Combining Cell Therapy with Autologous Schwann Cell and Bone Marrow-derived Mesenchymal Stem Cell in Patients with Subacute Complete Spinal Cord Injury: Safety Considerations and Possible Outcomes

Background Cellular transplantations have promising effects on treating spinal cord injury (SCI) patients. Safety alongside the complementary characteristics of Mesenchymal stem cells (MSC) and Schwann cells (SC) are suggested to be the two of the best candidates in SCI treatment. In this study, we assessed the safety and efficacy of intrathecal co-transplantation of autologous bone marrow MSC and SC in the patients with subacute traumatic complete SCI.Methods Eleven patients with complete SCI (American Spinal Injury Association Impairment Scale (AIS); grade A) were enrolled in this study during the subacute period of injury. The patients received intrathecal autologous combination of MSC and SC and were followed-up for 12 months. We assessed neurological changes by American Spinal Injury Association’s (ASIA) sensory-motor scale, functional recovery by spinal cord independence measure (SCIM-III), and subjective changes along with adverse events (AE) with our checklist. Furthermore, electromyography (EMG), nerve conduction velocity (NCV), magnetic resonance imaging (MRI), and urodynamic study (UDS) were conducted for all the patients at the baseline, 6 months, and one year after the intervention.Results Light touch ASIA score alterations were approximately the same as the pinprick changes (11.6 ± 13.1 and 12 ± 13, respectively) in 50% of the cervical and 63% of the lumbar-thoracic patients and both were more than the motor score alterations (9.5 ± 3.3 in 75% of the cervical and 14% of the lumbar-thoracic patients). SCIM III total scores (21.2 ± 13.3) and all its sub-scores (“respiration and sphincter management” (15 ± 9.9), “mobility” (9.5 ± 13.3), and “self-care” (6 ± 1.4)) had significant changes after cell injection. Our findings support that the most remarkable positive, subjective improvements were in trunk movement, equilibrium in standing/sitting position, sensation of the bladder and rectal filling, and ability of voluntary voiding. Our safety evaluation revealed no systemic complications and radiological images showed no neoplastic overgrowth, syringomyelia, or pseudo-meningocele.Conclusion The present study showed that autologous SC and bone marrow-derived MSC transplantation at the subacute stage of SCI could reveal significant improvement in sensory and neurological functions among the patients. It appears that using this combination of cells is safe and effective for clinical application to the spinal cord regeneration during the subacute period.