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Clinical trial of regeneration of aged vocal folds with growth factor therapy.
OBJECTIVES/HYPOTHESISAged 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.
STUDY DESIGNInstitutional review board-approved human clinical trial.
METHODSTen 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.
RESULTSAll 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.
CONCLUSIONSThis clinical trial suggests that bFGF may be effective and safe as a regenerative agent for aged vocal folds.
Department of Otolaryngology-Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan. email@example.com, , ,
The Laryngoscope 122:2 2012 Feb pg 327-31
Fibroblast Growth Factor 2
Guided Tissue Regeneration
Recovery of Function
Pub Type(s)Clinical Trial
Research Support, Non-U.S. Gov't