Status:
NO_LONGER_AVAILABLE
Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair
Lead Sponsor:
W. Dalton Dietrich
Conditions:
Peripheral Nerve Injuries
Eligibility:
FEMALE
16-16 years
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04465929
Last Update
July 10 2020
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136