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Autologous Human Schwann Cells in Peripheral Nerve Repair

NCT03999424 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

BIOLOGICAL

autologous human Schwann cells

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

Sponsors & Collaborators

  • The Miami Project to Cure Paralysis

    collaborator OTHER

  • W. Dalton Dietrich

    lead OTHER

Principal Investigators

  • Allan Levi, MD, PhD · University of Miami

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2025-12-04
Completion
2025-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03999424 on ClinicalTrials.gov