Category Archives: Stem Cell Human Trials

A team of British scientists has released a major study that could represent a breakthrough in the treatment of human neurological diseases, such as Alzheimer's or Parkinson's. In a study published Wednesday in the journal Science Translational Medicine, the team said that it had halted brain cell death in mice by using a drug-like compound that was injected into the animals' stomachs through a mouth tube. The team induced a neurodegenerative disease caused by abnormal prion proteins -- the nearest model of human disorders that can be found in animals -- before treating one group with the compound. According to the study, the mice who were treated remained free of symptoms like memory loss, impaired reflexes, and limb dragging five weeks later. The treated mice also lived longer than the untreated mice. "We were extremely excited when we saw the treatment stop the disease in its tracks and protect brain cells, restoring some normal behaviours and preventing memory loss in the mice, " lead scientist Giovanna Mallucci told Sky News. The study stresses that human trials have yet to be undertaken, and points out that it could be a decade or more before a medicine for the treatment of human … Continue reading →

Durham, NC (PRWEB) October 10, 2013 Researchers have discovered a new, highly efficient way to produce neural stem cells from human pluripotent stem cells that can then go on to form neurons in the brain. The discovery, reported in the current issue of STEM CELLS Translational Medicine, could greatly accelerate the development of new drug and cell therapies for people suffering from brain injuries or disease. Human pluripotent stem cells (hPSCs), including human embryonic stem cells (hESCs) and human induced pluripotent stem cells (hiPSCs), show great promise in regenerative medicine due to their ability to be coaxed into becoming different specific types of cells. These cells can theoretically then go on to help the body heal itself by replacing or repairing damaged or dead cells. However, the current methods for inducing neural stem cells involve time-consuming, multiple labor-intensive steps that cannot be easily automated or made GMP (good manufacturing practice) compliant for clinical grade manufacture. In addition, not many of the neural stem cells produced this way can be expanded and coaxed into becoming different neural subtypes specific to the brain regions responsible for controlling different functions. Towards this critical need, we have developed a simple one-step protocol with a … Continue reading →

NEWARK, Calif., Oct. 8, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that it has closed its previously announced underwritten public offering of common stock and warrants. The Company sold a total of 12,845,500 units, which includes the underwriter's full over-allotment option. The Company sold the units at a public offering price of $1.45 per unit and received total proceeds, net of offering expenses, underwriting discounts and commissions, of approximately $17.3 million. Each unit sold consists of one share of common stock, par value $.01 per share, and a warrant to purchase one half share of common stock. The warrants have an exercise price of $1.80 per share, are exercisable immediately, and will expire five years from the date of issuance. Chardan Capital Markets acted as sole bookrunner for the offering and Maxim Group LLC acted as co-manager. In connection with the offering, the Company terminated its $30 million equity purchase agreement with Lincoln Park Capital. Lincoln Park Capital participated in the offering as an investor. About StemCells, Inc. StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, … Continue reading →

SAN DIEGO, Oct. 3, 2013 (GLOBE NEWSWIRE) -- Medistem, Inc. (Pink Sheets: MEDS), announced today that it filed patent application #61/885909 covering immune modulatory aspects of ERC-124, the Company's clinical-stage stem cell product. The provisional patent titled, "TOLEROGENIC USES OF ENDOMETRIAL REGENERATIVE CELLS", was invented by Thomas Ichim, Ph.D., Chief Scientific Officer of Medistem, and Hugh Taylor, M.D., Professor of Molecular, Cellular, and Developmental Biology at Yale University and a member of the Company's Scientific Advisory Board. The patent application includes data that defines the mechanism by which ERC-124 therapy prevented Type 1 Diabetes and other autoimmune conditions in animal models. Specifically, the animal study demonstrated that ERC-124 activates T regulatory cells, a cell type known to block autoimmunity by controlling pathological autoreactive T cells. "The ERC-124 product has been cleared by the FDA for clinical trials in another indication and we are optimistic about the potential of clinically developing our product as a therapy to treat conditions in the field of autoimmunity," said Alan Lewis, Ph.D., the Company's Chief Executive Officer. Medistem has been active in the area of autoimmune diseases, with the first human use of ERC-124 being reported in 4 patients with multiple sclerosis (link to publication … Continue reading →

As a participant in a clinical trial, Mike McReynolds of Fort Worth could be one of the first patients with gliobastoma (a type of brain tumor) to benefit from a brand-new treatment. Or not. He could be getting a placebo. And no ones guaranteeing the new treatment works. But McReynolds, 69, jokingly calls his decision to join the clinical trial a no-brainer. Almost two years after diagnosis, hes feeling good and working full time, and he credits the trial. Many more cancer patients stand to benefit from clinical trials, and with hundreds of anti-cancer drugs in the pipeline, researchers could make faster progress if more volunteered. But less than 3 percent of adult cancer patients in the United States participate in clinical trials, according to the National Cancer Institute. Many doctors dont encourage patients to volunteer, and patients fear theyll compromise their treatment if they do. But clinical trials for cancer dont work the way many assume. Here are some misconceptions and some facts. Myth No. 1: Placebo means no treatment. Many patients are scared off from clinical trials out of fear theyll get a placebo, says Dr. Karen L. Fink, a neuro-oncologist at Baylor Charles A. Sammons Cancer Center … Continue reading →

