US FDA OKs First Embryonic Stem Cell Research Trial on Humans, Despite Concerns

Steven Ertelt LifeNews.com 07/31/2010 15:04

The Obama administration has approved the bid by cloning company Geron to undertake the first trial involving the use of embryonic stem cells in humans. They have never been used before in people because the cells cause tumors and have been plagued by immune system rejection issues when tried in animals.

Scientists and pro-life advocates say human embryonic stem cells are not ready for trial because problems associated with the cells in animals haven't been solved.

The Food and Drug Administration had initially placed the trial on hold but Geron indicated today that the agency is now allowing it to proceed with an early stage trial on a stem cell therapy for acute spinal cord injury.

The FDA placed a hold on the trial last August, when evidence showed Geron's GRNOPC1 encountered safety issues when used in animal studies. Geron's own data showed higher frequency of small cysts within the injury site in the spinal cord of animals injected with the embryonic cells.

“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Geron's president, in a public statement today. The company's stock rose in value following the announcement.

Previously, Dr. John A. Kessler, chairman of neurology and director of the stem cell institute at Northwestern University, said the first application from Geron for the embryonic stem cell trial was flawed.

“We really want the best trial to be done for this first trial, and this might not be it,’’ he said at the time.