Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC)
augmentation of nerve autograft repair in participants with severe peripheral nerve injury
(PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve
autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and
thus improve functional recovery.
Phase
Phase 1
Funding Agency/Sponsor
Other
Disease
Trauma
Enrollment Eligibility
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;
- Between the ages of 18 and 65 years at last birthday;
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 safety, compliance, or
evaluation of the condition under study;
- History of active substance abuse;
- Persons allergic to gentamicin;
- Persons who test positive for HIV or Hepatitis B or C virus;