Multicenter Trial of autologous nasal mucosal epithelial cell sheets for chronic middle ear inflammatory disease (middle ear cholesteatoma) - JMID01-01

Yamamoto Kazuhisa0 sites12 target enrollmentNovember 22, 2021

Overview

No summary available.

Registry

who.int

Start Date

November 22, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Yamamoto Kazuhisa

•1\) Patients diagnosed with pars flaccida and pars tensa cholesteatoma and classified as Stage II or Stage III AO (adhesive otitis) according to the staging of middle ear cholesteatoma (2015\).
•2\) Patients undergoing tympanoplasty with mastoidectomy. Patients who have undergone canal wall down without reconstruction, or mastoid obliteration are excluded.
•3\) Patients aged \>\=18 and \<75 at the time of consent acquisition.
•4\) Patients who have received sufficient explanation in participating in this study, and then, with sufficient understanding, have received written consent from the patient's own free will.
•5\) Outpatients who can attend the clinic according to the study schedule.

•1\) Congenital cholesteatoma; secondary cholesteatoma; Combination of pars flaccida and pars tensa cholesteatoma; unclassifiable type cholesteatoma.
•2\) Patients with a preoperative air density area in the mastoid cavity \=\>50 mm^2 in the temporal bone CT horizontal section.
•3\) Patients with obvious scarring of the nasal mucosa at the site making harvesting impossible.
•4\) Patients with contraindications to antibacterial agents or anesthetics used in this study.
•5\) Patients with hypersensitivity to penicillin, kanamycin, streptomycin, or amphotericin B antibiotics. Patients with a history of hypersensitivity to penicillin or aminoglycoside antibiotics.
•6\) Patients with a history of hypersensitivity to animals (bovine, mouse or pig).
•7\) Patients with less than 5 years history of malignancy or suspected of having malignancy.
•8\) Diabetic patients with poor glycemic control.
•9\) Patients in whom complications, etc. were observed in the transplanted ear of the investigational product or the entire body, and the investigator or subinvestigator judged it difficult to evaluate.
•10\) Pregnant women, breastfeeding women or patients who may be pregnant or patients who wish to become pregnant during the study period.