Combined Mesenchymal Stem Cell and Schwann Cell Therapy in Spinal Cord Injury: A 9-Year Cohort Study

Background: Spinal cord injury (SCI) could lead to significant disabilities with remarkable socioeconomic burden among patients. Currently, given the complex pathophysiology, there is no definite treatment for this condition. Based on supporting preclinical evidence, this prospective cohort study aimed to evaluate the effects of combined intrathecal administration of autologous bone marrow-derived mesenchymal stem cells (MSCs) and Schwann cells (SCs) in patients with complete spinal cord injury. Methods: This was a single-center, prospective, observational cohort study, including patients with complete traumatic SCI who underwent combined cell therapy with autologous bone marrow-derived MSCs and SCs between August 2013 and September 2022. The outcome measures of the study were safety profile as well as neurological and functional improvements assessed by the American Spinal Injury Association (ASIA), Spinal Cord Independence Measure (SCIM-III), and World Health Organization Quality of Life Brief Version (WHOQOL-BREF) at 6- and 12-month after the injection.Results: A total of 106 patients with complete SCI underwent the study intervention and were followed up in this study. No adverse event attributable to the study intervention was noted over the study period. Significant improvements in ASIA (motor, light touch, and pinprick) scores, SCIM-III total and subscale (self-care, respiration and sphincter management, and mobility) scores, and WHOQOL-BREF total and domain scores were noted after 12 months in patients. Moreover, significant improvements in all the aforementioned outcomes were found in all subgroups, including cervical, thoracolumbar, subacute, and chronic SCI. Based on multiple regression analysis, the improvements in the ASIA motor score were significantly associated with the level of injury. Similarly, improvements in SCIM-III total and mobility scores were significantly associated with the time elapsed since the injury. Conclusion: The combined cell therapy using autologous MSCs and SCs led to significant improvements in neurological and functional outcomes as well as patients’ quality of life. Future studies could evaluate the additional effects of combining this approach with other modalities or make comparisons between their efficacy.Funding: Shahid Beheshti University of Medical Sciences.Declaration of Interest: The authors report no competing interests.Ethical Approval: This investigation was a single-center, prospective, observational cohort study approved by the Ethics in Medical Research Committee of Shahid Beheshti University of Medical Sciences (IR.SBMU.REC.1401.023).Before performing any procedure, including the study intervention, cell culture, and biopsy specimen analysis, written informed consent was obtained from the participants. They were also given a thorough explanation about the study intervention, the experimental nature of the study, and potential associated adverse events (AEs). To improve the quality of data reporting, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines were followed in this study.