RecruitingPhase 1NCT05541250
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Sponsor
W. Dalton Dietrich
Enrollment
30 participants
Start Date
May 4, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria2
- 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
Exclusion Criteria10
- 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
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Interventions
BIOLOGICALAutologous 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05541250
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