Regeneration of aged vocal fold: First human case treated with fibroblast growth factor

Abstract

Background/Objectives: Aged vocal folds are characterized by atrophy of the mucosa, which caused dysphonia and is difficult to treat. We have revealed a therapeutic potential of basic fibroblast growth factor (bFGF) for tissue regeneration of the aged vocal fold. We report here the first human case that has been treated with bFGF.Study Design: Institutional review boardapproved clinical human trial.Methods: A 63-year-old male with atrophied vocal folds was treated by local injection of 10 lg of bFGF into the left vocal fold under topical anesthesia. The effects of the injection were examined after 1 to 3 months by videostroboscopy, acoustic, and aerodynamic measurements.Results: The atrophy of the vocal fold was improved at 1 week after the injection, and glottic gap disappeared. Aerodynamic and acoustic parameters also showed remarkable improvement. These positive effects were maintained up to 3 months.Conclusions: The first case with aged vocal folds treated with bFGF administration was presented. The results are encouraging, suggesting therapeutic effects of bFGF for atrophied vocal folds in human.

Retracted Publications in the Drug Literature

“…Most of the retracted articles were clinical trials (81 articles [79%]) . The remainder consisted of reviews (12 [12%]), retrospective studies (5 [5%]), and case reports (4 [4%]) . The retracted publications covered a wide range of disease states.…”

“…The remainder consisted of reviews (12 [12%]), [93][94][95][96][97][98][99][100][101][102][103][104] retrospective studies (5 [5%]), [105][106][107][108][109] and case reports (4 [4%]). [110][111][112][113] The retracted publications covered a wide range of disease states. When categorized into drug classes, 30 articles (29)% were indicated for anesthesia, analgesia, and antiinflammatory activity, and 13 (13%) were on cardiovascular agents.…”

Posterior glottic gap and age as factors predicting voice outcome of injection laryngoplasty in patients with unilateral vocal fold paralysis

“…3,15 Volume augmentation by injection is limited to the membranous portion of the vocal fold, and the inability of injection laryngoplasty to completely medialise the affected arytenoid has been recognised since the early writings of Rubin in the 1960s. However, 15 patients (25.5 per cent) required some form of additional treatment due to insufficient voice improvement.…”

Tissue engineering-based therapeutic strategies for vocal fold repair and regeneration

“…In 2009, Hirano and colleagues conducted the very first human trial on a 63-year-old male, who was treated with basic fibroblast growth factor (bFGF) for vocal fold scar and showed improvements in clinical features only after 1 week of injection. [47–49] Another strong antifibrotic potency hepatocyte growth factor (HGF) has also demonstrated significant improvements in mucosal wave amplitude, glottal incompetence and phase asymmetry via injecting HGF-containing hydrogels to scarred vocal fold tissues in in vivo canine animal models. [50–52] Although these grow factor treatments showed superior improvements compared to saline controls, complete restoration of vibratory properties and anatomical microstructures has not yet been achieved, in addition to the issue regarding safety concern of potential tumorigenicity.…”