Autologous Human Schwann Cells in Peripheral Nerve Repair

NCT03999424 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 20190453
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.

Conditions

Peripheral Nerve Injuries

Outcome Measures

Primary Outcomes (7)

• Number of participants with reported adverse events (AEs)

  The number of participants with reported AEs will be evaluated to assess safety. Using CTCAE v4.0 grading scale, all AEs that are Grade 3 or higher with treating physician's attribution of probable or definite relation to intervention will be included.

  12 months post-transplantation

• Number of participants with reported cell product culture test failure

  Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.

  12 months post-transplantation

• Change in muscle strength scale grade of affected limb muscles

  The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.

  from baseline to 12 months post-transplantation

• Sensory recovery scale grade of affected dermatomes

  Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.

  from baseline to 12 months post-transplantation

• Change in pain scores

  The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.

  from baseline to 12 months post-transplantation

• Change in pain characteristics (location, intensity, and description)

  Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.

  from baseline to 12 months post-transplantation

• Number of participants with reported tumorigenesis or unexpected changes in nerve structure

  Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).

  2 years post-transplantation

Secondary Outcomes (5)

• Change in muscle strength scale grade of affected limb muscles

  from baseline to 5 years

• Sensory recovery scale grade of affected dermatomes

  from baseline to 5 years

• Change in pain scores

  from baseline to 5 years post-transplantation

• Change in pain characteristics (location, intensity, and description)

  from baseline to 5 months post-transplantation

• Nerve-graft continuity

  2 weeks post-transplantation

Study Arms (1)

Autologous human Schwann cells

EXPERIMENTAL

All participants will receive autologous human Schwann cells harvested from their own sural nerve.

Biological: autologous human Schwann cells

Interventions

autologous human Schwann cells BIOLOGICAL

Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix

Autologous human Schwann cells

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 injury at the upper or lower extremity with nerve loss within previous year;
• Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;
• Between the ages of 18 and 65 years at last birthday;

You may not qualify if:

• Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
• Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
• Persons with severe peripheral nerve injury gap length \> 10 cm in length;
• 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 transplantation;
• 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;

Sponsors & Collaborators

• W. Dalton Dietrich: lead
• The Miami Project to Cure Paralysis: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

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

• Allan Levi, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: September 24, 2019
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)