Third Phage Clinical Trial of Stem Cell Center for Spinal Cord Injury Successfully Approved by FDA The stem cell center of General Hospital of Armed Police Forces has successfully passed the second phage clinical trial of stem cell treatment on Spinal Cord Injury which is approved by Food and Drug Association(FDA), and has also obtained the approval of FDA for initiating third phage clinical trial of stem cell treatment on spinal cord injury, which is a landmark indicating that our stem cell center is in international leading role in stem cell treatment field for nervous system diseases. Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control. The disease can greatly affect the health and lifespan of patients. Presently, the treatment for spinal cord injury is mainly rehabilitation treatment, and prevention and treatment for complications such as bedsore, urinary tract infections, respiratory infections, nutrition failure, etc. Traditional treatment can not improve the damaged nerves which are the root of spinal cord injury. Stem cell research, as a heated topic, has attracted wide attention of researchers in the medical field. Starting from 2000, Pro. An Yihua and his team started basic research on stem cell treatment for neurology. In 2003, their team accomplished the experimental research of stem cell treatment on macaque with traumatic brain injury. In 2004, the stem cell treatment center was established as the first one using stem cells for treating central nervous system diseases, including Cerebral Palsy, Spinal Cord Injury, Brain Injury, Stroke, etc. Up to now, this stem cell center has treated 6000 cases of patients from more than 30 countries in the world, among which about 2000 are patients with Spinal Cord Injury. Early on, in 2010, the stem cell center has applied for the clinical trial program of stem cell treatment on central nervous system diseases according to the relevant regulations of WHO and FDA on clinical trials. Up to now, the stem cell center has obtained the approval of WHO for 20 applied clinical trial programs and the approval of FDA for 6 applied clinical trial programs. Among all those programs, phage 1 and phage 2 clinical trials of 11 programs of stem cell treatment on cerebral palsy, spinal cord injury have been accomplished. The clinical trial program of stem cell treatment for spinal cord injury applied in 2012 have all accomplished third phage registration and approval.
Posted on: Mon, 25 Nov 2013 13:51:30 +0000
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