, OTCQX, under the ticker symbol "CMXI." Cytomedix upgraded from OTCQB today to trade on the OTC market's prestigious marketplace, OTCQX. Investors can find current financial disclosure and real-time Level 2 quotes for the Company's common shares at http://www.otcmarkets.com. "We believe investors will appreciate the quality-controlled admission process, the transparent trading and easy access to company information that are hallmarks of the OTCQX," said Martin P. Rosendale, Chief Executive Officer of Cytomedix. C. K. Cooper & Company will serve as Cytomedix's Designated Advisor for Disclosure ("DAD") on OTCQX, and will be responsible for providing guidance on OTCQX requirements. About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. The Company's … Continue reading →

Embryonic stem cells have been dubbed "the sleeper issue" of the 2012 election, but stem-cell research (taking cells from human embryos to create new cells that can treat disease) has long been a hot-button topic. The problem is that embryos traditionally are destroyed to extract the cells--something that plenty of people are uncomfortable with. But if there was a way to extract human embyronic stem cells without destroying anything, well, that shouldnt create any ethical quandaries. Advanced Cell Technology, a biotechnology company specializing in cellular therapies, thinks it has the solution. ACT uses an embryonic stem-cell-removal technique that doesnt destroy anything: It removes a single cell from embryos that are in the eight-cell stage--in other words, extremely early on. Its identical to whats done in in-vitro fertilization clinic for genetic testing of diseases like Tay-Sachs and Huntingtons Disease. "Its a non-destructive, non-harmful method of extracting these cells and creating embryonic stem cells. There are thousands of babies born every year having this exact kind of genetic testing done," says ACT CEO Gary Rabin. The cells propagate infinitely, so once you have what you need, you never have to go back to an in-vitro fertilization clinic to get more. ACT hasnt … Continue reading →

LONDON (Reuters) - Scientists have restored hearing to deaf gerbils using human embryonic stem cells in an advance that could eventually help people with an intractable form of deafness caused by nerve damage. The procedure needs further animal research to assess safety and long-term effectiveness but researchers said on Wednesday the experiment was an important proof of concept, marking a further advance in the growing field of regenerative medicine. Marcelo Rivolta from Britain's University of Sheffield, who led the research, said the first patients could receive cell therapy for hearing loss in clinical trials in "a few years." After treating 18 gerbils with complete deafness in one ear, his team reported in the journal Nature that stem cells produced an average 46 percent recovery in hearing function, as measured by electrical signals in the animals' brains. "If this was a human patient, it would mean going from being so deaf as to be unable to hear a lorry or truck on the street to being able to maintain a conversation," Rivolta told reporters. "What we have shown here is functional recovery using human stem cells, which is unique." Gerbils were selected for the test because their hearing range is similar … Continue reading →

TORONTO - Researchers have restored the ability to hear in deaf gerbils using implanted human stem cells, achieving what they call a first step in potentially overcoming some causes of hearing loss in people. While more study is needed to ensure the technique is safe for humans, principal researcher Dr. Marcelo Rivolta of the University of Sheffield said the work shows that stem cells can indeed regenerate nerve cells needed for hearing. "It is early days, but we believe this is a substantial step forward because what we have here is the proof of concept that we can use human stem cells derived from human embryonic stem cells to repair the ear," Rivolta said from Sheffield, England. The researchers, who describe their work in a paper published Wednesday in the journal Nature, began by using a chemical to destroy inner-ear mechanisms to render the gerbils deaf. Gerbils, long-tailed rodents that range in length from 15 to 30 centimetres and live three to four years, have hearing that more closely approximates that of humans, compared with laboratory rats or mice. Rivolta's team manipulated human embryonic stem cells taken from a cell line approved for use in research to create "otic progenitor" … Continue reading →