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| ID | Type | Description | Link |
|---|---|---|---|
| OR210075 | Other Grant/Funding Number | United States Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Human Schwann Cell (ahSC) Group | Experimental | Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Human Schwann Cell | Biological | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Jimsheleishvilli, MD | Contact | (305) 2434781 | gxj150@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| W. Dalton Dietrich, MD | University of Miami | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | 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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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 |
| D014947 | Wounds and Injuries |