Using patients' own Schwann cells to improve recovery from severe nerve injuries
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
This study is testing if using patients' own Schwann cells along with nerve grafts can help people with severe nerve injuries recover better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05541250 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have experienced severe sciatic or brachial plexus nerve injuries within the past year.
Not a fit: Patients with severe nerve injury gaps greater than 10 cm or those with certain pre-existing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with severe peripheral nerve injuries.
How similar studies have performed: While this approach is innovative, similar studies involving Schwann cell therapies have shown promise in nerve regeneration, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: George Jimsheleishvilli, MD
- Email: gxj150@med.miami.edu
- Phone: (305) 2434781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.