title: Safety and efficacy of granulocyte-colony-stimulating factor administration following autologous intramuscular implantation of bone marrow mononuclear cells: a randomized controlled trial in patients with advanced lower limb ischemia.
abstract: OBJECTIVE
  The aim was to investigate the therapeutic effect of granulocyte-colony-stimulating factor (G-CSF) administration following implantation of autologous bone marrow mononuclear cells (BM MNC) for patients with lower limb ischemia.
  
  
  METHODS
  The design was a randomized controlled trial. Fifteen patients with severe chronic limb ischemia were treated with autologous BM MNC [without G-CSF (MNC-G-CSF) or combined with G-CSF administration for 5 days following transplantation (MNC+G-CSF)].
  
  
  RESULTS
  All clinical parameters, including ankle brachial index, visual analog scale and pain-free walking distance, showed a mean improvement from baseline, which was measured at 4 and 24 weeks after transplantation in both groups. However, in three (20%) patients, the clinical course did not improve and limb salvage was not achieved. No significant difference was observed among the patients treated in the MNC-G-CSF and MNC+G-CSF groups. No severe adverse reactions were reported during the study period. No relationship was observed between both the numbers of viable MNC or CD34+ cells and the clinical outcome.
  
  
  CONCLUSIONS
  Autologous transplantation of BM MNC into ischemic lower limbs is safe, feasible and efficient for patients with severe peripheral artery disease. However, the administration of G-CSF following cell transplantation does not improve the effect of BM MNC implantation and therefore would not have any beneficial value in clinical applications of such cases.
authors.affiliation: Department of Vascular Surgery, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mohammad Reza
authors.initials: MR
authors.lastname: Zafarghandi
authors.forename: Hassan
authors.initials: H
authors.lastname: Ravari
authors.forename: Nasser
authors.initials: N
authors.lastname: Aghdami
authors.forename: Mehrnaz
authors.initials: M
authors.lastname: Namiri
authors.forename: Kasra
authors.initials: K
authors.lastname: Moazzami
authors.forename: Ehsan
authors.initials: E
authors.lastname: Taghiabadi
authors.forename: Abdorreza
authors.initials: A
authors.lastname: Fazel
authors.forename: Behshad
authors.initials: B
authors.lastname: Pournasr
authors.forename: Ali
authors.initials: A
authors.lastname: Farrokhi
authors.forename: Ramezan Ali
authors.initials: RA
authors.lastname: Sharifian
authors.forename: Javad
authors.initials: J
authors.lastname: Salimi
authors.forename: Majid
authors.initials: M
authors.lastname: Moini
authors.forename: Hossein
authors.initials: H
authors.lastname: Baharvand
mesh_terms: D000328:Adult; D000368:Aged; D055109:Ankle Brachial Index; D016026:Bone Marrow Transplantation; D002452:Cell Count; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007273:Injections, Intramuscular; D007511:Ischemia / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D007963:Leukocytes, Mononuclear / Q000187:drug effects / Q000378:metabolism* / Q000473:pathology / Q000637:transplantation; D035002:Lower Extremity / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D020127:Recovery of Function; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor