NCT04465929No Longer AvailableNot Applicable
Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
W. Dalton Dietrich1 site in 1 countryStarted: July 10, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- No Longer Available
- Sponsor
- Locations
- 1
Study Overview
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).
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 16 Years to 16 Years (Child)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Investigators
W. Dalton Dietrich
Professor
University of Miami
Study Sites (1)
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