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| Name | Class |
|---|---|
| The Miami Project to Cure Paralysis | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous human Schwann cells | Experimental | All participants will receive autologous human Schwann cells harvested from their own sural nerve. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous human Schwann cells | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to 5 years |
| Sensory recovery scale grade of affected dermatomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allan Levi, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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). | 2 years post-transplantation |
Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury. |
| 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. | 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. | from baseline to 5 months post-transplantation |
| Nerve-graft continuity | Ultrasound will be used to assess nerve-graft continuity. | 2 weeks post-transplantation |
| D014947 | Wounds and Injuries |