Schwann Cell Therapy for Peripheral Nerve Injury

Overseen by Allan Levi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: W. Dalton Dietrich

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Allan Levi, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults aged 18-65 who have had a severe peripheral nerve injury with a gap of 5-10 cm between healthy nerve endings within the last year. It's not suitable for those unable to undergo an MRI, with conditions affecting sural nerve harvest, gaps over 10 cm, local cancer history, pregnant women, or those with certain diseases or substance abuse.

Inclusion Criteria

I have a nerve injury with a gap of 5 to 10 cm between ends.

I am between 18 and 65 years old.

I have had a severe nerve injury in my arm or leg within the last year.

Exclusion Criteria

I do not have any health conditions that could affect my safety or participation in the study.

You have a severe injury to the nerves in your arms or legs that is longer than 10 centimeters.

I have had cancer or radiation in the area where I now have nerve damage.

Treatment Details

Interventions

• Autologous Human Schwann Cells (Cell Therapy)

Trial Overview The study tests whether using one's own Schwann cells (ahSC) to repair damaged nerves can improve healing and function. Participants will receive ahSCs during surgery where their own nerves are used as grafts in areas like the sciatic nerve or brachial plexus.

Participant Groups

Group I: Autologous human Schwann cells Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

W. Dalton Dietrich

Lead Sponsor

Trials

7

Recruited

60+

The Miami Project to Cure Paralysis

Collaborator

Trials

6

Recruited

40+