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The Safety of ahSC in Chronic SCI With Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354625
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
The Miami Project to Cure Paralysis
Information provided by (Responsible Party):
W. Dalton Dietrich, University of Miami

Tracking Information
First Submitted Date  ICMJE January 29, 2015
First Posted Date  ICMJE February 3, 2015
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date August 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • International Standards of Neurological Classification of Spinal Cord Injury [ Time Frame: Change from Baseline at 6 months ]
  • Magnetic Resonance Imaging of spinal cord [ Time Frame: Change from Baseline at 6 months ]
  • Neuropathic Pain Symptoms Inventory [ Time Frame: Change from Baseline at 6 months ]
  • ISCI Basic Pain dataset version2 [ Time Frame: Change from Baseline at 6 months ]
  • Pain Diagram [ Time Frame: Change from Baseline at 6 months ]
  • Quantitative Sensory Testing [ Time Frame: Change from Baseline at 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • Spinal Cord Independence Measure III [ Time Frame: Change from Baseline at 6 months ]
  • SCI-Functional Index Computer Adaptive Testing [ Time Frame: Change from Baseline at 6 months ]
  • 10-Meter Walk Test [ Time Frame: Change from Baseline at 6 months ]
  • 2-Minute Walk Test [ Time Frame: Change from Baseline at 6 months ]
  • Timed Up and Go [ Time Frame: Change from Baseline at 6 months ]
  • Timed Stair Climb [ Time Frame: Change from Baseline at 6 months ]
  • Capabilities of Upper Extremity Questionnaire [ Time Frame: Change from Baseline at 6 months ]
  • ISCI Upper Extremity Basic dataset [ Time Frame: Change from Baseline at 6 months ]
  • ISCI Basic Bowel dataset [ Time Frame: Change from Baseline at 6 months ]
  • ISCI Basic Lower Urinary Tract dataset [ Time Frame: Change from Baseline at 6 months ]
  • ISCI Basic Male and Female Sexual Function datasets [ Time Frame: Change from Baseline at 6 months ]
  • ISCI Quality of Life dataset [ Time Frame: Change from Baseline at 6 months ]
  • Motor Evoked Potentials [ Time Frame: Change from Baseline at 6 months ]
  • Somatosensory Evoked Potentials [ Time Frame: Change from Baseline at 6 months ]
  • Sympathetic Skin Response [ Time Frame: Change from Baseline at 6 months ]
  • Graded Strength Test [ Time Frame: Change from Baseline at 6 months ]
  • 1-Repetition Maximum [ Time Frame: Change from Baseline at 6 months ]
  • Head-up Tilt [ Time Frame: Change from Baseline at 6 months ]
  • Guy Farrar Subject Global Impression of Change [ Time Frame: Change from Baseline at 6 months ]
  • Modified Ashworth Scale [ Time Frame: Change from Baseline at 6 months ]
  • Pendulum Test [ Time Frame: Change from Baseline at 6 months ]
  • Spinal Cord Assessment Tool for Spastic reflexes [ Time Frame: Change from Baseline at 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety of ahSC in Chronic SCI With Rehabilitation
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injury
  • Paraplegia
  • Quadriplegia
  • Tetraplegia
Intervention  ICMJE Biological: Autologous human Schwann cells
Schwann cells harvested from the sural nerve of the participant will be autologously transplanted into the epicenter of the participant's spinal cord injury.
Study Arms  ICMJE Experimental: ahSC transplantation
Autologous human Schwann cells
Intervention: Biological: Autologous human Schwann cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2015)
10
Actual Study Completion Date  ICMJE August 12, 2019
Actual Primary Completion Date August 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02354625
Other Study ID Numbers  ICMJE 20140846
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W. Dalton Dietrich, University of Miami
Study Sponsor  ICMJE W. Dalton Dietrich
Collaborators  ICMJE The Miami Project to Cure Paralysis
Investigators  ICMJE
Principal Investigator: Allan Levi, MD, PhD University of Miami
Principal Investigator: James Guest, MD, PhD University of Miami
PRS Account University of Miami
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP