Safety Profile, Feasibility and Early Clinical Outcome of Cotransplantation of Olfactory Mucosa and Bone Marrow Stem Cells in Chronic Spinal Cord Injury Patients

ABSTRACT

STUDY DESIGN: Prospective case series. PURPOSE: To study the safety and feasibility of cotransplantation of bone marrow stem cells and autologous olfactory mucosa in chronic spinal cord injury. OVERVIEW OF LITERATURE: Stem cell therapies are a novel method in the attempt to restitute heavily damaged tissues. We discuss our experience with this modality in postspinal cord injury paraplegics. METHODS: The study includes 9 dorsal spine injury patients with American Spinal Injury Association (ASIA) Impairment Scale (AIS) A neurological impairment who underwent de-tethering of the spinal cord followed by cotransplantation with bone marrow stem cells and an olfactory mucosal graft. Participants were evaluated at the baseline and at 6 monthly intervals. Safety and tolerability were evaluated through the monitoring for adverse events and magnetic resonance imaging evaluation. Efficacy assessment was done through neurological and functional outcome measures. RESULTS: Surgery was tolerated well by all participants. No significant difference in the ASIA score was observed, although differences in the Functional Independence Measure and Modified Ashworth Scale were statistically significant. No significant complication was observed in any of our patients, except for neurogenic pain in one participant. The follow-up magnetic resonance imaging evaluation revealed an increase in the length of myelomalacia in seven participants. CONCLUSIONS: The cotransplantation of bone marrow stem cells and olfactory mucosa is a safe, feasible and viable procedure in AIS A participants with thoracic level injuries, as assessed at the 24-month follow-up. No efficacy could be demonstrated. For application, further large-scale multicenter studies are needed.