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 Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
5
Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix
University of Miami
Miami, Florida, United States
Number of participants with reported adverse events (AEs)
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.
Time frame: 12 months post-transplantation
Number of participants with reported cell product culture test failure
Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.
Time frame: 12 months post-transplantation
Change in muscle strength scale grade of affected limb muscles
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.
Time frame: from baseline to 12 months post-transplantation
Sensory recovery scale grade of affected dermatomes
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Time frame: from baseline to 12 months post-transplantation
Change in pain scores
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.
Time frame: from baseline to 12 months post-transplantation
Change in pain characteristics (location, intensity, and description)
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.
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Time frame: from baseline to 12 months post-transplantation
Number of participants with reported tumorigenesis or unexpected changes in nerve structure
Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).
Time frame: 2 years post-transplantation
Change in muscle strength scale grade of affected limb muscles
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.
Time frame: from baseline to 5 years
Sensory recovery scale grade of affected dermatomes
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
Time frame: from baseline to 5 years
Change in pain scores
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.
Time frame: from baseline to 5 years post-transplantation
Change in pain characteristics (location, intensity, and description)
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.
Time frame: from baseline to 5 months post-transplantation
Nerve-graft continuity
Ultrasound will be used to assess nerve-graft continuity.
Time frame: 2 weeks post-transplantation