Scientists have created stem cells within the body of laboratory mice for the first time in a landmark study showing that it may be possible one day to repair damaged human organs in situ without the need for transplant operations. Until now stem cells created by a new genetic engineering technique have only been created in vitro in the laboratory, but the researchers were able to perform gene therapy on living mice to generate the stem cells in vivo. If the work can be transferred safely to humans it raises the possibility of generating stem cells at the site of a diseased organ, such as heart or pancreas, so that a persons own stem cells could be generated to repair any damaged tissue. We think this opens new possibilities in regenerative medicine...One possible advantage over other stem cell techniques is that the cells are already there in the right place with the possibility of becoming functional cells - with no need for grafts, said Manuel Serrano of the Spanish National Cancer Research Centre in Madrid. We can now start to think about methods for inducing regeneration locally and in a transitory manner for a particular damaged tissue, said Dr Serrano, … Continue reading →

REDWOOD CITY, Calif., Sept. 25, 2013 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that the United States Patent and Trademark Office has granted OncoMed its third broad U.S. patent relating to antibodies that target the RSPO-LGR pathway, which is believed to be an important CSC pathway. The new patent, U.S. Patent No. 8,540,989, covers methods of treating cancer with antibodies that bind human R-spondin (RSPO) proteins and either disrupt the binding of such proteins to their receptors, the leucine-rich repeat-containing G-coupled receptors (LGRs), or disrupt RSPO activation of LGR signaling. The new patent is based on key discoveries by OncoMed scientists that RSPO proteins signal through the LGR receptor family and that antibodies that disrupt binding of RSPO proteins to LGRs or that disrupt RSPO activation of LGR signaling are potential anti-cancer agents. OncoMed has identified multiple antibodies targeting the RSPO-LGR pathway and demonstrated the activity of these antibodies in preclinical studies. OncoMed plans to file an Investigational New Drug filing on its first antibody targeting the RSPO-LGR pathway in as early as 2014. OncoMed has worldwide rights to all of its RSPO-LGR … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has filed an Investigational New Animal Drug (INAD) application with the Food and Drug Administration (FDA) to test its proprietary off-the-shelf mesenchymal stem cells (MSC) in a range of different disease indications. The studies will evaluate the safety and efficacy of ACTs pluripotent stem cell-derived MSCs in ten spontaneous disease models in dogs, which are similar to various human inflammatory and immune-mediated diseases. While these companion animal studies represent research intended for ultimate licensure of veterinary therapeutics, ACT anticipates that the trial results may be relevant to its path to clinical trials in human patients and may provide a more robust assessment of safety and therapeutic endpoints than what can be obtained from inbred rodent models. The INAD is directed to ten canine disorders corresponding to hepatitis, glomerulonephritis, osteoarthritis, Crohns disease, inflammatory bowel disease, spinal cord/disc disease, meningoencephalitis, hemolytic anemia, pancreatitis and sepsis. This INAD filing extends our ongoing work with world experts in veterinary and regenerative medicine , said Robert Lanza, M.D., chief scientific officer of ACT. Preliminary studies in rodents have shown that our hESC-derived MSCs … Continue reading →

New York (PRWEB) September 18, 2013 Scientists from the Icahn School of Medicine at Mount Sinai, in partnership with the New York Stem Cell Foundation (NYSCF), and other institutions, have been awarded a multi-year grant from the National Institutes of Health (NIH) to study Alzheimers disease. This study will apply innovative analytical methods to large-scale molecular, cellular, and clinical data from Alzheimers patients to construct biological network models and gain new insights into the complex mechanisms of the disease, and identify potential therapeutic targets. Biological network models are complex mathematical representation of large amounts of data. These networks provide a unified map that integrates not only the key genes involved in a disease but also the biological pathways that those genes control. The NIH grant will enable the research team at Mount Sinai and partner institutions to build upon the discovery published earlier this year in the journal Cell of a network of genes as a key mechanism driving Late Onset Alzheimers Disease (LOAD) through involvement in the inflammatory response in the brain. Eric Schadt, PhD, The Jean C. and James W. Crystal Professor of Genomics at the Icahn School of Medicine at Mount Sinai, and Director of the Icahn … Continue reading →

NEWARK, Calif., Sept. 18, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced the publication of preclinical data confirming that the Company's proprietary HuCNS-SC cells (purified human neural stem cells) preserve photoreceptor cells and visual function in a widely used model of retinal degeneration. The data show not only that HuCNS-SC cells preserve the number of photoreceptors that would otherwise be lost, but also that the surviving photoreceptors appear healthy and normal, and maintain their synaptic connection to other important cells necessary for visual function. The study was published in Investigative Ophthalmology and Visual Science (IVOS), the journal of the Association for Research in Vision and Ophthalmology, and is available at (http://www.iovs.org/content/early/recent.) These results are highly relevant to disorders of vision loss, the most notable of which is age-related macular degeneration (AMD), which afflicts approximately 30 million people worldwide. "This study demonstrates that, at the cellular and sub-cellular level, the surviving photoreceptors have all the components that characterize a healthy and normal photoreceptor, and they have the correct synaptic connections," said Nicolas Cuenca, PhD, Professor in the Department of Physiology, Genetics and Microbiology at the University of Alicante, Spain, and lead author of the paper. "The robust anatomical preservation of … Continue reading →