Miami Project Human Trials

Reprinted from PN October 2012

Clinical trials to evaluate safety of transplanting human Schwann cells to treat patients with recent spinal-cord injuries.

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Human testing is set to begin in a revolutionary clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal-cord injuries (SCI).

The Miami Project to Cure Paralysis in Florida has received permission from the Food and Drug Administration to begin a Phase I clinical trial on the cells.

Found mainly in the peripheral nervous system, Schwann cells are essential to sending appropriate electrical signals through the nervous system, and Miami Project scientists believe they are key to finding cures for paralysis.

Investigators plan to transplant a patient’s own Schwann cells at the injury site in the hope of ascertaining safety that will allow further trials to proceed.

The clinical trial will enroll eight participants with an acute thoracic SCI within five days of their injury. At that point, each participant will undergo a biopsy of a sensory nerve in one leg to obtain his or her own Schwann cells.

The cells will then be grown in a culturing facility for three to five weeks to generate the number of cells necessary for transplantation, and to undergo the strict purification process. By the time the Schwann cells are surgically transplanted into the injury site, participants will be 26–40 days post-injury.

Each participant will be followed intensely for one year after receiving the transplantation surgery.

It could be at least two to three years from the time the first subject is enrolled until the final subject is one year post-transplantation. All participants will continue to be monitored for years under a separate clinical protocol.

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Miami Project Human Trials


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