FDA Approves Stem Cell Study for Spinal Injuries
The FDA approves first human study of stem cell treatment for spinal injuries.
Jan. 23, 2009 — -- The Food and Drug Administration approved the first clinical trial today that will use human embryonic stem cells to potentially draw recent paraplegics out of the wheelchair and back on their feet.
Scientists hope the stem cell therapy will prevent permanent paralysis caused by acute spinal cord injuries and even return feeling and movement in patients who suffered the paralyzing injury two weeks before treatment. The treatment showed positive results when tested in rats.
"In animal models, this restores the animal's ability to walk," Dr. Tom Okarma, president and CEO of Geron Corp., the company putting on the trial, told "Good Morning America" today. "And that's what we hope to achieve in the first trial with patients with spinal cord injury."
A group of eight to 10 paraplegics who still have use of their arms but not legs will be injected with cells derived from embryonic cells, Okarma told The Associated Press.
Although the aim of the study is to test the procedure's safety, doctors will be on the lookout for much more.
"The focus of this trial is safety," Sean Morrison, director at the University of Michigan Center for Stem Cell Biology, told "GMA."
"And if Geron can show it's safe to derive stem cells into patients, that will be an important precedence to enhance future trials for all diseases that could benefit from this work from juvenile diabetes to other types of neurological disorders."
Doctors will also be on the lookout for potentially hazardous side effects. The cells could create benign tumors and there is a danger the patient's immune system could attempt to reject the injections, "thereby increasing the inflammation in the spinal cord instead of decreasing it," Morrison said.
In response, doctors plan to provide the patients with anti-rejection drugs for two months after the initial injection, the AP reported.
If successful, supporters see nearly endless potential for the treatment.
"This is vast," said Peter Kiernan, chairman of the board of directors of the Christopher and Dana Reeve Foundation. "This is like the dawn. It's not a comet across our sky; it's the beginning."
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