Clinical trial of regeneration of aged vocal folds with growth factor therapy

Authors


  • Given as an oral presentation at the American Laryngological Association 132nd Annual Meeting Combined Otolaryngology Spring Meetings, Chicago, Illinois, U.S.A., April 27–28, 2011.

  • This study was supported in part by the National Institute of Biomedical Innovation. The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Abstract

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.

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