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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Nerve Injury

Intervention / Treatment
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* Biological: Autologous Human Schwann Cell


Participation Criteria
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Eligibility Criteria
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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; Persons who test positive for HIV or Hepatitis B or C virus. Persons unable to provide consent independently due to cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Human Schwann Cell (ahSC) Group<br>Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant | Biological: Autologous Human Schwann Cell<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |