By Susan Brinkmann, OCDS
Staff Journalist
The first human trial involving embryonic stem cells (ESC) has officially begun with the injection of a partially paralyzed patient with millions of stem cells in an Atlanta hospital.
The trial, conducted by Geron Corporation of Menlo Park, California, and authorized by the Food and Drug Administration, will include ten patients and take place in seven sites across the country. The patients will be injected with about two million “oligodendrocyte progenitor cells,” created from embryonic stem cells, in the hopes the cells will form a restorative coating around the damaged spinal cord.
The first injection took place at the Shepherd Center in Atlanta, a hospital that specializes in spinal cord and brain injuries. The patient, whose identity has not been disclosed, received an injection directly into the site of the damage. Doctors will now conduct a series of specially designed tests to see whether the treatment helps and if it will restore sensation and/or lost mobility in patients.
“If we were able to do that, it would be a phenomenally positive result,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO.
Proponents of ESC research see this as a giant leap forward, but even supporters are concerned that the Geron trials are premature and could risk complete disaster for the field if anything goes wrong – which it has more often than not in the laboratory.
“We desperately need to know how these cells are going to perform in the human setting,” said John Gearhart, a stem cell pioneer at the University of Pennsylvania to the Washington Post. “But are we transplanting cells that are going to cause tumors? Will they will stay where you put them and do what you want them to do?”
Concerns about the readiness of the treatment for human trials has already caused the FDA to delay the start of the testing once, with many scientists still concerned that Geron is going too fast and risking too much.
Evan Snyder, a neuroscientist who heads up the stem cell research center at the Burnham Institute for Medical Research in San Diego, told Life News last fall that he doesn’t believe the research is ready.
“There’s a lot of debate among spinal cord researchers that the pre-clinical data itself doesn’t justify the clinical trial,” Snyder said, indicating that he would have preferred to see Geron conduct experiments on larger animals before testing the treatment on humans.
“There’s a lot of angst around these trials,” said Evan Y. Snyder, director of the stem cell program at the Sanford-Burnham Medical Research Institute in San Diego to the Post. “There’s going to be this perception that if the cells do not perform well, the entire field will be illegitimate.”
This is especially true as the issue of federal funding is for the controversial research is being deliberated in federal court. If patients are hurt during these trials, or if ESC don’t appear to be of much help, this could be an even more devastating blow to the scientists involved in what has thus far been disappointing research.
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