Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute SCI

NCT01739023 | Completed Phase 1 DMC

• 1 other identifier: 20081061
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety of autologous human Schwann cells (ahSC) transplantation in subjects with subacute SCI. For humans with subacute 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.

Conditions

Spinal Cord Injury; Paraplegia

Keywords

paraplegia; cell therapy; Schwann cells; spinal cord injury

Outcome Measures

Primary Outcomes (3)

• International Standards of Neurological Classification for Spinal Cord Injury

  Change from Baseline at 12 months

• MRI of spinal cord

  Change from Baseline at 12 months

• Neuropathic pain

  Change from Baseline at 12 months

Secondary Outcomes (11)

• Spinal Cord Independence Measure III

  Change from Baseline at 12 months

• Functional Independence Measure

  Change from Baseline at 12 months

• Motor Evoked Potentials

  Change from Baseline at 12 months

• Somatosensory Evoked Potentials

  Change from Baseline at 12 months

• Autonomic - Head-up Tilt

  Change from Baseline at 12 months

Study Arms (1)

Autologous Human Schwann Cells

EXPERIMENTAL

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.

Autologous Human Schwann Cells

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Persons with traumatic SCI that occurred within the previous 30 days.
• \) Between the ages of 18 and 60 at last birthday.
• \) SCI at a thoracic level between T3-T11 as defined by MRI and the most caudal level of intact motor and sensory function on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
• \) Acute SCI with ISNCSCI grade A impairment at time of enrollment.

You may not qualify if:

• \) Persons with penetrating injury of the spinal cord or complete transection of the cord, including bone fragment lacerations, as identified by magnetic resonance imaging (MRI).
• \) Persons with a lesion in the conus medullaris, cauda equina, or lower extremity peripheral nerve.
• \) Persons unable to safely undergo an MRI.
• \) Persons in whom adequate MRI imaging cannot be obtained.
• \) Persons who have developed a pulmonary embolism (PE) or deep vein thrombosis (DVT).
• \) Other traumatic injuries (e.g., CHI, another level of SCI) affecting the ability to provide informed consent and participate fully in rehabilitation.
• \) Persons with self-reported persistent severe neuropathic pain, inadequately controlled by non-narcotic medication.
• \) Persons with severe persistent mechanical or thermal hypersensitivity/allodynia at the neurological level or rostral to it as documented by clinical testing.
• \) Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment.
• \) Presence of systemic disease that might interfere with subject safety, compliance, or evaluation of the condition under study.
• \) Presence of any unstable medical or psychiatric condition that could reasonably be expected to subject the participant to unwarranted risk from participation in the study or result in a significant deterioration of his/her clinical course.
• \) Body Mass Index (BMI) \> 35.
• \) History of active substance abuse.
• \) Persons who have participated in other experimental treatments within the past 90 days deemed by the PI to represent a possible confound or enrolled in any other ongoing trial.
• \) Persons with significant lower extremity injury, previous surgery, or amputation such that would preclude satisfactory sural nerve harvest.

Sponsors & Collaborators

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

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Anderson KD, Guest JD, Dietrich WD, Bartlett Bunge M, Curiel R, Dididze M, Green BA, Khan A, Pearse DD, Saraf-Lavi E, Widerstrom-Noga E, Wood P, Levi AD. Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury. J Neurotrauma. 2017 Nov 1;34(21):2950-2963. doi: 10.1089/neu.2016.4895. Epub 2017 Mar 21.

  PMID: 28225648 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

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

• Dalton Dietrich, PhD

  University of Miami

  STUDY DIRECTOR

• 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
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

US (1)