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

Phase 1RecruitingNCT05541250

W. Dalton Dietrich30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Peripheral Nerve Injury

Interventions

Autologous Human Schwann CellBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of Treatment-related Adverse Events (AEs)

Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician

Time frame: Up to 2 years

Secondary Outcomes

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

Time frame: Up to 2 years

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

Time frame: Up to 2 years

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

Time frame: Up to 2 years

Central Contacts

George Jimsheleishvilli, MD

CONTACT

(305) 2434781 gxj150@med.miami.edu

Data from ClinicalTrials.gov

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