Peripheral Nerve Injury
Conditions
Brief summary
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.
Interventions
BIOLOGICALAutologous Human Schwann Cell
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.
Sponsors
W. Dalton Dietrich
United States Department of Defense
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year; 2. Between the ages of 18 and 65 at last birthday
Exclusion criteria
1. Persons unable to safely undergo an MRI; 2. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest; 3. Persons with severe peripheral nerve injury gap length \> 10 cm; 4. Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve; 5. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment; 6. Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study; 7. History of active substance abuse; 8. Persons allergic to gentamicin; 9. Persons who test positive for HIV or Hepatitis B or C virus. 10. Persons unable to provide consent independently due to cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-related Adverse Events (AEs) | Up to 2 years | Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor Recovery as assessed using the MRC Grading Scale | Up to 2 years | 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 |
| Sensory recovery as assessed by Pin-Prick Evaluation | Up to 2 years | 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 |
| Sensory recovery as assessed by the 2-Point Discrimination Evaluation | Up to 2 years | 2-Point Discrimination Evaluation scoring ranges from 2-20mm with a higher score indicating worse function |
Countries
United States
Contacts
CONTACTGeorge Jimsheleishvilli, MD
STUDY_CHAIRW. Dalton Dietrich, MD
University of Miami
Outcome results
None listed