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

NCT05541250 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 20220447OR210075
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Motor Recovery as assessed using the MRC Grading Scale

  Up to 2 years

• Sensory recovery as assessed by Pin-Prick Evaluation

  Up to 2 years

• Sensory recovery as assessed by the 2-Point Discrimination Evaluation

  Up to 2 years

Study Arms (1)

Autologous Human Schwann Cell (ahSC) Group

EXPERIMENTAL

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

Biological: Autologous Human Schwann Cell

Interventions

Autologous Human Schwann Cell BIOLOGICAL

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.

Autologous Human Schwann Cell (ahSC) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• W. Dalton Dietrich: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• W. Dalton Dietrich, MD

  University of Miami

  STUDY CHAIR

Central Study Contacts

George Jimsheleishvilli, MD

CONTACT

(305) 2434781; gxj150@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: May 4, 2023
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)