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

Peripheral Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05541250
• Other study ID #: 20220447
• Secondary ID: OR210075
• Status: Recruiting
• Phase: Phase 1
• Start date: May 4, 2023
• Est. completion date: September 29, 2026

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: George Jimsheleishvilli, MD
• Phone: (305) 2434781
• Email: gxj150[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 29, 2026
• Est. primary completion date: September 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Peripheral Nerve Injury
• Wounds and Injuries

Intervention

Biological:
• Autologous Human Schwann Cell
A one-time dose of 1000 µl* or 80 to 100 million ahSC prepared from segments of the sural nerve from the leg recovered from the participant.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
W. Dalton Dietrich	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-related Adverse Events (AEs)	Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician	Up to 2 years
Secondary	Motor Recovery as assessed using the MRC Grading Scale	Motor recovery will be assessed using the Medical Research Council (MRC) Grading Scales. MRC Grading Scale scores ranges from 0-5 with a higher score indicating better function	Up to 2 years
Secondary	Sensory recovery as assessed by Pin-Prick Evaluation	Pin prick evaluation will be assessed using the Semmes Weinstein Monofilament Evaluation. Semmes Weinstein Monofilament evaluation has a total score ranging from 0-5 with a higher score indicating better function	Up to 2 years
Secondary	Sensory recovery as assessed by the 2-Point Discrimination Evaluation	2-Point Discrimination Evaluation scoring ranges from 2-20mm with a higher score indicating worse function	Up to 2 years