By Cyndi Root International Stem Cell Corporation is now approved to manufacture human parthenogenetic stem cells. The Food and Drug Administration (FDA) cleared the cells for investigational clinical use. The company announced the approval in a press release, stating that it improves its chance for approval of its Parkinsons disease treatment and provides an avenue for using the cells in other indications such as stroke or traumatic brain injury. Dr. Ruslan Semechkin, ISCO's Chief Scientific Officer, said, "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. With this clearance from the FDA, the Company has removed any uncertainty in the potential clinical use of human parthenogenetic stem cells." FDA Action Like all manufacturing to FDA standards, stem cells must be produced in good manufacturing practice (GMP) conditions. The cells must be grown under repeatable conditions and be identical, so that patients receive standardized stem cell therapy. In addition, the federal agency seeks to reduce the risk of an infectious disease. ISCO provided the FDA assurances relating to the original egg donor's risk of infectious diseases, the testing of the master cell bank, and the genetic stability … Continue reading →

McLean Hospital and Harvard Stem Cell Institute scientists have new evidence that stem cell transplantation could be a worthwhile strategy to help epileptics who do not respond to anti-seizure drugs. As reported in Cell Stem Cell, the laboratory of McLean Associate Neurobiologist Sangmi Chung, PhD, transplanted seizure-inhibiting, human embryonic stem cell-derived neurons into the brains of mice with a common form of epilepsy. Half of the mice who received the transplanted neurons no longer had seizures, while the other half experienced a significant drop in seizure frequency. "After the transplantation we observed that the human neurons integrate into the epileptic brain," said Chung, who is also a Harvard Stem Cell Institute affiliated faculty member and an assistant professor at Harvard Medical School. "The transplanted neurons begin to receive excitatory input from host neurons and in turn generate inhibitory responses that reverse the electrical hyperactivity that cause seizures." The recovery seen after the human stem cell-derived neuron transplants, which were done while the cells were still maturing into their full-grown form, is similar to that published in a 2013 study by University of California, San Francisco, scientists who transplanted fetal mouse brain cells into epileptic mice. While encouraging, Chung noted that … Continue reading →