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NCT05541250PHASE1Recruiting

Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)

W. Dalton Dietrich

Start Date

5/4/2023

Completion Date

9/29/2026

Summary

The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: 1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year; 2. Between the ages of 18 and 65 at last birthday Exclusion Criteria: 1. Persons unable to safely undergo an MRI; 2. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest; 3. Persons with severe peripheral nerve injury gap length \> 10 cm; 4. Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve; 5. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment; 6. Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study; 7. History of active substance abuse; 8. Persons allergic to gentamicin; 9. Persons who test positive for HIV or Hepatitis B or C virus. 10. Persons unable to provide consent independently due to cognitive impairment

Interventions

BIOLOGICAL

Autologous Human Schwann Cell

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Conditions

Peripheral Nerve Injury

Locations

University of Miami

Miami, Florida 33136

United States