Category Archives: Stem Cell Human Trials

CHICAGO and SAN DIEGO, Nov. 12, 2012 /PRNewswire/ -- HumanZyme and PacificGMP today announced a partnership to manufacture clinical grade, authentic human growth factors and cytokines. The companies will make available for the first time, a safe and authentic source of these proteins to regenerative medicine developers to change stem cells into differentiated cell types that will be used to treat various diseases or injuries. The partnership combines HumanZyme's HumanKineTM growth factors and cytokines with PacificGMP's extensive experience and expertise in manufacturing GMP-certified recombinant human proteins intended for human clinical use. Growth factors and cytokines, which are proteins, provide researchers a means to convert stem cells into specific cell types such as heart cells or neurons. Previous stem cell research is now being translated from the laboratory to regenerative medicine therapies to repair damaged cells from traumatic injuries such as heart attacks or to restore cellular functions that have been lost or are missing in diseases such as diabetes and Parkinson's Disease. While growth factors and cytokines are already available to stem cell researchers, the regenerative medicine community currently lacks access to many clinical grade growth factors and cytokines that are needed to ensure that human cellular therapy trials are … Continue reading →

SOURCE: VistaGen Therapeutics, Inc. Novel Human Stem Cell-Based Bioassay Based on VistaGen's Human Clinical Trials in a Test Tube Platform SOUTH SAN FRANCISCO, CA--(Marketwire - Nov 13, 2012) - VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism screening, today announced a significant advance in its development of LiverSafe 3D, a human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism issues in connection with the Company's drug rescue activities. Shawn K. Singh, VistaGen's Chief Executive Officer, stated, "As we have done with CardioSafe 3D, our stem cell-based bioassay system for predictive heart toxicity screening and drug rescue, we are developing LiverSafe 3D to change the game in drug development -- to generate clinically predictive liver toxicology and liver metabolism data at the front end of the drug development process, long before standard animal and human testing." VistaGen's LiverSafe 3D, together with optimized culture protocols and without the need for any purification, is now capable of producing differentiated populations of cells containing greater than 70% albumin-positive human hepatocytes (liver cells), and greater than 40% of these hepatocytes express the mature CYP3A4 drug metabolizing enzyme. … Continue reading →

By Philip C. Tubeza Philippine Daily Inquirer The Department of Health (DOH) on Saturday warned those contemplating stem cell therapy against using stem cells from aborted babies and human embryos. The DOH issued the statement as it reviewed the legal and technical specifications of stem cell therapy to come up with a regulatory framework. The Philippine government will not allow the use of aborted fetuses or human embryos (as sources of stem cells). There is a need to ensure that the biological raw materials are documented and validated and follow infection-free procedures, the health department said. There is also a need to know if the materials to be injected came from animal or human tissues, it added. The DOH said the other fundamental areas of the regulatory framework would include the monitoring of the marketing claims by medical centers that offer stem cell therapy so that the claims stick within the boundaries of science as objectively as possible. Credentials and procedures The credentials of the scientists involved should also match the training, education and skills required for these procedures while good laboratory procedures should be observed in the preparation of the tissue and cells, the DOH said. The centers to … Continue reading →

There's no room for X-Men, Spiderman or Avengers Assemble on our definitive list of flicks inspired by graphic novels A LEADING stem cell research firm yesterday said it had halted human trials on spinal cord injuries like those suffered by Superman actor Christopher Reeve. FROM hurling themselves off bridges and leaping from burning vehicles to smashing up cars doing death-defying stunts. Barack Obama yesterday overturned a funding ban on stem cell research in a bid to make America a trail-blazer in finding cures for illnesses such as Alzheimer's disease. What does a mother do when the child she can remember singing to sleep, whose scraped knees she bandaged and who she loves more than life itself, begs: "Mum, help me to die?" What does a mother do when the child she can remember singing to sleep, whose scraped knees she bandaged and who she loves more than life itself, begs: "Mum, help me to die?" What does a mother do when the child she can remember singing to sleep, whose scraped knees she bandaged and who she loves more than life itself, begs: "Mum, help me to die?" George Clooney as Batman has been voted the sexiest male superhero of … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that its upcoming conference call on its third quarter financial results will also provide some representative examples of data being collected from patients in its clinical trials for forms of macular degeneration. The Company has treated 13 patients thus far in its three ongoing trials for dry age-related macular degeneration (dry AMD) and Stargardts Disease (SMD) using human embryonic stem cell (hESC)-derived retinal pigment epithelial cells. The first two trials were initiated in July of 2011. The three clinical trials involve four of the top-ranked eye hospitals in the U.S., and two of the leading eye hospitals in the U.K. Across the various clinical trial sites, with regular patient follow-up, no adverse safety issues relating to the transplanted cells have been observed. At up to 16 months following treatment, no hyperproliferation, tumorigenicity, ectopic tissue formation, or apparent rejection were observed in any of the 13 patients at any time. Detailed clinical and diagnostic laboratory assessments were performed at multiple post-transplantation evaluations. In addition to monitoring the safety of the transplanted cells, the clinicians have also been carefully assessing patients on … Continue reading →

