RecruitingPhase 1

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

United States30 participantsStarted 2023-05-04

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
. Between the ages of 18 and 65 at last birthday

Exclusion criteria

. Persons unable to safely undergo an MRI;
. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
. Persons with severe peripheral nerve injury gap length \> 10 cm;
. 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 enrollment;
. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-related Adverse Events (AEs)

Timeframe: Up to 2 years

Trial details

NCT IDNCT05541250

SponsorW. Dalton Dietrich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-29

Contact for this trial

George Jimsheleishvilli, MD

(305) 2434781 gxj150@med.miami.edu

View on ClinicalTrials.gov More Peripheral Nerve Injury trials