Using patients' own Schwann cells to improve recovery from severe nerve injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of injecting autologous human Schwann cells in conjunction with nerve auto-grafts for patients who have suffered severe peripheral nerve injuries. The study focuses on individuals with significant nerve damage, specifically targeting those with sciatic nerve or brachial plexus injuries. Participants will be monitored for potential harms and overall recovery outcomes following the intervention. The trial aims to determine if this innovative approach can enhance nerve regeneration and functional recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Persons unable to safely undergo an MRI;
2. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
3. Persons with severe peripheral nerve injury gap length \> 10 cm;
4. Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
5. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
6. Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
7. History of active substance abuse;
8. Persons allergic to gentamicin;
9. Persons who test positive for HIV or Hepatitis B or C virus.
10. Persons unable to provide consent independently due to cognitive impairment

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: George Jimsheleishvilli, MD
• Email: gxj150@med.miami.edu
• Phone: (305) 2434781

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.