FDA OKs spinal cord injury stem cell trial for Asterias
- The FDA has given Menlo Park, CA-based Asterias Biotherapeutics the go-ahead to launch a 13-person safety study using oligodendrocyte progenitor cells (OPCs), which are derived from embryonic stem cells.
- The experimental stem cell treatment aims to help patients with severe spinal cord injuries regain nerve function in the affected areas and, hopefully, regain some motility.
- Asterias is slated to receive a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM). The safety study is expected to begin enrolling patients early next year.
This approval is more than four years in the making, as San Francisco Business Journal reports. CIRM had already struck a deal with another CA-based company, Geron Corp., to conduct a pioneering (if controversial) stem cell therapy trial in human patients. Strikingly, four out of the five patients treated with the Geron stem cell therapy reported improvement later on -- but it is unclear how much of that was attributable to the treatment.
Geron never quite got a chance to find out, as the company canceled nixed the trials as part of budget cuts in 2011. However, one Geron executive, Michael West, struck a deal with Asterios to continue the testing with several of the stem cell lines. Unlike the Gerson study, Asterios' trial will involve far stronger doses of OPCs and will be used on patients whose injuries stem from the neck, rather than the back.
- San Francisco Business Times Stem cell trial for spinal cord injuries cleared by FDA