論文

査読有り
2018年4月1日

A phase I/II exploratory clinical trial for intracordal injection of recombinant hepatocyte growth factor for vocal fold scar and sulcus

Journal of Tissue Engineering and Regenerative Medicine
  • Shigeru Hirano
  • ,
  • Atsuhiko Kawamoto
  • ,
  • Ichiro Tateya
  • ,
  • Masanobu Mizuta
  • ,
  • Yo Kishimoto
  • ,
  • Nao Hiwatashi
  • ,
  • Yoshitaka Kawai
  • ,
  • Takuya Tsuji
  • ,
  • Ryo Suzuki
  • ,
  • Mami Kaneko
  • ,
  • Yasushi Naito
  • ,
  • Tatsuo Kagimura
  • ,
  • Tatsuo Nakamura
  • ,
  • Shin-Ichi Kanemaru

12
4
開始ページ
1031
終了ページ
1038
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1002/term.2603
出版者・発行元
John Wiley and Sons Ltd

Vocal fold scar and sulcus are intractable diseases with no effective established treatments. Hepatocyte growth factor (HGF) has preclinically proven to have potent antifibrotic and regenerative effects on vocal fold scar. The current Phase I/II clinical trial aims to examine the safety and effectiveness of intracordal injection of a recombinant human HGF drug for patients with vocal fold scar or sulcus. This is an open-label, dose-escalating, first-in-human clinical trial. Eighteen patients with bilateral vocal fold scar or sulcus were enrolled and divided into three groups: Step I received 1 μg of HGF per vocal fold
Step II received 3 μg of HGF
and Step III received 10 μg of HGF. Injections were administered once weekly for 4 weeks. The protocol treatment was performed starting with Step I and escalating to Step III. Patients were followed for 6 months post-treatment. Local and systemic safety aspects were examined as primary endpoints, and therapeutic effects were assessed as secondary endpoints using voice handicap index-10
maximum phonation time
vocal fold vibratory amplitude
grade, rough, breathy, asthenic, strained scale
and jitter. The results indicated no serious drug-related adverse events in either the systemic or local examinations. In whole-subject analysis, voice handicap index-10, vocal fold vibratory amplitude, and grade, rough, breathy, asthenic, strained scale were significantly improved at 6 months, whereas maximum phonation time and jitter varied. There were no significant differences in phonatory data between the step groups. In conclusion, intracordal injection of a recombinant human HGF drug was safe, feasible, and potentially effective for human patients with vocal fold scar or sulcus.

リンク情報
DOI
https://doi.org/10.1002/term.2603
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/29084372
Scopus
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85038949622&origin=inward
Scopus Citedby
https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85038949622&origin=inward
ID情報
  • DOI : 10.1002/term.2603
  • ISSN : 1932-7005
  • ISSN : 1932-6254
  • eISSN : 1932-7005
  • PubMed ID : 29084372
  • SCOPUS ID : 85038949622

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