Stem Cells for ALS: Inside a Clinical Trial
ALS Patient Volunteers for Stem Cell Transplants Into Spinal Cord
Stem Cells for ALS continued...
Type those words into an Internet search engine and you'll find dozens of clinics offering stem cell cures for nearly every chronic disease on earth, including ALS. Some shady clinics profit from the hopes raised by the central role of stem cells in regenerative medicine. Real stem cell research, however, is moving at the slower pace that science demands.
"People travel around the world to get 'stem cell' treatment," Glass says. "So unless we prove it works or it doesn't, people with no other options will pay large sums to get this. And that is wrong."
Glass suspects that the nerve wasting in ALS involves an unhealthy environment in the tissues surrounding nerve cells. Part of that unhealthy environment may be the excess of a DNA building block, glutamate, in the brains and spinal cords of ALS patients. Another part may be that cell signals supporting nerve health may be lost.
Neural stem cells -- stem cells committed to becoming part of the nervous system but still able to become different kinds of nerve cells -- might be the answer. These stem cells produce a "glutamate transporter" that carts off excess amino acid. And they also emit growth signals supporting nerve growth.
"These stem cells, I believe, are nurse cells," Glass says. "They are going to create the needed cells that are going to be supportive to the motor neurons."
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.