October, 2013/sfgate.com/–The U.S. Food and Drug Administration last week gave permission to a Newark, N.J., biotech company to start testing an experimental stem cell therapy in humans who have suffered spinal cord injuries – a move that patients and scientists alike hope will speed up research in a field that’s been frustratingly slow to show results.
StemCells Inc. has been testing its neural stem cells in human subjects in Switzerland. So far, seven patients – including one American – have been injected with the stem cells, and preliminary results have been reported on three of them.
The experiment is designed mostly to demonstrate that the stem cell injections are safe.
Next, the company plans a trial aimed at demonstrating that stem cells can improve the lives of patients paralyzed by spinal cord injuries. The trial will be conducted primarily in the United States, but also in Canada.
“The expectation is not that we put these cells into the spinal cord, and the patient jumps out of the wheelchair and starts playing basketball,” said Martin McGlynn, chief executive of StemCells. “If you can have an effect on bowel and bladder function, that would be terrific. If you could get them the use of some fingers, if you could bring the wrist into play or part of the arm, now you’re putting this patient in charge of a wheelchair, now you’re onto something.”
To someone who isn’t paralyzed, it may sound as if McGlynn is aiming low, but, in fact, he said, “our goal is to restore lost function. That’s swinging for the fences.”
Hopes rise and fall
The promise of someday using stem cells to treat spinal cord injuries underscores both the hopes and the frustrations that define the larger field of regenerative medicine.
Actor Christopher Reeve, paralyzed in a horseback riding accident in 1995, was a major early proponent of stem cell research until his death in 2004. The idea of treating spinal cord injuries has long been one of the most public, and publicly scrutinized, areas of stem cell study.
But like the rest of the stem cell field, the spinal cord research has happened in fits and starts. Perhaps most notably, scientists and patients were enthusiastic in 2010 when Menlo Park’s Geron Corp. began the first clinical trial of injecting embryonic stem cells into human patients with spinal cord injuries. That enthusiasm was dashed only a year later, when Geron suddenly and surprisingly stopped the trial and decided to give up on the spinal cord field altogether.
The tides may be changing again, though. Some scientists say they see signs that their peers are on the cusp of success, however limited.
While early trials may have been disappointing, scientists had to expect that “they were not going to be as successful as one would hope,” said Dr. Arnold Kriegstein, director of stem cell research at UCSF. “But as we learn more, and stem cell approaches become more sophisticated, I suspect we will have some real home runs.”
Aside from news about StemCells’ trials starting in the United States, there was positive word last week about the Geron work, too.
Work may begin again
Another Menlo Park company called BioTime announced that it had purchased Geron’s stem cell work and may resume its spinal cord trials. And three or four promising threads of research in other medical companies and institutions are happening in California alone, all involving stem cells injected into or near the damaged spine.
“I’d say there’s a quiet enthusiasm right now,” said Alan Trounson, president of theCalifornia Institute for Regenerative Medicine, the state’s stem cell agency that has financed several spinal cord injury projects. “We’re not really dead sure what it’s going to take yet. But between all of the work going on, I feel like we’re going to find a way to help patients.”
StemCells gets FDA OK on spinal cord trial
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