Search Results for: hans keirstead spinal cord injury

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 →

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 →