Completed Clinical Trials Concerning Stem Cell Therapy for Acute Traumatic Spinal Cord Injury

Abstract

Acute spinal cord injury (SCI) is a severe neurological condition limited in treatment options with high morbidity and mortality. This review analyzes the advent of stem cell therapy in the treatment of acute SCI, with a focus on the safety and efficacy of the treatment. Ten clinical trials involving 155 patients were included in this review, encompassing the usage of a multitude of stem cell subtypes with varying doses and a wide range of treatment timelines. Of the 155 patients across the included clinical trials, 70 (45%) of the patients exhibited an improvement of one or more American Spinal Injury Association impairment scale grade (AIS) and no patients exhibiting worsening of grades. Adverse events (AEs) documented in the trials were mild and unrelated to treatments, and two of the ten trials reporting occurrences of serious adverse events (SAEs) that were possibly related to the stem cell intervention. Improvement in sensory, motor, and neurological function were prevalent across the studies, with certain studies highlighting improvements in patient quality of life (QOL). Although the study’s results were promising, significant conclusions are unable to be made due to the nature of the limitations in many of the studies. Limitations included small sample sizes; non-randomized, non-controlled studies; high heterogeneity within the trials; lack of randomization; limited standardization within the trials; and incomplete reporting on both safety and efficacy outcomes in certain cases. Future research and development in the field should focus on large-scale, multicenter, randomized and controlled trials with standardized protocols to ensure significant analysis of results and outcomes. Stem cell therapy in the treatment of acute SCI represents a newly forged and promising avenue in regenerative medicine that has the potential to improve an array of patient outcomes and the field of SCI treatment.