Category Archives: Stem Cell Human Trials

Scientists have developed a blood test using human stem cells that predicts whether new drugs will cause severe side effects. The test, which only requires blood from a single donor, could help prevent catastrophic inflammatory reactions known as a cytokine storm in people participating in drug trials. "As biological therapies become more mainstream, its more likely that drugs being tested on humans for the first time will have unexpected and potentially catastrophic effects," says Professor Jane Mitchell from the National Heart and Lung Institute at Imperial College London, who led the study. "Weve used adult stem cell technology to develop a laboratory test that could prevent another disaster like the TGN1412 trial." In 2006 six healthy young men were hospitalized with multiple organ failure after experiencing a cytokine storm as a result of taking part in the first tests in humans of the drug TGN1412. Tests on human cells are essential because biological therapies, or "biologics" (such as the cancer drugs Herceptin and Avastin), use antibodies which are specific to humans. They can cause severe reactions, such as a cytokine storm, that dont occur in animal studies. Cytokine storm reactions are difficult to predict using tests where just one cell … Continue reading →

Boston, MA (PRWEB) March 24, 2015 The opening keynote address presented by Asymmetrex, LLC to an assembled audience of about 100 international experts in stem cell science, medicine, and engineering challenged attendees to consider whether the past 10 years of rapid growth of heterologous stem cell transplantation trials was the best path to achieving effective regenerative medicines. Among the participants there were a number of clinical and industry experts who pursued heterologous stem cell treatments. To a large extent, heterologous stem cell transplantation treatments involve evaluating bone marrow-derived or fat-derived cells as possible therapies for illnesses and disorders in other organs and tissues. Sherley suggested that such clinical trials were motivated primarily by the easier access and greater availability of these types of cell preparations instead of good biological rationale. This intentional provocation got the conference off to energetic discussion that continued throughout the day. As the co-chair of the conferences first-days focus on stem cell medical engineering, Sherley shared with attendees Asymmetrexs essential technological basis, which is the asymmetric self-renewal of adult tissue stem cells. Sherley related how all Asymmetrexs innovative technologies for advancing stem cell medicine were derivative of the companys superior research position on asymmetric self-renewal, which … Continue reading →

IMAGE:This is an image of macro-encapsulated pancreatic endocrine cells derived from human embryonic stem cells. Devices were harvested at 29 weeks post-transplant and immunofluorescent staining was performed for insulin... view more Scientists at the University of British Columbia and BetaLogics, part of Janssen Research & Development, LLC have shown for the first time that Type 2 diabetes can be effectively treated with a combination of specially-cultured stem cells and conventional diabetes drugs. Stem cells - generic cells that haven't yet taken on specialized form and function - have recently been used by scientists at UBC and elsewhere to reverse Type 1 diabetes in mice. In Type 1 diabetes, which usually begins in childhood, the pancreas produces little or no insulin, the hormone that enables cells to metabolize sugar. These new results, published today in Stem Cell Reports, hold much broader potential because Type 2 diabetes - which usually arises in adulthood, often stemming from poor diet, lack of exercise and obesity - accounts for more than 90 per cent of diabetes cases. Timothy Kieffer, a professor in the department of cellular and physiological sciences, and scientists from BetaLogics simulated Type 2 diabetes in mice by putting them on a high-fat, … Continue reading →

Comments(0) Cambridge stem cell scientists searching for new cystic fibrosis treatments have grown "mini-lungs" in a laboratory. The millimetre-wide cell clusters were created using stem cells derived from the skin of patients with the devastating lung disease. They are the latest in a line of 3D "organoids" produced to mimic the behaviour of specific body tissues, following "mini-brains" for studying Alzheimer's disease and "mini-livers" to model diseases of the liver. Dr Nick Hannan, led the team from Cambridge University. He said: "In a sense, what we've created are 'mini-lungs'. "While they only represent the distal (outer) part of lung tissue, they are grown from human cells and so can be more reliable than using traditional animal models, such as mice. "We can use them to learn more about key aspects of serious diseases - in our case, cystic fibrosis." Cystic fibrosis occurs when the movement of water to the inside of the lungs is reduced, causing a build up of thick mucus that leads to a high risk of infection. The scientists reprogrammed ordinary skin cells to create stem cells that could be transformed into lung tissue. More: Stem cell "mini-lungs" created in Cambridge University lab … Continue reading →

GERMANTOWN, Md., March 16, 2015 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) (the "Company" or "Neuralstem") today reported its financial results for the fourth quarter and year ended December 31, 2014. "Neuralstem has progressed into a clinical development stage company focused on the central nervous system (CNS)," said Richard Garr, Neuralstem President and CEO. "During 2014 we added two established industry leaders as Independent Directors, Catherine Angell Sohn, Pharm.D. and Sandford Drexel Smith. Dr. Sohn is the former Senior Vice President of Business Development and Strategic Alliance, GSK Consumer Healthcare, at GlaxoSmithKline. Mr. Smith is the former Executive Vice President of Genzyme Corporation. The Company moved forward two lead clinical assets: our small molecule neurogenic drug candidate NSI-189 and our spinal derived neural stem cell therapeutic candidate NSI-566. We established and/or grew clinical research programs with leading investigators at Emory University, University of California, San Diego (UCSD), University of Michigan and Massachusetts General Hospital. Our investigators published and presented proof of principle data in both lead assets as highlighted below. In 2015, we plan to begin clinical development of our NSI-189 small molecule drug in a second indication for the treatment of cognitive deficit from schizophrenia, and we plan to … Continue reading →

