title: Clinical safety and primary efficacy of bone marrow mesenchymal cell transplantation in subacute spinal cord injured patients.
abstract: BACKGROUND
  In recent years, some studies were conducted to evaluate the effects of stem cells from different sources on patients with spinal cord injury (SCI). This study was carried out to evaluate the feasibility and therapeutic potential of autologous bone marrow cell (BMC) transplantation in 11 complete spinal cord injured patients at thoracic level.
  
  
  METHODS
  This nonrandomized clinical trial compared the results of autologous BMC transplantation into cerebrospinal fluid (CSF) via lumbar puncture (LP) in 11 patients having complete SCI, with 20 patients as control group who received conventional treatment without BMC transplantation. The patients underwent preoperative and follow-up neurological assessments using the American Spinal Injury Association (ASIA) impairment scale. Then, the participants were followed for 12-33 months.
  
  
  RESULTS
  Eleven patients with the mean age of 33.2±8.9 years and 20 patients with the mean age of 33.5±7.2 years were enrolled in the study and in the control group, respectively. None of the patients in the study and control group experienced any adverse reaction and complications, neither after routine treatment nor after cell transplantation. Five patients out of 11 (45.5%) in the study group and three patients in the control group (15%) showed marked recovery, but the result was statistically borderline (P=0.095).
  
  
  CONCLUSIONS
  We conclude that transplantation of autologous BMC via LP is a feasible and safe technique, but at the moment, no clear answer can be given regarding the clinical potential, despite a potential tendency to treat SCI patients, observed through statistics.
authors.affiliation: Neuroscience Research Center, Kerman University of Medical Sciences, Department of Neurosurgery, Bahonar Hospital, Kerman, Iran.
authors.forename: Saeid
authors.initials: S
authors.lastname: Karamouzian
authors.forename: Seyed Noureddin
authors.initials: SN
authors.lastname: Nematollahi-Mahani
authors.forename: Nozar
authors.initials: N
authors.lastname: Nakhaee
authors.forename: Hossein
authors.initials: H
authors.lastname: Eskandary
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D002454:Cell Differentiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007796:Laminectomy; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D018579:Patient Selection; D011239:Prednisolone / Q000627:therapeutic use; D013119:Spinal Cord Injuries / Q000145:classification / Q000628:therapy*; D017154:Stromal Cells; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D011239:Prednisolone