title: Safety profile, feasibility and early clinical outcome of cotransplantation of olfactory mucosa and bone marrow stem cells in chronic spinal cord injury patients.
abstract: METHODS
  Prospective case series.
  
  
  OBJECTIVE
  To study the safety and feasibility of cotransplantation of bone marrow stem cells and autologous olfactory mucosa in chronic spinal cord injury.
  
  
  BACKGROUND
  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.
authors.affiliation: Department of Orthopaedic Surgery, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Vijay G
authors.initials: VG
authors.lastname: Goni
authors.affiliation: Department of Neurosurgery, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Chhabra
authors.affiliation: Department of Otolaryngology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Ashok
authors.initials: A
authors.lastname: Gupta
authors.affiliation: Department of Transfusion Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Neelam
authors.initials: N
authors.lastname: Marwaha
authors.affiliation: Department of Orthopaedic Surgery, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Mandeep S
authors.initials: MS
authors.lastname: Dhillon
authors.affiliation: Department of Orthopaedic Surgery, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Sudesh
authors.initials: S
authors.lastname: Pebam
authors.affiliation: Department of Orthopaedic Surgery, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Nirmal Raj
authors.initials: NR
authors.lastname: Gopinathan
authors.affiliation: SBK Spine Clinic, Bangalore, India.
authors.forename: Shashidhar
authors.initials: S
authors.lastname: Bangalore Kantharajanna
keywords: Spinal cord regeneration; Stem cells; Thorax