The Safety of ahSC in Chronic SCI With Rehabilitation

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Brief Title

The Safety of ahSC in Chronic SCI With Rehabilitation

Official Title

The Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Chronic Spinal Cord Injury (SCI) Receiving Rehabilitation

Brief Summary

      The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC)
      transplantation in participants with chronic SCI.

      This trial design is phase I, open label, unblinded, non-randomized, and non-placebo
      controlled multiple injury cohorts.
    

Detailed Description

      For humans with chronic SCI, we hypothesize that axons might show improved function if myelin
      repair is induced with the implantation of ahSC. In addition spinal cord cavitation may be
      reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects. In
      this trial, subjects will receive fitness conditioning and rehabilitation prior to
      transplantation in order to validate the stability of their neurological baseline and enhance
      their ability to undergo surgery with few complications. They will also receive fitness
      conditioning and rehabilitation post-transplantation to maintain health and promote neuronal
      activity and potential neuroplasticity.

      Trial enrollment will target 2 cohorts. The first cohort will be thoracic (T) level 2-12 ASIA
      Impairment Scale (AIS) grade A, B, or C (n = up to 4), the second cohort will be cervical (C)
      level 5 through T1 AIS A, B, or C (n = up to 6). Two (2) participants with AIS grade A will
      be enrolled prior to enrolling a participant with AIS B or C, applicable to both cohorts.

      Participants will be monitored throughout a 6 month post-transplantation evaluation period
      for occurrence of AEs (acute, delayed, and/or cumulative), as well as for changes in clinical
      status and neurological status. Safety and efficacy assessments will be performed at weeks 1
      and 2 post-transplantation and months 2 and 6 post-transplantation.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

International Standards of Neurological Classification of Spinal Cord Injury

Secondary Outcome

 Spinal Cord Independence Measure III

Condition

Spinal Cord Injury

Intervention

Autologous human Schwann cells

Study Arms / Comparison Groups

 ahSC transplantation
Description:  Autologous human Schwann cells

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

8

Start Date

January 2015

Completion Date

August 12, 2019

Primary Completion Date

August 12, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Persons with traumatic SCI that occurred a minimum of 12 months prior to enrollment;

          2. Between the ages of 18 and 65 at last birthday;

          3. SCI between spinal levels C5-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);

          4. ASIA Impairment Scale (AIS) grade A, B, or C at time of enrollment;

          5. Lesion length less than or equal to 3 cm and lesion volume less than or equal to 2 cc,
             as approximated by MRI.

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Allan Levi, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02354625

Organization ID

20140846


Responsible Party

Sponsor-Investigator

Study Sponsor

W. Dalton Dietrich

Collaborators

 The Miami Project to Cure Paralysis

Study Sponsor

Allan Levi, MD, PhD, Principal Investigator, University of Miami


Verification Date

August 2019