title: Selective and sustained delivery of basic fibroblast growth factor (bFGF) for treatment of peripheral arterial disease: results of a phase I trial.
abstract: OBJECTIVE
  The aim of this study was to evaluate the safety of selective and sustained delivery of basic fibroblast growth factor (bFGF) using acidic gelatine hydrogel microspheres (AGHMs) for the treatment of peripheral arterial disease (PAD).
  
  
  METHODS
  We conducted a non-randomised and uncontrolled trial involving prospective observation of eight patients (eight limbs) with PAD - five limbs with arteriosclerosis obliterans and three limbs with thromboangiitis obliterans, five limbs (three arms and two legs) with critical limb ischaemia (CLI) and three limbs with intermittent claudication (IC) - who were followed up for 6 months or more. AGHM suspension containing 100 microg bFGF was infused into the artery of the affected limb. Besides evaluation of safety and changes in symptoms, resting ankle-brachial pressure index measurement and transcutaneous PO(2) (tcPO(2)), angiography were conducted at baseline and then at various time points. Skin perfusion pressure as an index of CLI and claudication distance as an index of IC were also used to assess clinical improvement and limb perfusion.
  
  
  RESULTS
  No serious adverse events were observed. All cases showed improvement in symptoms, although this was temporary in some patients.
  
  
  CONCLUSIONS
  Selective delivery of bFGF using AGHMs was suggested to be safe and well-tolerated in patients with PAD.
authors.affiliation: Division of Vascular Surgery, Department of Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Hashimoto
authors.forename: H
authors.initials: H
authors.lastname: Koyama
authors.forename: T
authors.initials: T
authors.lastname: Miyata
authors.forename: A
authors.initials: A
authors.lastname: Hosaka
authors.forename: Y
authors.initials: Y
authors.lastname: Tabata
authors.forename: T
authors.initials: T
authors.lastname: Takato
authors.forename: H
authors.initials: H
authors.lastname: Nagawa