FDA Approves Stem Cells For Humans

The Food and Drug Administration has given approval to the cloning company Geron to undertake the world’s first trial of embryonic stem cell-based therapy in humans.

“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 President and Chief Executive Officer. Okarma went on to say that the project aims to treat patients with devastating subacute spinal cord injury by injecting the progenitor embryonic stem cells directly into the lesion site.

“If found to be safe and effective, the [new] therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year,” said Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University.

Other scientists, however, believe the use of embryonic stem cells should not be permitted in humans due to problems associated with these cells in previous animal trials.

“It’s unfortunate that the FDA has released Geron from the safety hold on their embryonic stem cell trial,” said said David Prentice, a former biology professor at Indiana State University, adding that “Even many pro-embryonic stem cell scientists have expressed reservations about Geron’s trial, that it is not proven even in rats. The concern for many of us is that Geron is endangering patient’s health and very lives, to make a political point and increase their stock price.”

“Frankly, I cannot conceive of a human trial with the use of human embryonic stem cells following immediately from experiments in rodents only,” said Jerry Silver, a neuroscience professor and stem-cell researcher at Case Western Reserve University in Cleveland.

He stressed that many treatments fail in humans while they have shown promising results in rodents.

These scientists, hence, consider adult stem cells as the only safe, ethical and successful option for repairing of spinal cord injury.


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