title: Intrathecal injection of CD133-positive enriched bone marrow progenitor cells in children with cerebral palsy: feasibility and safety.
abstract: OBJECTIVE
  Recent studies have proposed that cellular transplantation may have some regenerative and functional efficacy in the treatment of cerebral palsy (CP); however, much remains to be understood regarding its safety, feasibility and efficacy. This study was initiated to evaluate the safety of autologous bone marrow-derived CD133(+) cell intrathecal injection.
  
  
  METHODS
  Children (n = 12), aged 4 to 12 years, who were diagnosed with different types of CP underwent BM aspiration. CD133(+) cells were enriched from the BM samples and intrathecally injected. The Gross Motor Function Measure (GMFM-66), Gross Motor Function Classification System (GMFCS), UK FIM+FAM, Functional Independence Measure (FIM) and Functional Assessment Measure (FAM) were assessed at baseline and 6 months after the procedure. Patients' ability to balance was measured by the Berg Balance Scale (BBS), and severity of spasticity was evaluated by the Modified Ashworth Scale. Magnetic resonance imaging was done at baseline and 6 months after therapy. This study was registered in ClinicalTrials.gov (NCT01404663).
  
  
  RESULTS
  There were no adverse events detected by clinical and laboratory tests or imaging studies, with the exception of a seizure in 1 patient. A significant improvement was observed 6 months after cell transplantation versus baseline according to GMFM, GMFCS, FIM+FAM, Ashworth Scale, and BBS outcomes.
  
  
  CONCLUSIONS
  Subarachnoid injection of CD133-positive enriched bone marrow progenitor cells in children with CP is a safe approach. The results suggest a possible short-term improvement in neurological function.
authors.affiliation: Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Tehran, Iran.
authors.forename: Alireza
authors.initials: A
authors.lastname: Zali
authors.affiliation: Department of Regenerative Medicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, Royan Institute for Reproductive Biomedicine, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
authors.forename: Leila
authors.initials: L
authors.lastname: Arab
authors.affiliation: Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Tehran, Iran.
authors.forename: Farzad
authors.initials: F
authors.lastname: Ashrafi
authors.affiliation: Department of Regenerative Medicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, Royan Institute for Reproductive Biomedicine, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
authors.forename: Soura
authors.initials: S
authors.lastname: Mardpour
authors.affiliation: Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
authors.forename: Maryam
authors.initials: M
authors.lastname: Niknejhadi
authors.affiliation: Mahak Cancer Children's Hospital, Tehran, Iran.
authors.forename: Amir Abbas
authors.initials: AA
authors.lastname: Hedayati-Asl
authors.affiliation: Department of Pediatrics, Shohada Tajrish Hospital, Tehran, Iran.
authors.forename: Aliasghar
authors.initials: A
authors.lastname: Halimi-Asl
authors.affiliation: Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Tehran, Iran.
authors.forename: Davood
authors.initials: D
authors.lastname: Ommi
authors.affiliation: Department of Regenerative Medicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, Royan Institute for Reproductive Biomedicine, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
authors.forename: Seyyedeh-Esmat
authors.initials: SE
authors.lastname: Hosseini
authors.affiliation: Department of Regenerative Medicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, Royan Institute for Reproductive Biomedicine, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
authors.forename: Hossein
authors.initials: H
authors.lastname: Baharvand
authors.affiliation: Department of Regenerative Medicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, Royan Institute for Reproductive Biomedicine, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran. Electronic address: Nasser.Aghdami@RoyanInstitute.org.
authors.forename: Nasser
authors.initials: N
authors.lastname: Aghdami
mesh_terms: D000071916:AC133 Antigen; D015703:Antigens, CD / Q000378:metabolism*; D001854:Bone Marrow Cells; D064987:Cell- and Tissue-Based Therapy / Q000379:methods; D002547:Cerebral Palsy / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006023:Glycoproteins / Q000378:metabolism*; D006412:Hematopoietic Stem Cells; D006801:Humans; D007278:Injections, Spinal; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D059630:Mesenchymal Stem Cells / Q000166:cytology; D009048:Motor Skills / Q000502:physiology*; D009128:Muscle Spasticity / Q000628:therapy*; D010455:Peptides / Q000378:metabolism*; D012449:Safety
chemical_list: D000071916:AC133 Antigen; D015703:Antigens, CD; D006023:Glycoproteins; C000606023:PROM1 protein, human; D010455:Peptides
keywords: CD133+ cells; bone marrow; cell therapy; cerebral palsy; intrathecal injection