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Stem Cells for ALS: Inside a Clinical Trial

ALS Patient Volunteers for Stem Cell Transplants Into Spinal Cord
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Stem Cell Clinical Trial Breaks New Ground

The sponsor of the clinical trial, Neuralstem Inc., has found a way to grow neural stem cells and to freeze them until they are ready for use. University of Michigan researcher Eva Feldman, MD, PhD, had the idea to infuse the cells directly into the spinal cords of ALS patients. She got FDA permission to try it on patients.

This meant asking patients to undergo surgery to remove the bone surrounding their spinal cords. It meant asking them to take immunity-suppressing drugs for the rest of their lives, to prevent rejection of the new cells.

And it meant asking them to do something never before attempted in living people: direct infusion of stem cells into the spinal cord.

Emory's Boulis was the surgeon Feldman entrusted with this job. And Glass' ALS clinic at Emory offered a ready pool of patients and doctors able to participate.

The FDA insisted that they take things one step at a time. Glass feels the agency is being overcautious given that ALS patients already face certain death. The FDA's position is that safety is paramount, and that baby steps are less risky than giant leaps.

The first ALS patients in the trial were on ventilators because they'd already lost the ability to breathe and to walk. They received infusions only on one side of their lower spinal cord. Next came patients able to breathe, followed by patients able to walk. Then both sides of the lower spinal cord were infused. Jerome was one of those latter patients.

But the motor neurons that control breathing -- the ones ALS patients need in order to survive -- are in the upper spinal cord, in the neck. The next step of the study would be to put stem cells not only in the lower spine, but also in the upper spine. The first three patients to undergo this operation would get the cells only on one side of the upper spinal cord.

Jerome volunteered a second time.

"I think of it being like a soldier who has done one tour of duty re-enlisting for a second tour in order to serve his country," Donna Jerome says.

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