Clinical trial with Schwann Cells in spinal cord injury
The Miami Project to Cure Paralysis has received permission from the FDA to start a Phase 1 clinical trial to evaluate the safety of Schwann Cells transplantation to treat patients with spinal cord injury.
Unlike neurons in the central nervous system, peripheral nerves can regenerate after injury and reconnect to their target cells. Schwann cells, which normally wrap an insulating myelin sheath around the axons of healthy peripheral neurons, boost the survival and regrowth of the nerves after an injury. Therefore they are thought to be an ideal target for boosting regeneration after spinal cord injury.
Starting in 1989 with the work of Dr. Mary Bunge the multidisciplinary Miami Project team has been working for many years on the concept of a therapy for SCI with Schwann cells.
The clinical trial will enrol eight patients with complete thoracic SCI. Recruiting will be done within the first five days after the injury, and after signing an agreement patients will undergo a biopsy of a sensory peripheral nerve to obtain his/her own Schwann cells. These will be purified and cultured for three to five weeks in a GMP (good manufacturing practices) facility to generate the necessary number of cells for (autologous) transplantation.
The patients will then be in a so-called subacute phase, 26 to 40 day after the acute injury, when the cells will be transplanted into the spinal cord. The first year after transplantation the participating patients will be followed and monitored very closely, and on a less frequent interval for additional 4 years. All procedures will be conducted in Miami at University of Miami Hospital, Jackson Memorial Hospital and The Miami Project to Cure Paralysis.