The Safety of ahSC in Chronic SCI With Rehabilitation

NCT02354625 | Completed Phase 1 DMC

• 1 other identifier: 20140846
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Paraplegia; Quadriplegia; Tetraplegia

Keywords

Schwann cells

Outcome Measures

Primary Outcomes (6)

• International Standards of Neurological Classification of Spinal Cord Injury

  Change from Baseline at 6 months

• Magnetic Resonance Imaging of spinal cord

  Change from Baseline at 6 months

• Neuropathic Pain Symptoms Inventory

  Change from Baseline at 6 months

• ISCI Basic Pain dataset version2

  Change from Baseline at 6 months

• Pain Diagram

  Change from Baseline at 6 months

• Quantitative Sensory Testing

  Change from Baseline at 6 months

Secondary Outcomes (22)

• Spinal Cord Independence Measure III

  Change from Baseline at 6 months

• SCI-Functional Index Computer Adaptive Testing

  Change from Baseline at 6 months

• 10-Meter Walk Test

  Change from Baseline at 6 months

• 2-Minute Walk Test

  Change from Baseline at 6 months

• Timed Up and Go

  Change from Baseline at 6 months

Study Arms (1)

ahSC transplantation

EXPERIMENTAL

Autologous human Schwann cells

Biological: Autologous human Schwann cells

Interventions

Autologous human Schwann cells BIOLOGICAL

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

ahSC transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• W. Dalton Dietrich: lead
• The Miami Project to Cure Paralysis: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Maher JL, Anderson KD, Gant KL, Cowan RE. Development and deployment of an at-home strength and conditioning program to support a phase I trial in persons with chronic spinal cord injury. Spinal Cord. 2021 Jan;59(1):44-54. doi: 10.1038/s41393-020-0486-7. Epub 2020 Jun 3.

  PMID: 32493977 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allan Levi, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• James Guest, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurosurgery

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: January 1, 2015
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (1)