The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Number of participants with reported tumorigenesis or unexpected changes in nerve structure
Study Overview
Brief Summary
The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year;
- •Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;
- •Between the ages of 18 and 65 years at last birthday;
Exclusion Criteria
- •Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
- •Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
- •Persons with severe peripheral nerve injury gap length > 10 cm in length;
- •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 transplantation;
- •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;
Arms & Interventions
Autologous human Schwann cells
All participants will receive autologous human Schwann cells harvested from their own sural nerve.
Intervention: autologous human Schwann cells (Biological)
Outcomes
Primary Outcomes
Number of participants with reported tumorigenesis or unexpected changes in nerve structure
Time Frame: 2 years post-transplantation
Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).
Number of participants with reported adverse events (AEs)
Time Frame: 12 months post-transplantation
The number of participants with reported AEs will be evaluated to assess safety. Using CTCAE v4.0 grading scale, all AEs that are Grade 3 or higher with treating physician's attribution of probable or definite relation to intervention will be included.
Change in pain scores
Time Frame: from baseline to 12 months post-transplantation
The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.
Change in pain characteristics (location, intensity, and description)
Time Frame: from baseline to 12 months post-transplantation
Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.
Number of participants with reported cell product culture test failure
Time Frame: 12 months post-transplantation
Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.
Change in muscle strength scale grade of affected limb muscles
Time Frame: from baseline to 12 months post-transplantation
The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
Sensory recovery scale grade of affected dermatomes
Time Frame: from baseline to 12 months post-transplantation
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Secondary Outcomes
- Change in pain scores(from baseline to 5 years post-transplantation)
- Nerve-graft continuity(2 weeks post-transplantation)
- Change in muscle strength scale grade of affected limb muscles(from baseline to 5 years)
- Change in pain characteristics (location, intensity, and description)(from baseline to 5 months post-transplantation)
- Sensory recovery scale grade of affected dermatomes(from baseline to 5 years)
Investigators
W. Dalton Dietrich
Professor
University of Miami