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Clinical trial of regeneration of aged vocal folds with growth factor therapy
Author(s) -
Hirano Shigeru,
Tateya Ichiro,
Kishimoto Yo,
Kanemaru Shinichi,
Ito Juichi
Publication year - 2012
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1002/lary.22393
Subject(s) - medicine , basic fibroblast growth factor , vocal folds , adverse effect , phonation , clinical trial , atrophy , audiology , tongue , surgery , larynx , growth factor , pathology , receptor
Objectives/Hypothesis: 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. Study Design: 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.