Embryonic Stem Cell Therapy Data Submitted – UCI Irvine Waiting for FDA to Approve For Treatment of Patients with Spinal Cord Da
Posted Nov 10 2009 10:01pm
The rats are doing well and the article states that the walking ability was restored to 97 percent. This could hold some real big answers to those who have spinal cord damages and being able to function without paralysis of the limbs. Geron was one of the first companies given the go ahead for developing embryonic stem cell use.
Geron will treat a small group of spinal-cord injury patients using neurons derived from stem cells once the FDA gives the go ahead and determines the data submitted is sufficient to begin the use with testing embryonic stem cells with human patients. BD
ScienceDaily (Nov. 9, 2009) — The first human embryonic stem cell treatment approved by the FDA for human testing has been shown to restore limb function in rats with neck spinal cord injuries -- a finding that could expand the clinical trial to include people with cervical damage.
In January, the U.S. Food & Drug Administration gave Geron Corp. of Menlo Park, Calif., permission to test the UC Irvine treatment in individuals with thoracic spinal cord injuries, which occur below the neck. However, trying it in those with cervical damage wasn't approved because preclinical testing with rats hadn't been completed.
Results of the cervical study currently appear online in the journal Stem Cells. UCI scientist Hans Keirstead hopes the data will prompt the FDA to authorize clinical testing of the treatment in people with both types of spinal cord damage. About 52 percent of spinal cord injuries are cervical and 48 percent thoracic.
A week after test rats with 100 percent walking ability suffered neck spinal cord injuries, some received the stem cell treatment. The walking ability of those that didn't degraded to 38 percent. Treated rats' ability, however, was restored to 97 percent.
UCI's therapy utilizes human embryonic stem cells destined to become spinal cord cells called oligodendrocytes. These are the building blocks of myelin, the biological insulation for nerve fibers that's critical to proper functioning of the central nervous system. When myelin is stripped away through injury or disease, paralysis can occur.
Lead author and doctoral student Jason Sharp, Keirstead and colleagues discovered that the stem cells not only rebuilt myelin but prevented tissue death and triggered nerve fiber regrowth. They also suppressed the immune response, causing an increase in anti-inflammatory molecules.