A call by scientists to halt to precision gene-editing of DNA in human embryos would allow time to work out safety and ethical issues Sperm cell fertilizing an egg. Credit: Wikimedia Commons Amid rumors that precision gene-editing techniques have been used to modify the DNA of human embryos, researchers have called for a moratorium on the use of the technology in reproductive cells. In a Comment published on March 12 inNature, Edward Lanphier, chairman of the Alliance for Regenerative Medicine in Washington DC, and four co-authors call on scientists to agree not to modify human embryos even for research. Such research could be exploited for non-therapeutic modifications. We are concerned that a public outcry about such an ethical breach could hinder a promising area of therapeutic development, write Lanphier and his colleagues, who include Fyodor Urnov, a pioneer in gene-editing techniques and scientist at Sangamo BioSciences in Richmond, California. Many groups, including Urnov's company, are already using gene-editing tools to develop therapies that correct genetic defects in people (such as by editing white blood cells). They fear that attempts to produce designer babies by applying the methods to embryos will create a backlash against all use of the technology. Known … Continue reading →

Amid rumours that precision gene-editing techniques have been used to modify the DNA of human embryos, researchers have called for a moratorium on the use of the technology in reproductive cells. MOLEKUUL/SCIENCE PHOTO LIBRARY The gene-editing technique CRISPR uses an enzyme (white) and RNA guides (blue) to cut DNA at a point specified by a DNA fragment (red). In a Comment published on 12 March in Nature1, Edward Lanphier, chairman of the Alliance for Regenerative Medicine in Washington DC, and four co-authors call on scientists to agree not to modify human embryos even for research. Such research could be exploited for non-therapeutic modifications. We are concerned that a public outcry about such an ethical breach could hinder a promising area of therapeutic development, write Lanphier and his colleagues, who include Fyodor Urnov, a pioneer in gene-editing techniques and scientist at Sangamo BioSciences in Richmond, California. Many groups, including Urnov's company, are already using gene-editing tools to develop therapies that correct genetic defects in people (such as by editing white blood cells). They fear that attempts to produce designer babies by applying the methods to embryos will create a backlash against all use of the technology. Known as germline modification, edits … Continue reading →

IMAGE:The new test uses endothelial cells grown from stem cells in the blood. This image shows these cells stained with fluorescent markers. view more Credit: Imperial College London Scientists at Imperial College London have developed a test that uses combinations of cells from a single donor's blood to predict whether a new drug will cause a severe immune reaction in humans. The test could avert disasters like the 2006 trial of the drug TGN1412, which led to six healthy young men being admitted to intensive care with multiple organ failure. The volunteers receiving TGN1412 experienced a catastrophic inflammatory reaction called a cytokine storm. Cytokine storm reactions are a particular worry for new biological therapies, or "biologics", which use biological material such as antibodies. Many blockbuster drugs such as the cancer drugs Herceptin and Avastin are biologics, as are around a third of medicines in the pharmaceutical pipeline. Because these medicines are specific to humans, they can cause severe reactions that don't materialise in animal studies, so tests on human cells are essential. However, cytokine storm side effects are hard to predict with tests were just one cell type is used, since they depend on interactions between blood cells and endothelial … Continue reading →

San Bruno, CA. (PRWEB) March 04, 2015 PRC Clinical, a full-service, Contract Research Organization (CRO) headquartered in the San Francisco Bay Area, will exhibit and present at the Outsourcing in Clinical Trials (OCT) Israel Conference 2015 on March 25th and 26th in Tel Aviv, Israel. PRC Clinical seeks to build relationships with Israeli life science companies seeking to conduct U.S. Food and Drug Administration (FDA) clinical trials. The companys services span all phases of human trials, from Phase I studies in healthy subjects, through to Phase II, dose-finding and safety studies to larger Phase III and post-marketing studies. Israel is one of the major emerging markets in terms of healthcare and pharmaceuticals worldwide. According to the Israeli Ministry of Economy, Israel is the fourth largest supplier of pharmaceutical products to the U.S. market. We are familiar with the Israeli and U.S. drug development industry and regulatory requirements, said Tony Taricco, President and Chief Operating Officer at PRC Clinical. We have significant CRO experience conducting trials from early phase through to regulatory submission across a wide range of different therapeutic areas. PRC Clinical will present its clinical services at the event, along with its partner, Statistics & Data Corporation (SDC). SDC … Continue reading →

GETTY/PIC POSED BY MODEL Treatment for the crippling condition is currently limited to basic pain relief or complex joint replacement surgery. But trials using stem cells have shown astonishing results with tissue almost as good as new after just three months. Professor Sue Kimber, who led the research, said: This work represents an important step forward in treating cartilage damage using embryonic stem cells to form new tissue. It may offer a new line of therapy for people with crippling joint pain and we now need this process to be developed for patients. Osteoarthritis occurs when cartilage at the ends of bones wears away causing severe pain and stiffness. Researchers say the latest experiments show the procedure could potentially be a safe and effective treatment for more than eight million people who suffer from jointdamage and inflammation. In the experiments, led by teams at Manchester University and Arthritis Research UK, discarded embryonic stem cells from IVF clinics were transformed into cartilage cells. These were transplanted into rats with defective joints. Tests showed the high-quality artificially grown tissue quickly aided the repair of the joint. Read the original here: Arthritis cure is on the way: Scientists make new breakthrough using embryonic … Continue reading →