Category Archives: Stem Cell Human Trials

John B. Gurdon transferred DNA between a tadpole and a frog to clone the first animal. Shinya Yamanaka used Gurdons concept to turn ordinary skin into potent stem cells. Both won the Nobel Prize for medicine today. Gurdon, 79, a researcher at the University of Cambridge in the U.K., and Yamanaka, 50, a professor at Kyoto University in Japan, will share the 8 million-kronor ($1.2 million) prize, the Nobel Assembly said today in Stockholm. The pairs findings have created new opportunities to study diseases and develop methods for diagnosis and therapy, the assembly said in a statement. Gurdons feat, in 1962, paved the way in 1996 for the cloning of Dolly the sheep and, 10 years later, for Yamanaka, who turned mouse skin cells into stem cells with the potential to become any cell in the body. That achievement was lauded by some politicians and religious figures as a more ethical way to make stem cells because it doesnt destroy human life. This field has had a long history, starting with John Gurdon, Yamanaka, who was born the same year Gurdon published his achievement, said in an interview on the Nobel Assemblys website. I was able to initiate my project … Continue reading →

And rightly so: stem-cell scientists have derived many types of cells from stem-cell precursors, but have in the past struggled with sex cells. The research by a team at Kyoto University provides a powerful model into mammalian development and infertility, but it is still a long way off from being used in human therapy. Despite this fact, it did not stop the headlines in some of today's press screaming that infertile women could one day become pregnant by creating eggs from stem cells. Evelyn Telfer, a reproductive biologist at the University of Edinburgh, told me this study has no clinical application to humans whatsoever because the tissue used in this study were all foetal and not adult cells. Mitinori Saitou led a team using foetal mouse tissue from embryos or skin cells to create stem cells. Those stem cells were then genetically reprogrammed to become germ cells egg precursor cells. These were then given a cocktail of "factors" to support their growth into mature eggs. The eggs were fertilised by IVF in the lab and then implanted into surrogate mice. Three baby mice were born and grew into fertile adults. The fact that artificially manufactured eggs have gone on to … Continue reading →

NEWARK, Calif., Oct. 4, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the first patient in its Phase I/II clinical trial in dry age-related macular degeneration (AMD) has been enrolled and transplanted. The trial is designed to evaluate the safety and preliminary efficacy of the Company's proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) as a treatment for dry AMD, and the patient was transplanted with the cells yesterday at the Retina Foundation of the Southwest (RFSW) in Dallas, Texas, one of the leading independent vision research centers in the United States. AMD afflicts approximately 30 million people worldwide and is the leading cause of vision loss and blindness in people over 55 years of age. "This trial signifies an exciting extension of our on-going clinical research with neural stem cells from disorders of the brain and spinal cord to now include the eye," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "Studies in the relevant animal model demonstrate that the Company's neural stem cells preserve vision in animals that would otherwise go blind and support the therapeutic potential of the cells to halt retinal degeneration. Unlike others … Continue reading →

Newswise LOS ANGELES (Oct. 2, 2012) Researchers at Cedars-Sinais Maxine Dunitz Neurosurgical Institute have found that a blood vessel-building gene boosts the ability of human bone marrow stem cells to sustain pancreatic recovery in a laboratory mouse model of insulin-dependent diabetes. The findings, published in a PLoS ONE article of the Public Library of Science, offer new insights on mechanisms involved in regeneration of insulin-producing cells and provide new evidence that a diabetics own bone marrow one day may be a source of treatment. Scientists began studying bone marrow-derived stem cells for pancreatic regeneration a decade ago. Recent studies involving several pancreas-related genes and delivery methods transplantation into the organ or injection into the blood have shown that bone marrow stem cell therapy could reverse or improve diabetes in some laboratory mice. But little has been known about how stem cells affect beta cells pancreas cells that produce insulin or how scientists could promote sustained beta cell renewal and insulin production. When the Cedars-Sinai researchers modified bone marrow stem cells to express a certain gene (vascular endothelial growth factor, or VEGF), pancreatic recovery was sustained as mouse pancreases were able to generate new beta cells. The VEGF-modified stem cells promoted … Continue reading →

Public release date: 3-Oct-2012 [ | E-mail | Share ] Contact: Garth Sundem garth.sundem@ucdenver.edu University of Colorado Denver The University of Colorado Cancer Center, together with other participating academic medical centers, recently opened a phase I human clinical trial of the drug OMP-54F28 in patients with advanced solid tumor cancers. OMP-54F28, a candidate investigational drug discovered by OncoMed Pharmaceuticals, targets cancer stem cells (CSCs), also known as tumor-initiating cells, which many researchers believe are at the root of tumor occurrence and growth. These CSCs are notoriously resistant to existing chemotherapies and so may survive current treatments to repopulate a tumor, leading to relapse and metastasis. "It's a terrific opportunity to put a drug targeting cancer stem cells in the clinic, especially a drug with as much promise in preclinical studies as this one," says Antonio Jimeno, MD, PhD, investigator at the CU Cancer Center, director of the university's Cancer Stem Cell-Directed Clinical Trials Program, and principal investigator of the clinical trial at the CU Cancer Center site. "It is a privilege to work with such a science-focused partner, whose vision totally aligns with ours: bringing to the clinic cutting-edge drugs and ideas that are supported by robust scientific data. In … Continue reading →

Public release date: 2-Oct-2012 [ | E-mail | Share ] Contact: Sandy Van sandy@prpacific.com 808-526-1708 Cedars-Sinai Medical Center LOS ANGELES (Oct. 2, 2012) Researchers at Cedars-Sinai's Maxine Dunitz Neurosurgical Institute have found that a blood vessel-building gene boosts the ability of human bone marrow stem cells to sustain pancreatic recovery in a laboratory mouse model of insulin-dependent diabetes. The findings, published in a PLOS ONE article of the Public Library of Science, offer new insights on mechanisms involved in regeneration of insulin-producing cells and provide new evidence that a diabetic's own bone marrow one day may be a source of treatment. Scientists began studying bone marrow-derived stem cells for pancreatic regeneration a decade ago. Recent studies involving several pancreas-related genes and delivery methods transplantation into the organ or injection into the blood have shown that bone marrow stem cell therapy could reverse or improve diabetes in some laboratory mice. But little has been known about how stem cells affect beta cells pancreas cells that produce insulin or how scientists could promote sustained beta cell renewal and insulin production. When the Cedars-Sinai researchers modified bone marrow stem cells to express a certain gene (vascular endothelial growth factor, or VEGF), pancreatic recovery … Continue reading →

HOUSTON, Oct. 1, 2012 /PRNewswire/ --Celltex Therapeutics Corp. announced today that it has received a letter, dated Sept. 24, 2012, from the U.S. Food and Drug Administration. The letter stated the agency's opinion that the process Celltex uses to multiply adult stem cells is subject to FDA regulation as biological drug manufacturing. The issue is a key one as stem cell therapy for patient care outside of an academic institution is a new frontier, yet there are a variety of technologies being used throughout the United States, often creating complex legal and regulatory questions. David Eller, CEO and President of Celltex, stated: Celltex makes identical copies of an individual's own stem cells and therefore should not be subject to FDA regulation as drugs. However, the FDA said our process causes the cells to be considered biological drugs and thus is subject to those regulations. We respectfully but firmly disagree with the FDA and intend to contest the agency's opinion within its administrative procedures. We are considering all options as we work with the agency toward a resolution. FDA's letter also repeats its earlier observations from an April inspection of Celltex's laboratory. While Celltex provided detailed responses in April, May, June, … Continue reading →

NEWARK, Calif., Sept. 27, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the first patient with an incomplete spinal cord injury has been enrolled in the Company's Phase I/II clinical trial in chronic spinal cord injury and transplanted with the Company's proprietary HuCNS-SC(R) neural stem cells. The patient, a Canadian man who suffered a thoracic spinal cord injury from a sports-related accident, was administered the cells yesterday at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation. This is the first patient in the second cohort of the trial, which will be comprised of four patients who retain some sensory function below the level of trauma and are therefore considered to have an incomplete injury. "This is an important milestone for StemCells and the spinal cord injury community as it is the first time anyone has ever transplanted neural stem cells into a patient with an incomplete injury," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "Given the encouraging interim data from the most severely injured patient cohort that we reported earlier this month, testing patients with less severe injury should … Continue reading →

CARLSBAD, Calif., Sept. 27, 2012 /PRNewswire/ --Life Technologies Corporation (LIFE) today announced it has received FDA 510(k) clearance for its OpTmizer CTS T-Cell Expansion Tissue Culture Medium a reagent that is now cleared as a Class II medical device and offers cost- and time-saving advantages for transitioning studies from the research bench to clinical trials. The OpTmizer CTS T-Cell Expansion Tissue Culture Medium is intended for human ex vivo (outside the body) tissue and cell culture processing application. This means it is designed to efficiently grow large numbers of potentially therapeutic T-cells, whichhave demonstrated promise in clinical studies as an effective treatment for diseases including cancer, infectious diseases such as AIDS, and autoimmune disorders. "We are very pleased to learn of Life Technologies' successful outcome in achieving its FDA 510(k) regulatory clearance for its OpTmizer CTS T-Cell Expansion Tissue Culture Medium, and we value the close working relationship we have established with Life Tech," said Neil K. Warma, President & CEO of Opexa Therapeutics, Inc. "The receipt of 510(k) status for OpTmizer CTS T-cell expansion media simplifies the regulatory path for Opexa as we continue the development of Tcelna, a T-cell immunotherapy for the treatment of patients with multiple sclerosis." … Continue reading →

NOKOMIS, Fla.--(BUSINESS WIRE)-- As Rainbow BioSciences, the biotech subsidiary of Rainbow Coral Corp. (RBCC), works to acquire licensing for commercial use of NASA-developed stem cell expansion technology, the company received good news from a Wall Street analysts forecast on Wednesday. Writing for Seeking Alpha, George Kesarios predicted major growth for the global stem cell market in coming years. Its estimated that the market will be worth about $64 billion by 2015, up from $21.5 billion in 2010. Kesarios attributed the growth largely to a potential revolution in drug companies research and development made possible by an abundance of induced pluripotent stem cells. With these stem cells, scientists can actually create working facsimiles of living human tissue, introduce diseases and observe how they unfold under a microscope, said RBCC CEO Patrick Brown. Spending a decade on research only to discover in trials that a drug doesnt work could become a thing of the past. Stem cells hold the key to the future of profitable, effective drug development. Thats why RBCC has engaged Regenetech in discussions regarding the potential acquisition of a license to perform cell expansion using that companys Rotary Cell Culture SystemTM. The Rotary Cell Culture SystemTM is a rotating-wall … Continue reading →