Category Archives: Stem Cell Human Trials

UW-Madison cell and regenerative biology professor James Thomson and his team of scientists recently made new strides in their extensive stem cell research. Thomson and his team members from the Morgridge Institute for Research conducted tests and experiments on mice to advance their research, according to a UW-Madison news release. Results from the trials led to a developed method which eternally preserves progenitor cells in their pluripotent stages. In other words, the stem cells, which eventually transform into specific tissues, will forever remain in a phase with the potential to become one of at least 200 different cell types. Maintaining pluripotent stem cells in a controlled environment enables them to undergo constant reproduction. The cells will cyclically divide and grow to produce working endothelial, blood and smooth muscle cells. David Vereide, one of Thomsons associates at MIR, said the cells are able to self-renew through the regulation of a small quantity of genes. "Normally, these cells are ephemeral and get used up while differentiating into specific cell types, but we found a way to interrupt that, Vereide explained in the release. He also said their findings bring researchers very close to finalizing medical uses for stem cells. Thomson said in … Continue reading →

International Stem Cell Corp., a Carlsbad-based biotech company developing stem cell therapies and biomedical products, announced that the U. S. Food and Drug Administration has cleared the companys human parthenogenetic stem cells line for investigational clinical use. Human embryonic stem cells typically come from fertilized eggs. In 2007, however, scientists at International Stem Cell Corp. (ISCO) reported the first successful creation of human stem cell lines from unfertilized eggs, according to Scientific American. They used a process called parthenogenesis, in which researchers use chemicals to induce the egg to begin developing as if it had been fertilized. The egg called a parthenote behaves just like an embryo in the early stages of division. Because it contains no genetic material from a father, however, it cannot develop into a viable fetus. Just like embryonic stem cells, parthenogenetic stem cells can be coaxed to grow into different kinds of human cells or tissue, ready to be transplanted into diseased areas of the body. "Many stem cell lines can never be used to develop commercial therapeutic products because they don't meet the FDA's ethical and quality standards, said Ruslan Semechkin, ISCOs chief scientific officer. With this clearance from the FDA, based on the … Continue reading →

Scientists at Sweden's Lund University have hailed study a 'breakthrough' Found stem cells can heal the damage caused by Parkinson's disease Parkinson's UK said there remain many questions before human trials By Ben Spencer, Science Reporter for the Daily Mail Published: 08:18 EST, 7 November 2014 | Updated: 09:14 EST, 7 November 2014 223 shares 25 View comments Stem cells can be used to heal the damage in the brain caused by Parkinson's disease, according to scientists in Sweden. They said their study on rats heralded a 'huge breakthrough' towards developing effective treatments. There is no cure for the disease, but medication and brain stimulation can alleviate symptoms. Parkinson's UK said there were many questions still to be answered before human trials could proceed. Original post: Damage to the brain caused by Parkinson's can be 'healed' using stem cells … Continue reading →

Renevia has the potential to be the first approved product that allows cells to be easily transplanted through a syringe and then safely polymerized into three-dimensional tissue constructs within the human body, said William Tew, Ph.D., BioTimes Chief Commercial Officer. We are excited to enter this last phase of clinical trials for Renevia as well as by the promise of this technology for the transplantation of other types of cells to address unmet medical needs. BioTime considers Renevia a key strategic asset for its future regenerative medicine programs which are focused on the development of human embryonic stem cell-derived brown adipocytes, vascular, and osteochondral cells to treat tissues afflicted with degenerative disease. If the pivotal trial meets its primary end points, then we would expect to submit Renevia for CE Mark approval in 2016. About the Renevia Clinical Trial The Spanish Agency of Medicines and Medical Devices (AEMPS) authorized BioTime to conduct a randomized, evaluator-blinded, delayed-treatment-controlled study of the effectiveness and safety of Renevia as a resorbable matrix for the delivery of autologous adipose-derived cells to treat subcutaneous facial lipoatrophy defects arising from HIV infection. The study will include a minimum of 56 and up to 92 HIV positive males … Continue reading →

OpRegen consists of animal product-free retinal pigment epithelial (RPE) cells with high purity and potency that were derived from human embryonic stem cells (hESCs). Cell Cure will conduct the trial in Israel where OpRegen will be transplanted as a single dose into the subretinal space of the eye to test the safety and efficacy of the product. Patient enrollment is expected to begin in 2014 following approval of the trial by the Israel Ministry of Health. About the OpRegenClinical Trial Cell Cures Phase I/IIa clinical trial is a dose escalation safety and preliminary efficacy study of hESC-derived Retinal Pigment Epithelial (RPE) cells transplanted subretinally in patients with advanced dry-form AMD called geographic atrophy. The open-label, single center, nonrandomized trial will evaluate three different dose regimens of 50,000 to 500,000 cells. A total of 15 patients will be enrolled. The patients will be 55 years of age and older, with non-neovascular (dry-AMD) who have funduscopic findings of GA in the macula with absence of additional concomitant ocular disorders. The eye most affected by the disease will be treated with the contralateral eye being the control. Following transplantation, the patients will be followed for 12 months at specified intervals, to evaluate the … Continue reading →

