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The Safety of ahSC in Chronic SCI With Rehabilitation

Primary Purpose

Spinal Cord Injury, Paraplegia, Quadriplegia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Autologous human Schwann cells

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Schwann cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Persons with traumatic SCI that occurred a minimum of 12 months prior to enrollment;
Between the ages of 18 and 65 at last birthday;
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);
ASIA Impairment Scale (AIS) grade A, B, or C at time of enrollment;
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:

Persons unable to safely undergo an MRI;
Persons with penetrating injury of the spinal cord or complete transection of the cord, as identified by MRI;
Persons with severe, uncorrected post-injury spinal deformity and/or spinal cord inadequately decompressed;
Persons with a cavity structure that would preclude successful transplantation, as identified by MRI;
Persons with syringomyelia - defined as patients with progressively enlarging cysts on T2 weighted images with associated neurological decline;
Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
Intolerance to functional electrical stimulation of muscles;
Exercise induced abnormalities;
Range of motion of the upper or lower extremities outside functional limits for targeted fitness and rehabilitation activities;
Evidence of bone or joint pathology that adversely influences participation in the fitness and rehabilitation activities;
Fracture, dislocation, or extremity instruments (implanted or external) that adversely influences participation in the fitness and rehabilitation activities;
Unhealed pressure ulcer;
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;
Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
Body Mass Index (BMI) ≥ 35;
History of active substance abuse;
Persons who are current participants in any interventional trial;
Persons with a history of prior intrathecal or intraspinal cell therapy for SCI;
Persons allergic to gentamicin;
Persons who test positive for HIV or Hepatitis B or C virus;
Persons with lab values significantly outside of the upper and lower limits;
Persons who can independently ambulate.

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ahSC transplantation

Arm Description

Autologous human Schwann cells

Outcomes

Primary Outcome Measures

International Standards of Neurological Classification of Spinal Cord Injury

Magnetic Resonance Imaging of spinal cord

Neuropathic Pain Symptoms Inventory

ISCI Basic Pain dataset version2

Pain Diagram

Quantitative Sensory Testing

Secondary Outcome Measures

Spinal Cord Independence Measure III

SCI-Functional Index Computer Adaptive Testing

10-Meter Walk Test

2-Minute Walk Test

Timed Up and Go

Timed Stair Climb

Capabilities of Upper Extremity Questionnaire

ISCI Upper Extremity Basic dataset

ISCI Basic Bowel dataset

ISCI Basic Lower Urinary Tract dataset

ISCI Basic Male and Female Sexual Function datasets

ISCI Quality of Life dataset

Motor Evoked Potentials

Somatosensory Evoked Potentials

Sympathetic Skin Response

Graded Strength Test

1-Repetition Maximum

Head-up Tilt

Guy Farrar Subject Global Impression of Change

Modified Ashworth Scale

Pendulum Test

Spinal Cord Assessment Tool for Spastic reflexes

Full Information

NCT ID

NCT02354625

First Posted

January 29, 2015

Last Updated

August 13, 2019

Sponsor

W. Dalton Dietrich

Collaborators

The Miami Project to Cure Paralysis

1. Study Identification

Unique Protocol Identification Number

NCT02354625

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

August 12, 2019 (Actual)

Study Completion Date

August 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

W. Dalton Dietrich

Collaborators

The Miami Project to Cure Paralysis

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury, Paraplegia, Quadriplegia, Tetraplegia

Keywords

Schwann cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ahSC transplantation

Arm Type

Experimental

Arm Description

Autologous human Schwann cells

Intervention Type

Biological

Intervention Name(s)

Autologous human Schwann cells

Intervention Description

Schwann cells harvested from the sural nerve of the participant will be autologously transplanted into the epicenter of the participant's spinal cord injury.

Primary Outcome Measure Information:

Title

International Standards of Neurological Classification of Spinal Cord Injury

Time Frame