title: Stem-cell therapy for peripheral arterial occlusive disease.
abstract: OBJECTIVE
  The aims of our study were to confirm the effectiveness via animal study and safety through clinical trials of using human cord blood-mononuclear cells (HCB-MNCs).
  
  
  METHODS
  We performed a dose-response animal study (HCB-MNCs: 4 × 10⁶, 4 × 10⁷ and 4 × 10⁸) using a limb ischaemia model in dogs to assess angiogenic responses. Safety assessment in humans in terms of graft-versus-host-disease was also done by observing an uncontrolled case series.
  
  
  METHODS
  Twelve animal ischaemic limbs and seven patients with thromboangiitis obliterans were treated with HCB-MNCs. These cells (4 × 10⁸) were injected into the ischaemic limb muscle of patients. The results were analysed at 8 weeks for the animal study and at 6 months for patients.
  
  
  RESULTS
  In the animal ischaemic models, the number of capillaries, angiogenic gene expression and the angiogenic factors were increased after HCB-MNC injection. In the clinical study, the seven patients experienced no graft-versus-host-disease or cardiac/cerebral complications during the follow-up period.
  
  
  CONCLUSIONS
  This preliminary study suggests that HCB-MNC might be a safe source of stem cells for treating ischaemic limbs. However, further clinical studies are needed to establish the long-term safety and the clinical efficacy of HCB-MNC transplantation in patients with ischaemic limbs.
authors.affiliation: Division of Vascular Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Kangnam-gu, Seoul 135-710, Republic of Korea.
authors.forename: A-K
authors.initials: AK
authors.lastname: Kim
authors.forename: M-H
authors.initials: MH
authors.lastname: Kim
authors.forename: S
authors.initials: S
authors.lastname: Kim
authors.forename: W
authors.initials: W
authors.lastname: Oh
authors.forename: H-K
authors.initials: HK
authors.lastname: Hong
authors.forename: K-S
authors.initials: KS
authors.lastname: Kang
authors.forename: B-S
authors.initials: BS
authors.lastname: Kim
authors.forename: D-I
authors.initials: DI
authors.lastname: Kim
mesh_terms: D000328:Adult; D000818:Animals; D036101:Cord Blood Stem Cell Transplantation / Q000009:adverse effects; D004195:Disease Models, Animal; D004285:Dogs; D005121:Extremities / Q000098:blood supply; D006086:Graft vs Host Disease / Q000209:etiology; D006801:Humans; D007511:Ischemia / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000628:therapy*; D013919:Thromboangiitis Obliterans / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult