title: Clinical trial of regeneration of aged vocal folds with growth factor therapy.
abstract: OBJECTIVE
  Aged vocal folds are characterized by atrophy of the mucosa, which causes mucosal wave deficiency and glottal insufficiency. This clinical trial examined the regenerative effects and safety considerations of basic fibroblast growth factor (bFGF) on restoration of aged vocal folds.
  
  
  METHODS
  Institutional review board-approved human clinical trial.
  
  
  METHODS
  Ten patients (6 men and 4 women; mean age, 70.1 years) were recruited in the trial. Ten micrograms of bFGF was injected into each treated vocal fold. Injection was performed unilaterally or bilaterally according to each patient's need and repeated up to seven times if necessary. Patient follow-up continued for at least 6 months. The effectiveness of the treatment was assessed by stroboscopic, acoustic, and aerodynamic measurements.
  
  
  RESULTS
  All patients showed improvement of voice. Significant improvements in maximum phonation time, mean flow rate, jitter, shimmer, and noise-to-harmonic ratio lasted for at least 1 year. No allergic or long-term adverse effects were noted.
  
  
  CONCLUSIONS
  This clinical trial suggests that bFGF may be effective and safe as a regenerative agent for aged vocal folds.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan. hirano@ent.kuhp.kyoto-u.ac.jp
authors.forename: Shigeru
authors.initials: S
authors.lastname: Hirano
authors.forename: Ichiro
authors.initials: I
authors.lastname: Tateya
authors.forename: Yo
authors.initials: Y
authors.lastname: Kishimoto
authors.forename: Shin-ichi
authors.initials: S
authors.lastname: Kanemaru
authors.forename: Juichi
authors.initials: J
authors.lastname: Ito
mesh_terms: D000368:Aged; D000375:Aging; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000008:administration & dosage*; D005500:Follow-Up Studies; D048091:Guided Tissue Regeneration / Q000379:methods*; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D020127:Recovery of Function; D049489:Stroboscopy; D016896:Treatment Outcome; D014827:Vocal Cords; D014832:Voice Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D014833:Voice Quality
chemical_list: D016222:Fibroblast Growth Factor 2