Peripheral Nerve Injuries
Conditions
Brief summary
Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).
Interventions
BIOLOGICALAutologous Human Schwann Cells
Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix
Sponsors
W. Dalton Dietrich
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 16 Years
Inclusion criteria
* Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year; * Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;
Exclusion criteria
* Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety); * Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve); * Persons with severe peripheral nerve injury gap length \> 10 cm in length; * Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve; * Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation; * Presence of disease that might interfere with participant
Countries
United States
Outcome results
None listed