Headline Patrol: ‘Doctors might have figured out how to cure spinal cord injuries’

We would emphasize that this case series describes an early study on a small number of patients. In addition to being unblinded and uncontrolled, this study has a number of limitations. We cannot rule out observer bias nor a contribution of surgical intervention to recovery in cases where this intervention occurred, or spontaneous recovery.

“We are moving along carefully and cautiously and are trying to minimize ‘hype.’ The approach is quite interesting, but obviously more work is needed and ongoing. We are in the midst of organizing a blinded clinical trial here in the US. Progress has been slowed a bit because of the pandemic, but we have a good clinical group that are working hard to get the study launched.” That trial could take place over the next year, he said.

“This approval is an unfortunate step away from everything researchers have learned over the past 70 years about how to conduct a valid clinical trial.”

…the systemic infusion of MSCs results in functional improvement that is associated with structural changes in the chronically injured spinal cord including stabilization of the BSCB, axonal sprouting/regeneration and remyelination.

The efficacy and safety of the product in patients with AIS D should be investigated in another clinical study.

Kocsis and Waxman stress that additional studies will be needed to confirm the results of this preliminary, unblinded trial. They also stress that this could take years. Despite the challenges, they remain optimistic.

“Similar results with stem cells in patients with stroke increase our confidence that this approach may be clinically useful,” noted Kocsis.

“The idea that we may be able to restore function after injury to the brain and spinal cord using the patient’s own stem cells has intrigued us for years,” Waxman said. “Now we have a hint, in humans, that it may be possible.”

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