Category Archives: Stem Cell Human Trials

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the companys three ongoing clinical trials, has authorized the company to move forward with enrollment and treatment of additional patients in its clinical trial for dry age-related macular degeneration (dry AMD). ACT will proceed with patient screening and enrollment for the second cohort, who, in keeping with trial protocol, will be injected with 100,000 retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs), as compared with the 50,000-cell dose used in the first cohort. DSMB authorization to move to the higher dosage of cells in our clinical trial for dry AMD represents a significant milestone for our clinical programs, commented Gary Rabin, chairman and CEO of ACT. Our RPE program is now advancing rapidly, as we are now screening at multiple ophthalmological centers for the fourth surgery in both our dry AMD trial and our U.S. SMD trial, with our E.U. SMD trial, which was initiated much later, not far behind. The trial is a prospective, open-label study, designed to determine … Continue reading →

NEW YORK, July 9, 2012 (GLOBE NEWSWIRE) -- Dear NeoStem Shareholders, NeoStem (NYSE MKT:NBS) is rapidly emerging as a technology and market leading company in the fast developing cell therapy market. Our multifaceted business strategy combines a state-of-the-art contract development and manufacturing organization (CDMO) with a medically important cell therapy product development program enabling immediate and long-term revenue growth opportunities. Our service business and pipeline of proprietary cell therapy products work in concert, giving NeoStem a competitive advantage that is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a dynamic patent and patent pending (IP) portfolio, NeoStem is well positioned to succeed. We would like to take a moment to update you on the following recent developments and important near term catalysts for the second half of 2012: In April 2012, Jonathan Sackner-Bernstein, MD, FACC joined the Company as Vice President of Clinical Development and Regulatory Affairs. Jonathan brings to the Company over 20 years of experience as a clinical cardiologist and medical researcher with leadership in healthcare management. Jonathan joined the team to advance Amorcyte's PreSERVE AMI Phase 2 trial and to provide regulatory support for NeoStem's product pipeline. His … Continue reading →

Public release date: 6-Jul-2012 [ | E-mail | Share ] Contact: John Wallace wallacej@vcu.edu 804-628-1550 Virginia Commonwealth University Richmond, Va. (July 9, 2012) Researchers at Virginia Commonwealth University (VCU) Massey Cancer Center's Bone Marrow Transplant Program have demonstrated that the use of antibodies derived from rabbits can improve the survival and relapse outcomes of leukemia and myelodysplasia patients receiving a stem cell transplant from an unrelated donor. Recently published in the journal Bone Marrow Transplantation, a study led by Amir Toor, M.D., hematologist-oncologist in the Bone Marrow Transplant Program and member of the Developmental Therapeutics program at VCU Massey Cancer Center, retrospectively compared the outcomes of 50 patients who received rabbit anti-thymocyte globulin (ATG) before receiving a transplant of stem cells from an unrelated donor to the outcomes of 48 patients who received a transplant of stem cells from a related donor. While unrelated stem cell transplants typically have poorer outcomes than related stem cell transplants, the results from this study showed similar outcomes for each group in terms of mortality, relapse and the development of graft-versus-host disease (GVHD), a common complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks … Continue reading →

6 July 2012 Last updated at 06:47 ET Sea urchins could hold the key to developing cures for major diseases, according to scientists at St Andrews University. They have found a unique genetic sequence in sea urchins and sponges previously only seen in viruses. The process allows the introduction of multiple genes into a single gene, but still lets each new part of the gene create its original protein. The technique could help develop a therapeutic response in human cells. This latest finding builds on the earlier discovery of a short genetic sequence (2A) caused by viruses which can be used to return cells to a stem cell-like state. Martin Ryan, professor of translational virology at the University of St Andrews, was the key researcher in that breakthrough. He said it was a very exciting discovery: "You could put two - or more - different genes into one cell, but each individual gene would be expressed at very different levels." Prof Ryan described the new findings as a massive step forward. The unique sequence was first discovered in the foot-and-mouth disease virus, but has since been seen in other types of virus. More: Sea urchins could be key to cures … Continue reading →

Public release date: 4-Jul-2012 [ | E-mail | Share ] Contact: Daniel Stimson, NINDS nindspressteam@ninds.nih.gov 301-496-5751 NIH/National Institute of Neurological Disorders and Stroke Researchers have taken a step toward personalized medicine for Parkinson's disease, by investigating signs of the disease in patient-derived cells and testing how the cells respond to drug treatments. The study was funded by the National Institutes of Health. The researchers collected skin cells from patients with genetically inherited forms of Parkinson's and reprogrammed those cells into neurons. They found that neurons derived from individuals with distinct types of Parkinson's showed common signs of distress and vulnerability in particular, abnormalities in the cellular energy factories known as mitochondria. At the same time, the cells' responses to different treatments depended on the type of Parkinson's each patient had. The results were published in Science Translational Medicine. "These findings suggest new opportunities for clinical trials of Parkinson's disease, in which cell reprogramming technology could be used to identify the patients most likely to respond to a particular intervention," said Margaret Sutherland, Ph.D., a program director at NIH's National Institute of Neurological Disorders and Stroke (NINDS). A consortium of researchers conducted the study with primary funding from NINDS. The consortium … Continue reading →

