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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Nerve Injury
• Intervention / Treatment: Biological: Autologous Human Schwann Cell

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: George Jimsheleishvilli, MD; Phone Number: (305) 2434781; Email: gxj150@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: George Jimsheleishvilli, MD; Phone Number: (305) 2434781; Email: gxj150@med.miami.edu
      • Principal Investigator: Allan Levi, MD
      • Sub-Investigator: S. Shelby Burks, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous Human Schwann Cell (ahSC) Group; Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-related Adverse Events (AEs)	Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Recovery as assessed using the MRC Grading Scale	Motor recovery will be assessed using the Medical Research Council (MRC) Grading Scales. MRC Grading Scale scores ranges from 0-5 with a higher score indicating better function	Up to 2 years
Sensory recovery as assessed by Pin-Prick Evaluation	Pin prick evaluation will be assessed using the Semmes Weinstein Monofilament Evaluation. Semmes Weinstein Monofilament evaluation has a total score ranging from 0-5 with a higher score indicating better function	Up to 2 years
Sensory recovery as assessed by the 2-Point Discrimination Evaluation	2-Point Discrimination Evaluation scoring ranges from 2-20mm with a higher score indicating worse function	Up to 2 years

Collaborators and Investigators

• Sponsor: W. Dalton Dietrich
• Collaborators: United States Department of Defense
• Investigators: Study Chair: W. Dalton Dietrich, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2026

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: 20220447; OR210075 (Other Grant/Funding Number: United States Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No