Category Archives: Stem Cell Human Trials

By Rick Nauert PhD Senior News Editor Reviewed by John M. Grohol, Psy.D. on December 9, 2013 Researchers have been on a fast-track to develop drugs to slow or prevent Alzheimers disease. And whilemany of the new compounds appear to work well in animal and cell models, they have all failed in human clinical trials. In a new study, reported online in the journal Stem Cell Reports, researchers provide interesting clues on the failures. In the article, experts suggest why non-steroidal anti-inflammatory drugs (NSAIDs) which have successfully treated molecular signs of Alzheimers disease in cell and animal models eventually failed in clinical studies. They discovered that although the compounds worked in non-neuronal cells lines typically used in pharmaceutical drug screening, human neurons are resistant to this class of drugs. The results of our study are significant for future drug development approaches, because they imply that compound screening and validation studies might be much more reliable if they are conducted using the human cell type affected by the disease in question, said Oliver Brstle who senior-authored the study with colleague Philipp Koch, M.D. Alzheimers disease is the most common cause of dementia among older people, yet there currently are no effective … Continue reading →

Dec. 6, 2013 Why do certain Alzheimer medications work in animal models but not in clinical trials in humans? A research team from the University of Bonn and the biomedical enterprise LIFE & BRAIN GmbH has been able to show that results of established test methods with animal models and cell lines used up until now can hardly be translated to the processes in the human brain. Drug testing should therefore be conducted with human nerve cells, conclude the scientists. The results are published by Cell Press in the journal Stem Cell Reports. In the brains of Alzheimer patients, deposits form that consist essentially of beta-amyloid and are harmful to nerve cells. Scientists are therefore searching for pharmaceutical compounds that prevent the formation of these dangerous aggregates. In animal models, certain non-steroidal anti-inflammatory drugs (NSAIDs) were found to a reduced formation of harmful beta-amyloid variants. Yet, in subsequent clinical studies, these NSAIDs failed to elicit any beneficial effects. "The reasons for these negative results have remained unclear for a long time," says Prof. Dr. Oliver Brstle, Director of the Institute for Reconstructive Neurobiology of the University of Bonn and CEO of LIFE & BRAIN GmbH. "Remarkably, these compounds were never … Continue reading →

Six weeks before the hoopla over President Barack Obama's executive order lifting restrictions on embryonic-stem-cell research, Hans Keirstead, a scientist at the University of California, Irvine, was already sipping champagne. In 2005 Keirstead had published a study showing that a therapy derived from human embryonic stem cells could make partially paralyzed rats walk. Now he'd gotten word that the FDA had cleared the way for Geron, a small biotech company in California, to launch the first clinical trial of the treatment in human beings with spinal-cord injuries. It was incredible news,not just for Keirstead, who'd been wanting to invent a therapy for brain and spinal-cord disorders since he was 11 years old, but for scientists who believe human embryonic stem cells can teach them about complex diseases and potentially lead to cures. Keirstead, 41, and his team of scientists hailed the news over a case of chilled Veuve Clicquot. "We put the last bottle down about six hours later," Keirstead says. "It was just a really fun time." Opinions about the moral status of an embryo won't change with presidential decrees or FDA decisions, so you can bet that the debate over embryonic-stem-cell research is far from over. But no … Continue reading →

Regeneus Limited regeneus.com.au Full Regeneus Limited profile here Regeneus Limited (ASX:RGS) is a regenerative medicine company that develops and commercialises proprietary technologies for the preparation of point-of-care and off-the-shelf cell therapies. Regeneus will fast-track clinical trials and approvals for its human off-the-shelf CryoShot cell therapy to treat osteoarthritis in Japan. Regenerative medicine company Regeneus' (ASX: RGS) will use Japans new laws to fast-track the clinical trial and potential approval of its new human off-the-shelf CryoShot cell therapy to treat osteoarthritis. The Japanese parliament has passed new laws that provide a rapid approval process specifically designed for human stem cell therapies. This provides a significant market opportunity for Regeneus to explore a new accelerated cell therapy approval process in Japan with limited safety and efficacy data. This will be achieved through a separate approval channel for regenerative medicine products that will allow the new cell therapy to be approved for commercial use once limited safety and efficacy data in humans has been demonstrated. Japan, the second largest healthcare market in the world, is setting itself up to be a world leader in regenerative medicine by providing a clear risk-adjusted regulatory framework for swift and safe translation of regenerative medicine research to … Continue reading →

New research has shown human neural stem cells could improve blood flow in critical limb ischemia through the growth of new vessels. Critical limb ischemia (CLI) is a disease that severely obstructs arteries and reduces the blood flow to legs and feet. CLI remains an unmet clinical problem and with an ageing population and the rise in type II diabetes, the incidence of CLI is expected to increase. The study, led by academics in the University of Bristol's School of Clinical Sciences, is published online in the American Heart Association journal Arteriosclerosis, Thrombosis, and Vascular Biology. Current stem cell therapy trials for the treatment of CLI have revitalised new hope for improving symptoms and prolonging life expectancy. However, there are limitations on the use of autologous cell therapy. The patient's own stem cells are generally invasively harvested from bone marrow or require purification from peripheral blood after cytokine stimulation. Other sources contain so few stem cells that ex vivo expansion through lengthy bespoke Good Manufacturing Practice processes is required. Ultimately, these approaches lead to cells of variable quality and potency that are affected by the patient's age and disease status and lead to inconsistent therapeutic outcomes. In order to circumvent … Continue reading →

