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RECRUITING
NCT05541250
PHASE1
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Sponsor: W. Dalton Dietrich
View on ClinicalTrials.gov
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-05-04
Completion Date
2026-09-29
Last Updated
2025-09-02
Healthy Volunteers
No
Conditions
Interventions
BIOLOGICAL
Autologous Human Schwann Cell
A one-time dose of 1000 μl\* or 80 to 100 million ahSC prepared from segments of the sural nerve from the leg recovered from the participant.
Locations (1)
University of Miami
Miami, Florida, United States