The Safety of ahSC in Chronic SCI With Rehabilitation

Exclusion Criteria

• •1. Persons unable to safely undergo an MRI;
• •2. Persons with penetrating injury of the spinal cord or complete transection of the cord, as identified by MRI;
• •3. Persons with severe, uncorrected post-injury spinal deformity and/or spinal cord inadequately decompressed;
• •4. Persons with a cavity structure that would preclude successful transplantation, as identified by MRI;
• •5. Persons with syringomyelia - defined as patients with progressively enlarging cysts on T2 weighted images with associated neurological decline;
• •6. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
• •7. Intolerance to functional electrical stimulation of muscles;
• •8. Exercise induced abnormalities;
• •9. Range of motion of the upper or lower extremities outside functional limits for targeted fitness and rehabilitation activities;
• •10. Evidence of bone or joint pathology that adversely influences participation in the fitness and rehabilitation activities;
• •11. Fracture, dislocation, or extremity instruments (implanted or external) that adversely influences participation in the fitness and rehabilitation activities;
• •12. Unhealed pressure ulcer;
• •13. History of documented seizures, stroke, brain tumor, serious head injury, or any other intracranial problem that could increase the risk of seizures during motor evoked potentials testing;
• •14. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
• •15. Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
• •16. Body Mass Index (BMI) ≥ 35;
• •17. History of active substance abuse;
• •18. Persons who are current participants in any interventional trial;
• •19. Persons with a history of prior intrathecal or intraspinal cell therapy for SCI;
• •20. Persons allergic to gentamicin;
• •21. Persons who test positive for HIV or Hepatitis B or C virus;
• •22. Persons with lab values significantly outside of the upper and lower limits;
• •23. Persons who can independently ambulate.