title: Autologous mesenchymal stromal cell transplantation for spinal cord injury: A Phase I pilot study.
abstract: OBJECTIVE
  Mesenchymal stromal cell (MSC) transplantation has immerged as promising therapeutic approach to treat spinal cord injury (SCI). In this pilot study, we investigated the safety of intrathecal injection of autologous bone marrow-derived MSCs in nine patients with SCI.
  
  
  METHODS
  Patients with complete SCI at the thoracic level were divided into two groups: chronic (>6 months, group 1) and sub-acute SCI (<6 months, group 2), according to time elapsed since injury. MSCs were isolated by density gradient separation of autologous bone marrow harvested from the iliac crest. Cells were cultured in a Good Manufacturing Practice-compliant facility to produce clinical scale dose. After quality control testing, MSCs were injected back to patients by intrathecal injection. Safety was defined as absence of adverse event and side effects after 1 month after receiving the injection.
  
  
  RESULTS
  Six patients had chronic SCI with a median duration of 33 months since date of injury (range: 10-55 months), and three patients were in sub-acute phase of disease. Each patient received two or three injections with a median of 1.2 × 10(6) MSCs/kg body weight. No treatment-related adverse event was observed during median follow-up of 720 days (range: 630-826 days) in group 1 and 366 days (range: 269-367 days) in group 2, respectively.
  
  
  CONCLUSIONS
  This pilot study demonstrated that autologous MSCs can be safely administered through intrathecal injection in spinal cord injury patients. Further investigation through randomized, placebo-controlled trials is needed.
authors.affiliation: Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan; Quaid-i-Azam University, Islamabad, Pakistan. Electronic address: humayun225@gmail.com.
authors.forename: Humayoon Shafique
authors.initials: HS
authors.lastname: Satti
authors.affiliation: Armed Forces Institute of Rehabilitation Medicine, Rawalpindi, Pakistan.
authors.forename: Akhtar
authors.initials: A
authors.lastname: Waheed
authors.affiliation: Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan.
authors.forename: Parvez
authors.initials: P
authors.lastname: Ahmed
authors.affiliation: Armed Forces Institute of Rehabilitation Medicine, Rawalpindi, Pakistan.
authors.forename: Khalil
authors.initials: K
authors.lastname: Ahmed
authors.affiliation: Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan; Quaid-i-Azam University, Islamabad, Pakistan.
authors.forename: Zaineb
authors.initials: Z
authors.lastname: Akram
authors.affiliation: Armed Forces Institute of Rehabilitation Medicine, Rawalpindi, Pakistan.
authors.forename: Tariq
authors.initials: T
authors.lastname: Aziz
authors.affiliation: Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan.
authors.forename: Tariq Mehmood
authors.initials: TM
authors.lastname: Satti
authors.affiliation: Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan.
authors.forename: Nighat
authors.initials: N
authors.lastname: Shahbaz
authors.affiliation: Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan.
authors.forename: Mehreen Ali
authors.initials: MA
authors.lastname: Khan
authors.affiliation: Armed Forces Institute of Rehabilitation Medicine, Rawalpindi, Pakistan.
authors.forename: Salman Akbar
authors.initials: SA
authors.lastname: Malik
mesh_terms: D000328:Adult; D005240:Feasibility Studies; D006801:Humans; D007278:Injections, Spinal; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D010865:Pilot Projects; D013119:Spinal Cord Injuries / Q000628:therapy*; D014182:Transplantation, Autologous; D055815:Young Adult
keywords: clinical trial; mesenchymal stromal cells; spinal cord injury; transplantation