Category Archives: Stem Cell Human Trials

NEW YORK- After more than 15 years of failures by scientists around the world and one outright fraud, biologists have finally created human stem cells by the same technique that produced Dolly the cloned sheep in 1996: They transplanted genetic material from an adult cell into an egg whose own DNA had been removed. The result is a harvest of human embryonic stem cells, the seemingly magic cells capable of morphing into any of the 200-plus kinds that make up a person. The feat, reported on Wednesday in the journal Cell, could re-ignite the field of stem-cell medicine, which has been hobbled by technical challenges as well as ethical issues. Until now, the most natural sources of human stem cells have been human embryos, whose use in research poses ethical quandaries. The technique announced on Wednesday, by scientists at Oregon Health & Science University and the Oregon National Primate Research Center, uses unfertilized human eggs. Eliminating the need for human embryos could boost attempts to use stem cells and their progeny to replace cells damaged or destroyed in heart disease, Parkinson's disease, multiple sclerosis, spinal cord injuries and other devastating conditions. But the achievement could also revive fears of reproductive … Continue reading →

Dr. Shoukhrat Mitalipov, Ph.D., researches in the lab at the Oregon Health & Science University. For the first time, a team of scientists say they have successfully converted human skin cells into embryonic stem cells, a move that could help quiet the ethical debate surrounding stem cell research. Researchers at Oregon Health & Science University say they were able to implant the nucleus from a skin cell into a donated human egg cell with its nucleus removed, creating an embryo-like cell that has the genetic makeup of the patient who donated the skin cell. [RELATED: Scientists Can Turn Stem Cells Into Brain Cells] Since 2007, scientists have had successes with the procedure using monkeys and other mammals but not with human subjects. "Every species is a little different biologically," says Shoukrat Mitalipov, lead author of the study, which was published Wednesday in Cell. "We've been using a good model in primates, but we've now finally been able to optimize it in humans." The embryonic stem cells created by Mitalipov can be differentiated into many types of human cell, including nerve cells, liver cells and heart cells. Scientists have suggested that stem cells may one day be used to treat brain … Continue reading →

ALAMEDA, Calif. & JERUSALEM--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) and its subsidiary Cell Cure Neurosciences Ltd. (Cell Cure Neurosciences) today announced that Cell Cure Neurosciences has been awarded a grant of 5.34 million Shekels, approximately $1.5 million, for 2013 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 Neurosciences for the treatment of age-related macular degeneration. Cell Cure Neurosciences plans for the development of OpRegen include completion of preclinical testing and filing an application to commence human clinical trials in 2014. We thank the Israel Office of the Chief Scientist for their continuing support of stem cell research and their participation in advancing this important new application of regenerative medicine, said Charles Irving, PhD, Chief Executive of Cell Cure Neurosciences. The dry form of age-related macular degeneration is one of the leading diseases of aging and 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 baby-boom generation in many industrialized countries, and hence it is a strategic investment for the world as a … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT or the Company; OTCBB: ACTC) a leader in the field of regenerative medicine, announced today its first quarter financial results for the period ended March 31, 2013. The Company reported a loss from operations of $(5.8) million compared to a loss from operations of $(5.4) million in the 2012 first quarter, primarily as a result of higher clinical trial expenses. ACT reported a net loss of $(6.4) million or $(0.00) per share, compared to a loss in the same period in 2012 of $(5.7) million or $(0.00) per share. Net cash used in operations for the 2013 first quarter was $8.3 million, compared to net cash used in operations of $4.8 million during the same period in 2012. The Company ended the 2013 first quarter with cash and cash equivalents of $4.1 million, compared to $7.2 million as of December 31, 2012, primarily due to higher operating expenses. Cash utilization increased significantly as a result of $2.3 million used to settle litigation related to previously issued debentures. The Company expects cash utilization to return to previous levels in the subsequent quarter. Highlights from the first quarter of 2013 included: I am pleased … Continue reading →

NEWARK, Calif., May 9, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today reported financial results for the first quarter ended March 31, 2013 and provided a business update. "In the first quarter, we reported the most recent data from our spinal cord injury trial, which showed that the multi-segmental gains in sensory function observed at the six-month time point in two of three patients had persisted through the twelve-month assessment, and that one of the two had converted from a complete injury to an incomplete injury classification," said Martin McGlynn, President and CEO of StemCells, Inc. "This exciting development follows the publication, last fall, of the data from our Phase I PMD trial showing evidence of new myelin formation on the nerve axons of all four patients in the trial and gains in neurological function in three of the four patients. Our encouraging data to date tells us that we are on the right track, and we are now focused on accelerating enrolment in our ongoing trials. We have taken concrete steps to this end in our spinal … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today reported financial results for the first quarter ended March 31, 2013 and highlighted recent corporate accomplishments. First Quarter and Recent Corporate Accomplishments Financial Results Net Loss Net loss attributable to BioTime, Inc. for the first quarter of 2013 was $7.7 million or $0.15 per share, compared to a net loss of $5.0 million or $0.10 per share for the same period of 2012. Contributing to the increased expenses year-over-year was approximately $1 million in organization, legal, and start up costs associated with Asterias. The other subsidiaries combined for approximately $4 million of other operating losses, with the balance of the operating loss of approximately $3 million residing in BioTime. Historically BioTime's subsidiaries have raised capital, received grants, and generated revenues independently of BioTime to help fund their operations; we expect the subsidiaries to continue to pursue such financing strategies in the future. Revenue Total net revenue, including license fees (which also include online database subscription and advertising revenues), royalties from sales of Hextend, research product sales, and grant income, on a consolidated basis, was $0.4 million in … Continue reading →

