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

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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  • Publisher Full Text
  • Authors

    Hirano S, Tateya I, Kishimoto Y, Kanemaru S, Ito J

    Institution

    Department of Otolaryngology-Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan. hirano@ent.kuhp.kyoto-u.ac.jp

    Source

    The Laryngoscope 122:2 2012 Feb pg 327-31

    MeSH

    Aged
    Aging
    Female
    Fibroblast Growth Factor 2
    Follow-Up Studies
    Guided Tissue Regeneration
    Humans
    Injections
    Male
    Middle Aged
    Patient Satisfaction
    Recovery of Function
    Stroboscopy
    Treatment Outcome
    Vocal Cords
    Voice Disorders
    Voice Quality

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22252956