Presentation illuminated the important synergistic interactions of VistaGens stem cell-derived human cardiomyocytes (heart cells) and Dukes tissue engineering and analytical technologies. Atlanta, GA (PRWEB) November 09, 2012 In the companys news yesterday, VistaGen Therapeutics announced that results of their collaboration with Duke University were presented this week at the American Heart Association 2012 Scientific Sessions in Los Angeles. The presentation, entitled Human embryonic stem cell-derived cardiac tissue patch with advanced structure and function, illuminated the important synergistic interactions of VistaGens stem cell-derived human cardiomyocytes (heart cells) and Dukes tissue engineering and analytical technologies. The research, which expands the scope of VistaGens drug rescue capabilities focused on heart toxicology, was led at Duke by Dr. Nenad Bursac, Associate Professor in the Departments of Biomedical Engineering and Cardiology, and at VistaGen by Dr. Ralph Snodgrass, President and Chief Scientific Officer. The high-quality and purity of VistaGens cardiomyocytes, together with Dr. Bursacs innovative tissue engineering technologies, enabled the development of novel methods of engineering three-dimensional (3D) cardiac tissues and unique in vitro systems for studying the maturation and electromechanical function of human cardiac muscle. These technologies provide novel in vitro tools for evaluating drug effects, positive and negative, on human cardiac tissues. I … Continue reading →

ALAMEDA, Calif. & JERUSALEM--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) and its subsidiary Cell Cure Neurosciences Ltd. (Cell Cure) today announced that they have entered into a share purchase agreement through which BioTime agreed to purchase 87,456 Cell Cure ordinary shares in exchange for 906,735 BioTime common shares. As a result of the share purchase, BioTime will own, directly and through its wholly owned subsidiary ES Cell International Pte. Ltd., approximately 62.6% of the outstanding ordinary shares of Cell Cure. The number of BioTime common shares that will be issued to acquire the Cell Cure shares was based upon an average market price of $3.86 per BioTime common share determined on the basis of the ten actual trading days prior to November 1, 2012. Under the Share Purchase Agreement, BioTime may be required to issue additional common shares to Cell Cure, or Cell Cure may be required to issue additional Cell Cure ordinary shares to BioTime, depending upon whether the market value of BioTime common shares increases or decreases by more than 15%, based upon the average closing price for the ten trading days commencing on May 1, 2013. If the market value of BioTime common shares declines by more … Continue reading →

By E.J. Mundell HealthDay Reporter TUESDAY, Nov. 6 (HealthDay News) -- Updated two-year results from a small trial using cardiac stem cells to repair damaged hearts suggest the treatment's healing effect persists. Patients with heart failure caused by prior heart attacks who got the treatment continue to see reductions in cardiac scar tissue, improvements in the heart's pumping ability and even a boost in their quality of life, researchers said. These improvements seem to be continuing as time goes on, suggesting that stem cell therapy's healing power hasn't diminished. "Now we need to perform larger and randomized, blinded studies ... to confirm this data," said study lead author Dr. Roberto Bolli, director of the Institute of Molecular Cardiology at the University of Louisville. His team presented its results Tuesday at the American Heart Association's annual meeting, in Los Angeles. According to the AHA, more than 6 million Americans suffer from heart failure, a gradual weakening of the heart often caused by damage from a prior heart attack. Despite its prevalence and lethality, virtually no advance has been made over the past few decades in doctors' ability to treat or reverse heart failure. That's why the advent of stem cell therapy … Continue reading →

SOUTH SAN FRANCISCO, CA--(Marketwire - Nov 7, 2012) - VistaGen Therapeutics, Inc. ( OTCBB : VSTA ) ( OTCQB : VSTA ), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism screening, and Duke University, one of the country's premier academic research institutions, announced that results of their collaboration were presented yesterday at the American Heart Association 2012 Scientific Sessions in Los Angeles. The presentation, entitled "Human embryonic stem cell-derived cardiac tissue patch with advanced structure and function," highlighted the important synergistic interactions of VistaGen's stem cell-derived human cardiomyocytes (heart cells) and Duke's tissue engineering and analytical technologies.The research, which expands the scope of VistaGen's drug rescue capabilities focused on heart toxicology, was led at Duke by Dr. Nenad Bursac, Associate Professor in the Departments of Biomedical Engineering and Cardiology, and at VistaGen by Dr. Ralph Snodgrass, President and Chief Scientific Officer. The high-quality and purity of VistaGen's cardiomyocytes, together with Dr. Bursac's innovative tissue engineering technologies, enabled the development of novel methods of engineering three-dimensional (3D) cardiac tissues and unique in vitro systems for studying the maturation and electromechanical function of human cardiac muscle. These technologies provide novel in vitro tools for evaluating … Continue reading →

TORONTO, ONTARIO--(Marketwire - Nov. 7, 2012) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS), a life sciences company developing stem cell-related technologies, today announced the signing of an agreement with University Health Network ("UHN"), through its commercialization agent MaRS Innovation ("MI"), both of Toronto. The agreement provides Stem Cell Therapeutics ("SCT") with an option to an exclusive world-wide license to an innovative cancer stem cell program. Based on Dr. Aaron Schimmer's award-winning research, the technology has provided compelling evidence that tigecycline, an FDA-approved antibiotic, is able to selectively target leukemia cells and leukemic stem cells by shutting down their energy supply through the inhibition of mitochondrial protein synthesis. Dr. Schimmer, Associate Professor in the University of Toronto's Department of Medical Biophysics and a clinician-scientist in the Princess Margaret Cancer Centre/Ontario Cancer Institute at University Health Network, published his findings in 2011 in the journal Cancer Cell. Based on this discovery, Dr. Schimmer received the 2012 Till & McCulloch Award presented each year by the Stem Cell Network to recognize the year's most influential peer-reviewed article by a researcher in Canada. "In recent years Dr. Schimmer has had a widely-recognized rise to become one of Canada's premier clinician-scientists," commented David Allan, Executive … Continue reading →