Actively Recruiting
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Led by W. Dalton Dietrich · Updated on 2025-09-02
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
W. Dalton Dietrich
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on people who have experienced severe injuries to major nerves, such as the sciatic nerve, brachial plexus, or other major nerves in the arms or legs within the past year. It aims to study the safety and potential risks of using a person's own Schwann cells combined with a nerve auto-graft to help repair these injuries. The study is a Phase 1 clinical trial led by W. Dalton Dietrich to explore this treatment approach for peripheral nerve injury. Participants will undergo a sural nerve biopsy, where a small piece of nerve is taken from the leg. From this sample, a one-time dose of 80 to 100 million autologous human Schwann cells (ahSC) will be prepared and transplanted to the injury site. This biological treatment is being studied to observe how it affects nerve recovery and any possible side effects. During up to two years of follow-up, researchers will monitor participants for treatment-related adverse events and assess motor and sensory recovery using established scales such as the MRC grading scale, pin-prick evaluation, and two-point discrimination tests. Participants will have regular evaluations to track their progress and safety throughout the study period.
CONDITIONS
Brief Title
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year
- Between the ages of 18 and 65 at last birthday
You will not qualify if you...
- Persons unable to safely undergo an MRI
- Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest
- Persons with severe peripheral nerve injury gap length > 10 cm
- 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 enrollment
- 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
- Persons unable to provide consent independently due to cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - One-time procedure with follow-up for up to 2 years
Participants undergo a sural nerve biopsy followed by a one-time transplant of Autologous Human Schwann Cells (ahSC).
Approximately 6 post-operative visits
Duration - Up to 2 years
Participants are monitored for safety and recovery including motor and sensory assessments for up to 2 years after treatment.
Regular visits for assessments over 2 years
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
G
George Jimsheleishvilli, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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