title: Controlled-release basic fibroblast growth factor for peripheral artery disease: comparison with autologous bone marrow-derived stem cell transfer.
abstract: OBJECTIVE
  We examined the safety and efficacy of controlled-release basic fibroblast growth factor (b-FGF) for peripheral artery disease (PAD), compared with autologous bone marrow mononuclear cell implantation (BMCI).
  
  
  BACKGROUND
  We recently developed a b-FGF-incorporated biodegradable hydrogel that enables slow-releasing drug delivery system.
  
  
  METHODS
  PAD patients were divided into a b-FGF group (n=10) and BMCI group (n=15). Injection of gelatin hydrogel containing 600 μg b-FGF or BMCI (0.4-5.1×10(10) cell) was performed. Visual analog pain scale (VAS), (99m)technetium-tetrofosmin (Tc-TF) scintigraphy, transcutaneous oxygen tension (TcPO(2)), and ankle-brachial index (ABI) were evaluated before and 4 weeks after each treatment, and 2-year prognosis was determined.
  
  
  RESULTS
  VAS (b-FGF 67±15 to 4±5, p<0.01, BMCI 67±42 to 5±9 mm, p<0.01) and TcPO(2) (b-FGF 16±14 to 47±17, p<0.01, BMCI 13±13 to 37±21 mmHg, p<0.01) were significantly improved in both groups. Tc-TF and ABI were not changed. Prognosis was similar between the groups (b-FGF 91%, BMCI 80%, NS).
  
  
  CONCLUSIONS
  Controlled-release b-FGF is as safe as BMCI, and its efficacy appears to be comparable. Thus, this therapy may be an alternative to BMCI.
authors.affiliation: Division of Regenerative Medicine and Cardiology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan. gen52@nms.ac.jp
authors.forename: Gen
authors.initials: G
authors.lastname: Takagi
authors.forename: Masaaki
authors.initials: M
authors.lastname: Miyamoto
authors.forename: Shuhei
authors.initials: S
authors.lastname: Tara
authors.forename: Ikuyo
authors.initials: I
authors.lastname: Takagi
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Takano
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yasutake
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Tabata
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Mizuno
mesh_terms: D000328:Adult; D000368:Aged; D001854:Bone Marrow Cells / Q000166:cytology*; D016222:Fibroblast Growth Factor 2 / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000188:drug therapy* / Q000628:therapy*; D033581:Stem Cell Transplantation / Q000379:methods*; D013234:Stem Cells / Q000166:cytology*
chemical_list: D016222:Fibroblast Growth Factor 2