Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair

The secondary purpose of this research project is to evaluate whether transplanted Schwann
cells can enhance recovery of sensory and motor function. Emergency expanded access for a
single patient was granted, as the patient was an ideal candidate for sural nerve repair
augmented by autologous Schwann cells which could be harvested either from a relatively small
segment of sensory nerve or as in this case from local debridement of injured nerve at the
epicenter of the nerve injury. The cells were expanded using cell culture techniques and
placed along with the sural nerve grafts wrapped by an FDA approved collagen matrix
(Duragen). This study is being conducted at the Jackson Memorial and the University of Miami
health systems. As a research subject the patient will be in this study for a total of 5
years from the date receiving Schwann cell transplant augmentation of sural nerve autografts.

- single patient with severe sciatic nerve injury enrolled under emergency request