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

NCT05541250 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • W. Dalton Dietrich

    lead OTHER

Principal Investigators

  • W. Dalton Dietrich, MD · University of Miami

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2026-09-29
Completion
2026-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05541250 on ClinicalTrials.gov