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
177 weeks
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
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.
CONDITIONS
Official 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
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
G
George Jimsheleishvilli, MD
CONTACT
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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