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that Proceedings of the National Academy of Sciences of the United States of America (PNAS) July 2, 2012 PNAS Early Edition has published online OncoMed data demonstrating the potent anti-cancer activity of OMP-18R5, the companys first Wnt pathway product candidate, in multiple preclinical human tumor models. OMP-18R5 is currently in Phase 1 clinical testing. OMP-18R5 is, we believe, the first therapeutic antibody to enter clinical trials that specifically inhibits the Wnt pathway, an important pathway in cancer. Our research published in PNAS suggests that inhibiting the Wnt pathway within tumors has the potential to improve treatment for multiple cancers, said Austin Gurney, Ph.D., Senior Vice President, Molecular and Cellular Biology of OncoMed Pharmaceuticals and a co-author of the paper. OMP-18R5 has demonstrated the remarkable ability to drive the differentiation of tumor cells in preclinical models. Tumors become less tumorigenic. The Wnt/beta-catenin pathway, which signals through the Frizzled (Fzd) receptor family and several co-receptors, has long been implicated in cancer. OncoMed researchers identified a novel therapeutic approach to targeting the Wnt pathway with a monoclonal antibody. OMP-18R5, … Continue reading →

COLUMBIA, Md.--(BUSINESS WIRE)-- Osiris Therapeutics, Inc. (OSIR), announced today interim one-year results from its groundbreaking clinical trial evaluating Prochymal (remestemcel-L) for the treatment of patients experiencing first-time acute myocardial infarction. The trial is the largest study of allogeneic or "off-the-shelf" stem cells ever conducted in heart attack patients. A total of 220 patients were given a single infusion of either Prochymal or placebo through a standard intravenous line within seven days of an acute heart attack. Cardiac MRI assessments were conducted for six months following infarct to evaluate cardiac remodeling. Patients receiving Prochymal had significantly less cardiac hypertrophy, as measured by cardiac MRI, compared to patients receiving placebo (p … 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 second patient in its Phase 1/2 clinical trial for Stargardts macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Friday, June 29 at Moorfields Eye Hospital in London, the same site as the first patient treatment in January, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London. The procedure was successfully performed without any complications. ACT and Moorfields Eye Hospital recently received clearance from the Data and Safety Monitoring Board (DSMB) to treat the final two patients in the first cohort of this clinical trial. We are very pleased to continue our forward momentum with both our U.S. trials and our European trial, commented Gary Rabin, chairman and CEO. It was less than a month ago that we received DSMB approval to treat the second and third patients in our E.U. trial, and it is very gratifying to have already completed dosing of the second. It is a pleasure to be … Continue reading →

Halfway around the world in India, Sivaprakash Ramalingam had heard of Johns Hopkins researchers using a promising new technique for gene therapy that he hoped to integrate with stem cells to cure diseases. After getting a doctorate in biochemistry in his native country, he came to Baltimore four years ago to study under the technique's pioneer, Srinivasan Chandrasegaran, at Hopkins' Bloomberg School of Public Health. Ramalingam's research has led him down the path of seeking a cure for sickle cell anemia, a painful, life-shortening blood disorder that afflicts many in his home region in southern India. In the United States, the disease affects 70,000-100,000 people, mostly African-Americans, according to the National Heart Lung and Blood Institute. "I couldn't have done this type of research in India," said Ramalingam. "I wanted to use this technique with stem cells to treat disease." Ramalingam's research was given a lift last month by the state. He was one of 17 researchers who was funded by the Maryland Stem Cell Research Commission, a state entity that has doled out roughly $10 million to $12 million a year in taxpayer funds since its founding in 2006. The program helps keep Maryland competitive in stem cell research … Continue reading →

Halfway around the world in India, Sivaprakash Ramalingam had heard of Johns Hopkins researchers using a promising new technique for gene therapy that he hoped to integrate with stem cells to cure diseases. After getting a doctorate in biochemistry in his native country, he came to Baltimore four years ago to study under the technique's pioneer, Srinivasan Chandrasegaran, at Hopkins' Bloomberg School of Public Health. Ramalingam's research has led him down the path of seeking a cure for sickle cell anemia, a painful, life-shortening blood disorder that afflicts many in his home region in southern India. In the United States, the disease affects 70,000-100,000 people, mostly African-Americans, according to the National Heart Lung and Blood Institute. "I couldn't have done this type of research in India," said Ramalingam. "I wanted to use this technique with stem cells to treat disease." Ramalingam's research was given a lift last month by the state. He was one of 17 researchers who was funded by the Maryland Stem Cell Research Commission, a state entity that has doled out roughly $10 million to $12 million a year in taxpayer funds since its founding in 2006. The program helps keep Maryland competitive in stem cell research … Continue reading →