Efficacy and outcome of bone marrow derived stem cells transplanted via intramedullary route in acute complete spinal cord injury - A randomized placebo controlled trial.

Due to lack of well-designed trials, there is no good evidence on the efficacy of stem cells in spinal cord injury. We aim to study the efficacy and outcome of bone marrow derived stem cells (BMSCs) in acute complete spinal cord injury (SCI). In this prospective study over a 3-year period, 27 patients with acute, complete SCI were randomized to receive BMSCs or placebo (intramedullary route) intraoperatively. Institutional ethics approval was taken and informed consent was taken from all patients. Functional outcome was assessed using ASIA scale, SCIM score and SSEP responses preoperatively, three and six months after surgery. Thirteen patients were available for final analysis of which six were in the stem cell group and seven received placebo. 6 patients had improvement by at least one grade in ASIA score in the stem cell group as compared to only one patient in the placebo group. However, no functional motor improvement in any of the patients. ASIA sensory score improved from a preoperative mean of 124 to 224 at 6 months compared to the static mean of 115 in the control group. Absent SSEP waveform converted to abnormal waveform at 6 months in 3 patients in the stem cell group and one patient in the control group. There was no significant difference in the SCIM scores between the groups at last follow-up. All patients in the stem cell group reported improved bladder sensation, decreased spasticity and improved posture control as compared to nine in the placebo group. BMSCs through intramedullary route are a potential therapy for acute complete SCI and more research is required in this area.