According to Dr. Thomas Okarma, the head of the Geron Corp.’s, if the trials are successful, it will opens the door to new therapies and drug discoveries.
If the trial fails, it could put development of potentially life-saving treatments years away, even if President-elect Barack Obama or the new Democratic Congress reverses a policy to allow federal dollars to boost embryonic stem cell research.
This trial is highly important for the future of embryonic stem cell research, it has put embryonic stem cell research into the judgment sit to prove it’s effectiveness.
It has taken Geron very long time, almost a decade of tireless work to develop a spinal cord treatment. Now, Geron is awaiting the regulatory green light to begin trials in spinal cord patients of its embryonic stem cell-derived drug.
Geron’s researchers used destroyable fertilized embryos that were unused in in-vitro fertilization procedures. Doctors have used adult stem cells for decades in bone marrow transplants for cancer patients, but embryonic stem cells are considered more versatile in the lab.
Geron last year submited an FDA investigational new-drug application, a 22,500-page document. It now sits at FDA’s sprawling headquarters outside Washington.
Because of the complexity of stem cell products, the FDA has taken longer to evaluate Geron’s work before allowing trials to begin in humans.
However, Geron’s embryonic stem cell derived drug is highly successful in animal trials, in a video presentation Geron showed rats with spinal cord injuries that could barely move. Within weeks after they were injected with the stem cell-derived drug known as GRNOPC1, the rodents were seen moving well enough around their cages.