Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair
- Conditions
- Peripheral Nerve Injuries
- Registration Number
- NCT04465929
- Lead Sponsor
- W. Dalton Dietrich
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States