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Schwann Cell Clinical Trial for Chronic Spinal Cord Injury

This trial is an FDA-approved Phase I clinical trial designed to test the safety of autologous human Schwann cells in participants with chronic spinal cord injury receiving rehabilitation.   Some, but not all, of the Inclusion and Exclusion Criteria are listed below.

Subject inclusion criteria:
  • Persons with traumatic spinal cord injury (SCI) that occurred a minimum of 12 months prior to enrollment;
  • Between the ages of 18 and 65 years at last birthday;
  • SCI between cervical level C5 and thoracic level T12 as defined by the most caudal level of intact motor and sensory function on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI);
  • ASIA Impairment Scale (AIS) grade A, B, or C at time of enrollment;
  • Spinal cord lesion size that is less than or equal to 3 cm in length and less than or equal to 2 cc in volume when viewed on MRI
Subject exclusion criteria (not all are listed here):
  • Persons with penetrating injury of the spinal cord or complete transection of the cord, as identified by MRI;
  • Persons with a cavity structure that would preclude successful transplantation, as identified by MRI;
  • Intolerance to functional electrical stimulation of muscles;
  • Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
  • Body Mass Index (BMI) > 35;
  • Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest
Cohort 1: Thoracic Injuries with Grades A, B, C

We will enroll up to 4 participants who have thoracic spinal cord injuries between the levels of T2 to T12 with Grades A, B, or C in cohort 1.

We will enroll 2 participants with Grade A injuries before we enroll any participants with Grades B or C injuries.

Cohort 2: Cervical Injuries with Grades A, B, C

We will enroll up to 6 participants with cervical spinal cord injuries between the levels of C5 to T1 with Grades A, B or C in cohort 2.

We will enroll 2 participants with Grade A injuries before we enroll any participants with Grades B or C injuries.

 

For more information regarding these studies, please call The Miami Project’s Education Department at (305) 243-7108.