title: Autologous bone-marrow mononuclear cell implantation reduces long-term major amputation risk in patients with critical limb ischemia: a comparison of atherosclerotic peripheral arterial disease and Buerger disease.
abstract: BACKGROUND
  Bone-marrow mononuclear cell (BM-MNC) implantation improves ischemic symptoms in patients with critical limb ischemia (CLI). The purpose of this study was to evaluate long-term clinical outcomes after autologous BM-MNC implantation in patients with CLI.
  
  
  RESULTS
  We assessed long-term clinical outcomes after BM-MNC implantation in 51 patients with CLI, including 25 patients with peripheral arterial disease (PAD) and 26 patients with Buerger disease. Forty-six CLI patients who had no BM-MNC implantation served as control subjects. Median follow-up period was 4.8 years. The 4-year amputation-free rates after BM-MNC implantation were 48% in PAD patients and 95% in Buerger disease, and they were 0% in control PAD patients and 6% in control Buerger disease. The 4-year overall survival rates after BM-MNC implantation were 76% in PAD patients and 100% in Buerger disease, and they were 67% in control PAD patients and 100% in control Buerger disease. Multivariable Cox proportional hazards analysis revealed that BM-MNC implantation correlated with prevention of major amputation and that hemodialysis and diabetes mellitus correlated with major amputation. In Buerger disease, ankle brachial pressure index and transcutaneous oxygen pressure were significantly increased after 1 month and remained high during 3-year follow-up. However, in patients with PAD, ankle brachial pressure index and transcutaneous oxygen pressure significantly increased after 1 month and gradually decreased during 3-year follow-up and returned to baseline levels.
  
  
  CONCLUSIONS
  These findings suggest that BM-MNC implantation is safe and effective in patients with CLI, especially in patients with Buerger disease. Clinical Trial Registration- URL: http://home.hiroshima-u.ac.jp/angio/. Unique identifier: 001769.
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.
authors.forename: Naomi
authors.initials: N
authors.lastname: Idei
authors.forename: Junko
authors.initials: J
authors.lastname: Soga
authors.forename: Takaki
authors.initials: T
authors.lastname: Hata
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Fujii
authors.forename: Noritaka
authors.initials: N
authors.lastname: Fujimura
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Mikami
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Maruhashi
authors.forename: Kenji
authors.initials: K
authors.lastname: Nishioka
authors.forename: Takayuki
authors.initials: T
authors.lastname: Hidaka
authors.forename: Yasuki
authors.initials: Y
authors.lastname: Kihara
authors.forename: Moniruddin
authors.initials: M
authors.lastname: Chowdhury
authors.forename: Kensuke
authors.initials: K
authors.lastname: Noma
authors.forename: Akira
authors.initials: A
authors.lastname: Taguchi
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Chayama
authors.forename: Taijiro
authors.initials: T
authors.lastname: Sueda
authors.forename: Yukihito
authors.initials: Y
authors.lastname: Higashi
mesh_terms: D000368:Aged; D000671:Amputation, Surgical; D016026:Bone Marrow Transplantation; D017690:Cell Transplantation; D005260:Female; D006801:Humans; D007511:Ischemia; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000601:surgery*; D012307:Risk Factors; D013919:Thromboangiitis Obliterans / Q000601:surgery*; D014182:Transplantation, Autologous; D016896:Treatment Outcome