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

Last updated: March 24, 2025
Sponsor: W. Dalton Dietrich
Overall Status: Active - Recruiting

Phase

1

Condition

Nerve Injury

Treatment

Autologous Human Schwann Cell

Clinical Study ID

NCT05541250
20220447
OR210075
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerveinjury at the upper or lower extremity within previous year;

  2. Between the ages of 18 and 65 at last birthday

Exclusion

Exclusion Criteria:

  1. Persons unable to safely undergo an MRI;

  2. Persons with pre-existing conditions that would preclude satisfactory sural nerveharvest;

  3. Persons with severe peripheral nerve injury gap length > 10 cm;

  4. Persons with history of radiation or local cancer in area of nerve injury, includingprimary tumors of the nerve;

  5. Pregnant women or a positive pregnancy test in those women with reproductivepotential prior to enrollment;

  6. Presence of disease that might interfere with participant safety, compliance, orevaluation of the condition under study;

  7. History of active substance abuse;

  8. Persons allergic to gentamicin;

  9. Persons who test positive for HIV or Hepatitis B or C virus.

  10. Persons unable to provide consent independently due to cognitive impairment

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Autologous Human Schwann Cell
Phase: 1
Study Start date:
May 04, 2023
Estimated Completion Date:
September 29, 2026

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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