Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)

Recruiting now · Phase 1

Conditions studied: Peripheral Nerve Injury

In brief

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 facts

Study ID

NCT05541250

Run by

W. Dalton Dietrich

People needed

30

Starts

2023-05-04

Expected to finish

2026-09-29

Last updated by the study team

2025-09-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• University of Miami — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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