Detailed analysis of the clinical effects of cell therapy for thoracolumbar spinal cord injury: an original study

Alok Sharma,¹ Nandini Gokulchandran,¹ Hemangi Sane,² Prerna Badhe,¹ Pooja Kulkarni,² Mamta Lohia,³ Anjana Nagrajan,³ Nancy Thomas<sup>3

1</sup>Department of Medical Services and Clinical Research, ²Department of Research and Development, ³Department of Neurorehabilitation, NeuroGen Brain and Spine Institute, Surana Sethia Hospital and Research Centre, Chembur, Mumbai, India

Background: Cell therapy is amongst the most promising treatment strategies in spinal cord injury (SCI) because it focuses on repair. There are many published animal studies and a few human trials showing remarkable results with various cell types. The level of SCI determines whether paraplegia or quadriplegia is present, and greatly influences recovery. The purpose of this study was to determine the significance of the clinical effects and long-term safety of intrathecal administration of autologous bone marrow-derived mononuclear cells, along with changes in functional independence and quality of life in patients with thoracolumbar SCI.
Methods: We undertook a retrospective analysis of a clinical study in which a nonrandomized sample of 110 patients with thoracolumbar SCI underwent autologous bone marrow-derived mononuclear cell transplantation intrathecally and subsequent neurorehabilitation, with a mean follow-up of 2 years ± 1 month. Changes on any parameters were recorded at follow-up. The data were analyzed using the Wilcoxon's signed-rank test and McNemar's test. Functional Independence Measure and American Spinal Injury Association (ASIA) scores were recorded, and a detailed neurological assessment was performed.
Results: Overall improvement was seen in 91% of patients, including reduction in spasticity, partial sensory recovery, and improvement in trunk control, postural hypotension, bladder management, mobility, activities of daily living, and functional independence. A significant association of these symptomatic improvements with the cell therapy intervention was established by the statistical analysis. Some patients showed a shift on the ASIA scale and changes in electrophysiological studies or functional magnetic resonance imaging. No major side effects were noted.
Conclusion: In patients with thoracolumbar SCI, there were statistically significant beneficial effects, both symptomatic and functional, from intrathecal autologous bone marrow-derived mononuclear cell therapy and rehabilitation. This was a safe and viable therapeutic option with no long-term side effects at 2 years. This analytical study is an early documentation of cell therapy, and can be used as a guide to devise larger more refined clinical trials.

Keywords: cell therapy, spinal cord injury, autologous, bone marrow-derived mononuclear cells, intrathecal administration