Autologous bone marrow cell transplantation in acute spinal cord injury—an Indian pilot study

Abstract

Study design: Phase-I/II, prospective, randomized, single-blind, controlled pilot study. Primary Objective: To determine the safety and feasibility of autologous bone marrow transplantation in patients with acute spinal cord injury (SCI) via two routes of transplantation as compared with controls. Setting: Indian Spinal Injuries Center, New Delhi. Methods: Twenty-one subjects with acute, American Spinal Injury Association Impairment Scale (AIS) A (complete), traumatic SCI with neurological level T1-T12, were recruited and randomized into three groups of seven subjects each. Two groups underwent cell transplantation through the intrathecal or intralesional route, whereas the third served as control. Participants were assessed at baseline and followed up at 6 months and 12-months post enrollment. Safety and tolerability were evaluated by monitoring for any adverse events. Efficacy was assessed through neurological, functional and psychological evaluation, as well as through electrophysiological studies and urodynamics. Results: Surgery was tolerated well by all participants. There were no significant adverse events attributable to the procedure. There was no significant improvement in the neurological, electrophysiological or urodynamic efficacy variables. A statistically significant improvement in functional scores as evaluated by the Spinal Cord Independence Measure and International Spinal Cord Injury Scale was observed in all groups. Conclusions: The procedure is safe and feasible in AIS A participants with thoracic-level injuries at 12-months follow-up. No efficacy could be demonstrated that could be attributed to the procedure.

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

“…A number of clinical studies concerning cell therapies with a positive outcome have led to the suggestion that combination cell therapies and/or certain transplantation approaches with rehabilitation can be more effective 107 , 123 , 128 – 130 , 136 , 138 – …”

Report: Stem cell applications in neurological practice, an expert group consensus appraisal

“…Supported by a vast preclinical evidence, cell-based approaches involving transplantation of neural and nonneural tissue elements have been applied in human SCI. [ 31 ] The majority of reports however comprise of patient testimonials or isolated case studies. A plethora of patient testimonials and case studies has reported the clinical safety and efficacy of cell transplantation after SCI.…”

Recent advances in managing a spinal cord injury secondary to trauma

“…A phase I/II RCT (N = 21) of ASIA grade A patients administered autologous BMCs intraparenchymally or intrathecally was published in 2015. No serious adverse events were reported 90 . A similar recent study in children with chronic SCI also showed no significant adverse events 91 .…”