Biotech Company gets FDA Approval to Begin Stem Cell Studies
The FDA has given Geron pharmaceuticals the okay to begin stem cell studies this summer. The California biotech company received FDA approval to implant human embryonic cells in eight to ten patients with spinal cord injury, beginning this summer. The studies will be performed at several hospitals throughout the country.
Geron has been anxiously awaiting the go-ahead from the FDA to begin trials using stem cells from humans. In April 2008, Geron attended FDA hearings, submitting their request to begin clinical trials.
Dr. Thomas B. Okarma, president and CEO of Geron says, stem cell research "… is one that reaches beyond pills and scalpels to achieve a new level of healing."
The purpose of the stem cell studies is to determine the safety and see if stem cell therapy actually works. The company plans to inject stem cells directly into the site of spinal cord injury, within 7 to 14 days following injury, using cells derived from embryos. Geron's patented stem cell therapy is called GRNOPC1. The company presented the FDA with 21000 pages that included 24 separate animal studies; documenting how stem cell therapy with GRNOPC1 helped the mice, lead to no ill effects elsewhere in the body, and how stem cells were not recognized as foreign, so there were no problems with adverse immune response.
Geron has plenty of stem cells to support clinical trials. According to their website, "The existing master cell bank could potentially supply sufficient starting material for GRNOPC1 to commercially supply the U.S. acute spinal cord injury market for more than 20 years".
Current methods of harvesting stem cells involve taking the cells from a 4 to 5 day old fertilized egg. The stem cells are then put into a petri dish, afterwards destroying the embryo. The stem cells continue to multiply in the lab petri dish, where they can then be used to develop further into any type of tissue, depending on the need.
Stem cell therapy has been the subject of much controversy. The Catholic Church has called the use of human embryos for stem cell research "immoral". Others believe stem cell therapy is the answer to curing our most difficult diseases. Financial analysts consider the FDA approval of stem cell studies a cause for celebration.