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

Phase 1

Recruiting

• Conditions: Peripheral Nerve Injury
• Interventions: Biological: Autologous Human Schwann Cell

• Registration Number: NCT05541250
• Lead Sponsor: W. Dalton Dietrich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-15
• Study Start: 2023-05-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-09-29
• Study Completion: 2026-09-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Human Schwann Cell (ahSC) Group	Autologous Human Schwann Cell	Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Motor Recovery as assessed using the MRC Grading Scale	Up to 2 years	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
Sensory recovery as assessed by Pin-Prick Evaluation	Up to 2 years	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
Sensory recovery as assessed by the 2-Point Discrimination Evaluation	Up to 2 years	2-Point Discrimination Evaluation scoring ranges from 2-20mm with a higher score indicating worse function

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States