LOS ANGELES, CA--(Marketwired - May 8, 2013) - Pluristem (NASDAQ: PSTI) recently announced a new Phase I trial to check safety and evaluate effectiveness of its PLX-PAD cells in chronic tendonitis often leading to rotator cuff disorders, common in tennis players and golfers, where there are roughly 200,000 rotator cuff surgeries done each year in the US alone. Major insurers put the overall cost of rotator cuff operations at $6,700 each, with a lucrative $1,700 in doctor fees, draining our health care system of over $1.3 billion. Although cell therapy is not commonly associated with sports medicine procedures, it's time something new is tried to take down costs of these pricey procedures, something that doesn't involve dangerous devices or daily pill-popping. Stem cell treatments are usually associated with serious diseases like cancer and chronic heart conditions, but have recently taken on the glamour of a potential quick-fix in the world of sports, causing celebrity athletes like Jason Kidd of the NY Knicks or NBA All-Star Allan Houston to seek them out in hopes of fast recoveries and better performance. Ethical considerations were bypassed when it became possible to use adult stem cells from fat, bone marrow or, even better, the … Continue reading →

David Baylink, MD, left, professor of medicine at Loma Linda University, asks a question during the bacterial therapeutics panel discussion at the Cell-Based Therapeutics symposium at UCSF, while Carl June, MD, right, listens. Old-line pharmaceutical companies and maturing biotech businesses both are graybeards compared to newer ventures focused on cell therapy. With cell therapy the drugs are alive. Cells are engineered and reprogrammed outside the body to perform specific tasks and then given as treatment. Cells are like soft robots, said Wendell Lim, PhD, director of the Center for Systems & Synthetic Biology at UC San Francisco and an organizer Cell-Based Therapeutics: The Next Pillar of Medicine, a daylong symposium held at UCSFs Mission Bay campus last month. Lim and other scientists aim to take advantage of the modules that already function within cells, and to manipulate them for specific therapeutic goals sometimes by introducing new functions. We want to build therapeutic cells with precisely controlled activities, Lim said. We want to control how cells proliferate, where they go, how they are activated and how to turn them off or even destroy them when they are no longer needed. Read this article: Cell Therapy Promise Highlighted at UCSF Symposium … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) and subsidiary, LifeMap Sciences, today announced the release of the enhanced LifeMap BioReagents portal (http://bioreagents.lifemapsc.com/) featuring an improved user interface, product descriptions, and customer support options, as well as the addition of new PureStem progenitor cells to the site. These novel progenitors provide new and unique tools for researchers to study developmental biology, tissue genesis and regenerative medicine, demonstrating purity in culture and unique gene expression. Among the new product offerings are novel PureStem progenitor cells such as the E72 cells capable of differentiating into betatrophin-expressing adipocytes, which may be useful in diabetes research. Via LifeMap BioReagents, researchers in academia, research hospitals, and biotech and pharma companies can access and purchase BioTimes research products, including PureStem human progenitor cells, PureStem packages, clinical and research grade human embryonic stem cell (hES) lines, culture media, and cell differentiation kits. As of April, the portal also offers select recombinant proteins, including growth factors, signaling molecules, differentiation factors, cytokines and chemokines that complement BioTimeresearch product lines. LifeMap BioReagents is integrated with LifeMaps integrated database suite products LifeMap Discovery, GeneCards and MalaCards, thereby providing all biomedical researchers accessing these databases a means of identifying stem cell reagents … Continue reading →

HAIFA, Israel, May 7, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that it has identified its first clinical indication in the hematology field for its Placental eXpanded (PLX) RAD cells for the enhancement of the engraftment of Hematopoietic Stem Cells (HSC) in patients experiencing a delay or failure of their bone marrow transplant (BMT). This follows Pluristem's completion of additional pre-clinical studies showing promising results for PLX-RAD for this indication. According to the National Marrow Donor Program, an estimated 25,000 allogeneic bone marrow transplants are performed annually worldwide. Approximately 15% of these patients will either have a delay or failure to engraft the HSCs, resulting in a condition that is life threatening, expensive and often requires the continued support of the patient with blood products. PLX-RAD may be beneficial to these patients. PLX-RAD is currently being evaluated by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), a division of the U.S. National Institutes of Health, in models of the acute radiation syndrome (ARS). PLX-RAD, Pluristem's second product candidate, joins PLX-PAD that is in clinical trials for the treatment of peripheral artery disease, muscle injury and Pulmonary Hypertension. … Continue reading →