Loading clinical trials...

Autologous Human Schwann Cells in Peripheral Nerve Repair | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Autologous Human Schwann Cells in Peripheral Nerve Repair

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

NCT03999424•W. Dalton Dietrich

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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;

Exclusion Criteria

•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;

Locations (1)

University of Miami

Miami, Florida, United States

Key Dates

Start Date

September 24, 2019

Primary Completion Date

December 4, 2025

Completion Date

December 4, 2025

Last Updated

December 12, 2025

Enrollment

ACTUAL participants

Conditions

Peripheral Nerve Injuries

Interventions

autologous human Schwann cells

BIOLOGICAL

Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

NCT04789044

Peripheral Nerve Injuries

View study

RECRUITINGNA

High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry

NCT07360730

Peripheral Nerve InjuriesNeuroma of Nerve Repair+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Autologous Human Schwann Cells in Peripheral Nerve Repair

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry

Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction

StimRouter Registry Clinical Protocol

Prospective Comparison of Adductor Canal Block Performed With a Multiport Versus Single Bevel Needle

Early Sensory Re-education of the Hand With a Sensor Glove Model