UC San Diego has been named an "alpha clinic" for the clinical study of stem cells, and the distinction comes with $8 million in research grants. Stem cell therapies represent a new way of treating disease by regenerating damaged tissues and organs. Spokesmen for the UCSD school of medicine say the alpha clinic will focus on clinical trials in humans, not just basic research based on animals. The decision to make UCSD an alpha clinic was announced Friday by the California Institute for Regenerative Medicine, which was created by California voters after they approved $3 billion for stem cell funding in 2004. Everything we do has one simple goal, to accelerate the development of successful treatments for people in need, said C. Randal Mills, CIRM president and CEO. Catriona Jamieson, professor of medicine at UC San Diego School of Medicine, is the alpha clinic grants principal investigator. She said the clinic will provide needed infrastructure for first-in-human stem cell-related clinical trials. "It will attract patients, funding agencies and study sponsors to participate in, support and accelerate novel stem cell clinical trials and ancillary studies for a range of arduous diseases, Jamieson said. The university has already announced human stem cell … Continue reading →

SAN DIEGO (CNS) - UC San Diego Health System announced Monday that human testing of injected neural stem cell therapies are underway at its Sanford Stem Cell Clinical Center. Researchers are conducting three different trials -- one on a 26-year-old woman paralyzed after a traffic crash, and others on diabetes and leukemia patients. "What we are seeing after years of work is the rubber hitting the road," said Lawrence Goldstein, director of the UC San Diego Stem Cell program and Sanford Stem Cell Clinical Center. "These are three very ambitious and innovative trials," he said. "Each followed a different development path -- each addresses a very different disease or condition. It speaks to the maturation of stem cell science that we've gotten to the point of testing these very real medical applications in people." The first tests are being made with low doses in order to ensure the safety of the patients, Goldstein said. Working with Maryland-based Neuralstem Inc., neural stem cells were injected into the site of the paralyzed woman's spinal cord injury on Sept. 30, and she is recovering at home without complications or adverse effects, said Dr. Joseph Ciacci, a neurosurgeon at UC San Diego Health System. … Continue reading →

A 26-year-old woman paralyzed after a motor vehicle accident a year ago has successfully undergone a first-in-human experimental procedure to test whether neural stem cells injected at the site of a spinal cord injury is safe and could be an effective treatment. The procedure, conducted on Sept. 30 under the auspices of the Sanford Stem Cell Clinical Center at UC San Diego Health System and in collaboration with Neuralstem, Inc., a Maryland-based biotechnology firm, is the first of four in the Phase I clinical trial. Post safety testing, it's hoped that the transplanted neural stem cells will develop into new neurons that bridge the gap created by the injury, replace severed or lost nerve connections and restore at least some motor and sensory function. The patient, whose identity remains confidential for privacy reasons, has been discharged and is recovering without complication or adverse effects at home, said Joseph Ciacci, MD, principal investigator and neurosurgeon at UC San Diego Health System. The spinal cord injury trial is one of three recent ground-breaking stem cell efforts at UC San Diego, supported by the Sanford Stem Cell Clinical Center, to make the significant leap from laboratory to first-in-human clinical trials. Last month, researchers … Continue reading →

SAN DIEGO (CNS) - UC San Diego Health System announced Monday that human testing of injected neural stem cell therapies are underway at its Sanford Stem Cell Clinical Center. Researchers are conducting three different trials -- one on a 26-year-old woman paralyzed after a traffic crash, and others on diabetes and leukemia patients. "What we are seeing after years of work is the rubber hitting the road," said Lawrence Goldstein, director of the UC San Diego Stem Cell program and Sanford Stem Cell Clinical Center. "These are three very ambitious and innovative trials," he said. "Each followed a different development path -- each addresses a very different disease or condition. It speaks to the maturation of stem cell science that we've gotten to the point of testing these very real medical applications in people." The first tests are being made with low doses in order to ensure the safety of the patients, Goldstein said. Working with Maryland-based Neuralstem Inc., neural stem cells were injected into the site of the paralyzed woman's spinal cord injury on Sept. 30, and she is recovering at home without complications or adverse effects, said Dr. Joseph Ciacci, a neurosurgeon at UC San Diego Health System. … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, reported today that its proprietary iPSC Platelet technology is potentially capable of producing large-scale quantities of universal donor platelets for transfusion in almost any patient. The research, which appears online (published-ahead-of- print) in Stem Cell Reports the official journal of the International Society for Stem Cell Research (ISSCR) and published by Cell Press by ACT scientists and their colleagues, shows that it is feasible to generate megakaryocytes and platelets from iPSCs in a scalable manner under feeder-free defined conditions. Universal platelets were generated by removing a gene essential to expression of the major histocompatibility (HLA) antigens, which are the main molecules responsible for cell and organ rejection. The platelets generated using this technology are functional and display features that were indistinguishable from those of human blood platelets. The proprietary iPSC technology incorporates several discreet intermediate cells including proprietary hemogenic endothelium like cells. Unlike platelets this technology allows for long term storage of cell material to be available and ready for transfusion within a few days when needed to produce large quantities of platelets from fully differentiated cells. Unlike other sources of platelets, said … Continue reading →