Recruiting
Phase 1

ahSC

Sponsor:

W. Dalton Dietrich

Code:

NCT05541250

Conditions

Peripheral Nerve Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Autologous Human Schwann Cell

Study Details

Brief 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.

Conditions

Peripheral Nerve Injury

Study ID

NCT05541250

Start date

May 4, 2023

Status verified date

Aug, 2026

Completion date

Sep 29, 2026

Anticipated

Primary completion date

Sep 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
2. Between the ages of 18 and 65 at last birthday

Exclusion Criteria:

1. Persons unable to safely undergo an MRI;
2. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
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, including primary tumors of the nerve;
5. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
6. Presence of disease that might interfere with participant safety, compliance, or evaluation 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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Autologous Human Schwann Cell (ahSC) Group

Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant

Interventions

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.

Primary outcome measure

  • Incidence of Treatment-related Adverse Events (AEs) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

George Jimsheleishvilli, MD

(305) 2434781gxj150@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

George Jimsheleishvilli, MD

(305) 2434781gxj150@med.miami.edu

Principal Investigator:

Allan Levi, MD

More Information

Sponsor

W. Dalton Dietrich

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by W. Dalton Dietrich on 2026-08-14.