The landmark trial could one day lead to a breakthrough in the treatment of spinal cord injuries. A patient with spinal cord injury will undergo an experimental therapy using embryonic stem cells for the first time. More participants, who are all severely injured, are expected in the Phase I trial. The ultimate goal is for the treatment to enable patients to eventually recover feeling and movement. Doctors have begun the first tests of human embryonic stem cells in patients, treating a man with spinal cord injuries in a landmark trial of the controversial process, the Geron Corporation said Monday. The patient began the pioneering treatment Friday with an injection of the biotech company's human embryonic stem cells, as part of a clinical trial that aims to test safety and efficacy toward regaining sensation and movement. The treatment took place at the Shepherd Center in Atlanta, Georgia, a spokeswoman for the hospital told AFP, declining to give further details due to patient privacy concerns. The Phase I trial is expected to involve around 10 patients. Participants in the human trials must be severely injured and start treatment with Geron's product, GRNOPC1, seven to 14 days after sustaining their injury. Patients will … Continue reading →

Human Embryonic Stem Cell Clinical Trials[edit] Introduction[edit] The Food and Drug Administration (FDA) approved the first clinical trial in the United States involving human embryonic stem cells on January 23, 2009. Geron Corporation, a biotechnology firm located in Menlo Park, California, originally planned to enroll ten patients suffering from spinal cord injuries to participate in the trial. The company hoped that GRNOPC1, a product derived from human embryonic stem cells, would stimulate nerve growth in patients with debilitating damage to the spinal cord.[1] The trial began in 2010 after being delayed by the FDA because cysts were found on mice injected with these cells, and safety concerns were raised.[2] In the United States, the FDA must approve all clinical trials involving newly developed pharmaceuticals. Researchers must complete an Investigational New Drug (IND) application in order to earn the FDAs approval. IND applications typically include data from animal and toxicology studies in which the drugs safety is tested, drug manufacturing information explaining how and where the drug will be produced, and a detailed research protocol stating who will be included in the study, how the drug will be administered and how participants will be consented.[3] Testing for new drugs must successfully … Continue reading →

healthsection Health Topics A-Z Healthy Living Featured Conditions eHow Now eHow Health Conditions & Treatments Medical Conditions How to Locate Stem Cell Clinical Trials Michele Starkey Michele Starkey is a graduate of the Christian Writers Guild. Her stories have been published by Adams Media, F&W Publications and Thomas Nelson Publishers. After living the world over, she is currently residing in the Hudson Valley of New York and is a reporter for the hometown newspaper. View my portfolio Stem cells are "the building blocks of life that construct blood vessels, the nervous system, organs, and everything else that makes us human," according to the John Hopkins Medical Center (See Reference 1). The U.S. National Institutes of Health and other federal agencies and private industries such as pharmaceutical corporations sponsor a website to assist you in locating clinical trials both within the United States and abroad. (See Reference 2) Participation in stem cell clinical trials requires meeting the criteria outlined in each trial and signing an informed consent form. Visit clinicaltrials.gov, a service provided by the National Institutes of Health in collaboration with other federal agencies, pharmaceutical industries and other private industries. Enter "stem cell" in the search box and receive a … Continue reading →

On January 3, stem cell therapeutics company Advanced Cell Technology (ACT) announced it had received approval from the US Food and Drug Administration to kick off a Phase I/II clinical trial using the company's retinal epithelial cells (RPE). The cells would be used to treat dry age-related macular degeneration (AMD), a progressive vision impairment affecting some 15 million Americans. It's always good news for a company when the FDA clears an investigational new drug application. What made this particular announcement interesting was the source of the biologic agent: ACT would be treating a dozen patients with between 50,000 and 200,000 cells derived from human embryonic stem cells. These cells will be injected into the subretinal space of patients' eyes, where it is hoped they will "restore visual acuity" by activating dormant photoreceptors, says CEO Gary Rabin. Preclinical data, Rabin says, look promising. "In our animal studies, we saw our ability to take rats and mice that were otherwise on their way to being completely blind, and reverse their vision loss to the point that we had restored their visual acuity to 70% that of a healthy animal," he says. The question is, will positive outcomes in animal models translate to … Continue reading →

The Promise of Stem Cells Studying stem cells will help us understand how they transform into the dazzling array of specialized cells that make us what we are. Some of the most serious medical conditions, such as cancer and birth defects, are due to problems that occur somewhere in this process. A better understanding of normal cell development will allow us to understand and perhaps correct the errors that cause these medical conditions. Another potential application of stem cells is making cells and tissues for medical therapies. Today, donated organs and tissues are often used to replace those that are diseased or destroyed. Unfortunately, the number of people needing a transplant far exceeds the number of organs available for transplantation. Pluripotent stem cells offer the possibility of a renewable source of replacement cells and tissues to treat a myriad of diseases, conditions, and disabilities including Parkinson's disease, amyotrophic lateral sclerosis, spinal cord injury, burns, heart disease, diabetes, and arthritis. Scientists have been able to do experiments with human embryonic stem cells (hESC) since 1998, when a group led by Dr. James Thomson at the University of Wisconsin developed a technique to isolate and grow the cells. Although hESCs are thought … Continue reading →