title: A Phase III Clinical Trial Showing Limited Efficacy of Autologous Mesenchymal Stem Cell Therapy for Spinal Cord Injury.
abstract: BACKGROUND
  In our previous report, 3 of 10 patients with spinal cord injury who were injected with autologous mesenchymal stem cells (MSCs) showed motor improvement in the upper extremities and in activities of daily living.
  
  
  OBJECTIVE
  To report on the results of a phase III clinical trial of autologous MSCs therapy.
  
  
  METHODS
  Patients were selected based on the following criteria: chronic American Spinal Injury Association B status patients who had more than 12 months of cervical injury, and no neurological changes during the recent 3 months of vigorous rehabilitation. We injected 1.6 × 10 autologous MSCs into the intramedullary area at the injured level and 3.2 × 10 autologous MSCs into the subdural space. Outcome data were collected over 6 months regarding neurological examination, magnetic resonance imaging with diffusion tensor imaging, and electrophysiological analyses.
  
  
  RESULTS
  Among the 16 patients, only 2 showed improvement in neurological status (unilateral right C8 segment from grade 1 to grade 3 in 1 patient and bilateral C6 from grade 3 to grade 4 and unilateral right C8 from grade 0 to grade 1 in 1 patient). Both patients with neurological improvement showed the appearance of continuity in the spinal cord tract by diffusion tensor imaging. There were no adverse effects associated with MSCs injection.
  
  
  CONCLUSIONS
  Single MSCs application to intramedullary and intradural space is safe, but has a very weak therapeutic effect compared with multiple MSCs injection. Further clinical trials to enhance the effect of MSCs injection are necessary.
authors.affiliation: Departments of *Neurological Surgery,‡Rehabilitation Medicine, and§Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Sun Kyu
authors.initials: SK
authors.lastname: Oh
authors.forename: Kyoung Hyo
authors.initials: KH
authors.lastname: Choi
authors.forename: Jong Yoon
authors.initials: JY
authors.lastname: Yoo
authors.forename: Dae Yul
authors.initials: DY
authors.lastname: Kim
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Kim
authors.forename: Sang Ryong
authors.initials: SR
authors.lastname: Jeon
mesh_terms: D000328:Adult; D056324:Diffusion Tensor Imaging; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D059630:Mesenchymal Stem Cells / Q000166:cytology; D008875:Middle Aged; D020127:Recovery of Function; D013119:Spinal Cord Injuries / Q000628:therapy*; D014182:Transplantation, Autologous