FDA Approves Spinal-Cord Injury Therapy using Patient’s Own Cells

 

 

 

 

By Dave Andrusko

Dr. David Prentice

ABC News’s Susan Donaldson James reported yesterday that the FDA has approved a phase 1 clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with paralysis-the first such trial in the world.

NRL News Today asked Dr. David Prentice, an expert on stem cells, what this all means. We began by asking him what “Schwann cells” are.

“Schwann cells are ‘nurse’ cells in the body, acting as a sheath around large nerves to protect and nurture them,” he said. In the trial patients will have some of their Schwann cells removed by a biopsy procedure from a nerve in their leg.

“Those cells will be grown in number and purified in the lab over a period of weeks before being transplanted into the site of spinal cord injury to stimulate repair of spinal cord damage,” Dr. Prentice explained. While this is primarily a safety trial, “there is the hope that the Schwann cells will also stimulate repair of the spinal cord,” Dr. Prentice said.

The trial, he said, “is another exciting advance for non-embryonic stem cell treatments.”

The focus of Susan Donaldson James’ story is Marc Buoniconti, son of hall of fame football player Nick Buoniconti. 27 years ago Marc was paralyzed from the neck down after sustaining a football injury.

Along with his father, Marc has become the public face of “The Miami Project,” which has done yeoman work in publicizing spinal cord injuries and seeking a cure.

Neurosurgeon Dr. Barth Green, co-founder and chairman of The Miami Project, said,  “We believe today’s announcement is just as important to our field as man’s first step on the moon was to the space program.” Marc Buoniconti added, “I am more optimistic now than I have ever been before.”

ABC News reported that “eight patients with acute spinal-cord injuries, or those within one month of paralysis, will be injected with their own Schwann cells as scientists at the University of Miami Medical Center monitor them for side effects.”

Dr. Prentice explained that this technique is similar in some respects to the adult stem cell technique that has been used by Dr. Carlos Lima of Portugal and his colleagues.

“In their trials, they transplant the patient’s own olfactory (nasal) tissue containing adult stem cells into the damaged area of the spinal cord,” he said. “Over a period of several years they have documented in scientific publications the significant improvements in spinal cord injury patients after the adult stem cell treatment.”