FDA OKs 1st Embryonic Stem Cell Trial
Jan. 24 -- FRIDAY, Jan. 23 (HealthDay News) -- The first human trial using embryonic stem cells as a medical treatment has been approved by the U.S. Food and Drug Administration.
Geron Corp., a California-based biotech company, has been given the OK to implant embryonic stem cells in eight to 10 paraplegic patients who can use their arms but can't walk. Stem cell injections will be given within two weeks of the injury. The study will begin this summer, and will be conducted at up to seven different medical centers.
"This marks the dawn of a new era in medical therapeutics," Dr. Thomas B. Okarma, Geron's president and CEO said during a Friday morning teleconference. "This approach is one that reaches beyond pills and scalpels to achieve a new level of healing."
Ultimately, this type of therapy might have the power to restore permanent organ and tissue function, Okarma said. The goal of this first trial is to see if injecting embryonic stem cells into humans is safe. However, the researchers will also be looking for signs of improvement in the patients' ability to feel sensation in or move their legs.
Patients will receive injections at the site of the injury. It is hoped these cells will mature into cells that will repair damaged nerves and produce chemicals that nerve cells need to function and grow.
This phase I trial will be limited to patients whose injury is located in the middle of the spine. If the trial is successful, Okarma said, the hope is to extend the treatment to patients with cervical spine injuries who are paralyzed from the neck down.
Okarma said the injections must be given early after the injury, before scar tissue has developed that would prevent the cells from growing, but after the initial swelling has subsided.
In addition, patients will receive anti-rejection drugs for about two months, after which they should no longer need those drugs. Patients will be followed for at least one year, he said.
The treatment is not expected to restore full function to patients, but the researchers hope to see modest gains. "Any return of bladder or bowel function, a return of sensation, or a return of lower extremity locomotion would be a very exciting finding," Okarma said.
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