2018 Clinical and Safety Outcomes From a Phase I Study of Neural Stem Cell Transplantation for Chronic Cervical Spinal Cord Injury

INTRODUCTION: Chronic spinal cord injury (SCI) is a devasting condition leaving individuals with permanent deficits. Stem cell replacement provides therapeutic treatment potential for cell replacement, trophic support, and axon regeneration. METHODS: Three patients underwent bilateral NSI-566 implantation and were followed for up to 60 months with prospective data collection including ISNCSCI scores, functional and pain surveys, electromyography (EMG) and Brain Motor Control Assessment (BMCA). RESULTS: The procedure was well tolerated in all patients. Subject 0202 is a 23yo male with a C7 neurologic level of injury (NLI). ISNCSCI assessment showed bilateral motor improvement (C7-C8) at 36-60 months. BMCA showed novel right triceps responsiveness during elbow flexion/extension (F/E) at 42 months. EMG analysis identified new MUAPs in the right triceps at 12 months. Subject 0203 is a 56yo male with a C6 NLI. No change in ISNCSCI score was noted up to 54 months after cell grafting. BMCA recording in the left trapezius during bilateral shoulder shrug and in the left hip adductors during passive hip F/E showed new activity at 12 months. EMG recording at 12 months identified new MUAPs in the right deltoid. Subject 0206 is a 37 yo male with a C6 NLI. No changes in ISNCSCI score, BMCA, or EMG were noted up to 60 months after cell grafting. CONCLUSIONS: In three patients with ASIA-A cervical SCI, implantation of NSI-566 led to no serious adverse events. Secondary outcome analysis showed positive INSCI, EMG, and BMCA changes in two patients. This preliminary data warrants further investigation into the use of NSI-566 in cervical SCI.