Phase 1 Safety Trial of Autologous Human Schwann Cell Transplantation in Chronic Spinal Cord Injury

Katie L. Gant, James D. Guest, Anne E. Palermo, Aditya Vedantam, George Jimsheleishvili, Mary Bartlett Bunge, Adriana E. Brooks, Kim D. Anderson, Christine K Thomas, Andrea J. Santamaria, Monica A. Perez, Rosie Curiel, Mark S. Nash, Efrat Saraf-Lavi, Damien D. Pearse, Eva Widerström-Noga, Aisha Khan, W. Dalton Dietrich, Allan D. Levi

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

A phase 1 open-label, non-randomized clinical trial was conducted to determine feasibility and safety of autologous human Schwann cell (ahSC) transplantation accompanied by rehabilitation in participants with chronic spinal cord injury (SCI). Magnetic resonance imaging (MRI) was used to screen eligible participants to estimate an individualized volume of cell suspension to be implanted. The trial incorporated standardized multi-modal rehabilitation before and after cell delivery. Participants underwent sural nerve harvest, and ahSCs were isolated and propagated in culture. The dose of culture-expanded ahSCs injected into the chronic spinal cord lesion of each individual followed a cavity-filling volume approach. Primary outcome measures for safety and trend-toward efficacy were assessed. Two participants with American Spinal Injury Association Impairment Scale (AIS) A and two participants with incomplete chronic SCI (AIS B, C) were each enrolled in cervical and thoracic SCI cohorts (n = 8 total). All participants completed the study per protocol, and no serious adverse events related to sural nerve harvest or ahSC transplantation were reported. Urinary tract infections and skin abrasions were the most common adverse events reported. One participant experienced a 4-point improvement in motor function, a 6-point improvement in sensory function, and a 1-level improvement in neurological level of injury. Follow-up MRI in the cervical (6 months) and thoracic (24 months) cohorts revealed a reduction in cyst volume after transplantation with reduced effect over time. This phase 1 trial demonstrated the feasibility and safety of ahSC transplantation combined with a multi-modal rehabilitation protocol for participants with chronic SCI.

Original languageEnglish (US)
Pages (from-to)285-299
Number of pages15
JournalJournal of neurotrauma
Volume39
Issue number3-4
DOIs
StatePublished - Feb 2022
Externally publishedYes

Keywords

  • Schwann cells
  • autologous transplantation
  • chronic
  • human
  • paraplegia
  • spinal cord injury

ASJC Scopus subject areas

  • Clinical Neurology

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