The first ever patient to receive treatment in a U.S. government approved study involving human embryonic stem cells has been injected with millions of the potentially life saving cells. He is presently being treated at the Shepherd Center in Atlanta. He was partially paralyzed following a spinal cord injury. The center specializes in treating these types of injuries.
The trial protocol states that patients must receive the stem cell injection within 14 days of the injury and it includes only patients with spinal cord injuries.
Susan L. Solomon, CEO of the New York Stem Cell Foundation said, “We've known about this for a long time, we've been waiting for it to happen and we hope it goes well. Definitely it's a step forward.” Paul Sanberg, professor of neurosurgery and director of the University of South Florida Center for Aging and Brain Repair in Tampa also said, “Clearly this bodes well, in the sense of getting stem cells to the clinic, especially in spinal cord injury. This is a safety study, and once that continues, hopefully there will be good efficacy.”
There is also a lot of skepticism around the trial say experts. Evan Y. Snyder, director of the stem cell program at the Sanford-Burnham Medical Research Institute in San Diego said, “There's a lot of angst around these trials…There's going to be this perception that if the cells do not perform well, the entire field will be illegitimate.”
Stem cells are to benefit patients with spinal cord injuries, Alzheimer's disease, Parkinson's and diabetes in the near future say scientists.
This is the first trial of its kind, a Phase I trial, sponsored by Geron Corp. of Menlo Park, Calif. If all goes well, later trials will assess the strategy's effectiveness. This Monday Geron President and CEO Dr. Thomas B. Okarma said that “initiating this clinical trial is a milestone for the field of human embryonic stem cell-based therapies.” Northwestern Medicine in Chicago is also enrolling patients for a similar trial. There will be a total of seven sites for the trial.
Embryonic stem cell therapy has garnered a lot of controversy. President George W. Bush's administration banned federal funding for research using newly created embryonic stem cells, citing ethical concerns that these cells represented viable human life. That ban was overturned by the Obama administration. However in late August U.S. District Court Judge Royce Lamberth ruled that federal funding of embryonic stem cell research did violate a 1996 law prohibiting the use of taxpayer dollars for such work. The Obama administration appealed that decision.
Dr. Richard Fessler of Northwestern University and Northwestern Memorial Hospital, who is leading the trial said, “I think it's likely that 50 percent or even 75 percent of patients we evaluate will not meet the criteria [for the trial]… What will happen is some individuals will experience some kind of spinal cord injury…” If the injury is the right kind -- the spine is crushed but not severed, the patient does not have an infection or a history of cancer and if the injury occurs in the right spot in the middle of the back -- the patient's doctor might recommend they be included in the trial he said. Patients offered a chance to be in the trial have only 11 days from the time of their injury to decide, Fessler said. “We have to transplant them within 14 days of the injury…We have three days of preoperative testing we have to do before we can do the transplant. They have to be given the offer and make their decision by day 11,” he explained.
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