Tuesday, August 03, 2010
(photo: Ultrafiltrates)
The Food and Drug Administration (FDA) has given the green light to a biotechnology company to conduct the first-ever clinical trial involving human embryonic stem cells (hESC). Geron, based in Menlo Park, California, will test using hESC on patients suffering from severe spinal injuries in the hope the therapy can restore damaged areas of the spinal cord.
FDA officials had put off making a decision about the clinical trial for a year due to safety concerns about using hESC. Geron has spent 15 years and invested $150 million to develop a stem cell-based treatment for spinal patients.
Dr. Richard Fessler, a neurological surgeon at Northwestern University who will lead the study, said the therapy “would be revolutionary” if it’s proven to work. “The therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year,” Fessler told the San Jose Mercury News.
Scientists believe hESC holds the potential to cure numerous medical conditions, due to the ability of embryonic stem cells to turn into any kind of tissue in the human body.
The FDA decision is likely to spark outcry from religious and anti-abortion groups that claim using embryonic stem cells is unethical. The hESC being used by scientists come from 3- to 5-day-old embryos that have been discarded.
-David Wallechinsky
FDA Clears Geron to Start World’s First Trial with hESC Therapy (Genetic Engineering & Biotechnology News)
FDA Approves Geron's Groundbreaking Study of Embryonic Cells (by Steve Johnson, San Jose Mercury News)
Geron’s Embryonic Stem Cell Clinical Trials for Spinal Cord Injury Have Returned (by Aaron Saenz, Singularity Hub)
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