Faculty Collaboration Database

Phase 1 Safety Trial of Autologous Human Schwann Cell Transplantation in Chronic Spinal Cord Injury. J Neurotrauma 2022 Feb;39(3-4):285-299

Date

03/25/2021

Pubmed ID

33757304

Pubmed Central ID

PMC9360180

DOI

10.1089/neu.2020.7590

Scopus ID

2-s2.0-85123877486 (requires institutional sign-in at Scopus site)   38 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.

Author List

Gant KL, Guest JD, Palermo AE, Vedantam A, Jimsheleishvili G, Bunge MB, Brooks AE, Anderson KD, Thomas CK, Santamaria AJ, Perez MA, Curiel R, Nash MS, Saraf-Lavi E, Pearse DD, Widerström-Noga E, Khan A, Dietrich WD, Levi AD

Author

Aditya Vedantam MD Assistant Professor in the Neurosurgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Cell Transplantation
Female
Humans
Lumbar Vertebrae
Magnetic Resonance Imaging
Male
Middle Aged
Schwann Cells
Spinal Cord Injuries
Sural Nerve
Thoracic Vertebrae
Transplantation, Autologous
Treatment Outcome