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

• DOI: 10.1089/neu.2020.7590
• Publication Date: 2021-03-24T08:38:10Z
• Authors: Katie L. Gant; James D. Guest; Anne E. Palermo; Aditya Vedantam; George Jimsheleis...; 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
• Keywords: Sural nerve

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) used screen eligible estimate an individualized volume suspension be implanted. The incorporated standardized multi-modal before after delivery. Participants underwent sural nerve harvest, ahSCs were isolated propagated culture. dose culture-expanded injected into the lesion each individual followed a cavity-filling approach. Primary outcome measures for trend-toward efficacy assessed. Two American Spinal Injury Association Impairment Scale (AIS) two incomplete SCI (AIS B, C) enrolled cervical thoracic cohorts (n = 8 total). All completed study per protocol, no serious adverse events related harvest or ahSC reported. Urinary tract infections skin abrasions most common One participant experienced 4-point improvement motor function, 6-point sensory 1-level neurological level injury. Follow-up MRI (6 months) (24 revealed reduction cyst reduced effect over time. This demonstrated combined protocol SCI.