A long-term clinical study transitioning from multicenter trial of autologous nasal mucosal epithelial cell sheets for chronic middle ear inflammatory disease (middle ear cholesteatoma)

JRCT ID: jRCT2033220518

Registered date:19/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic middle ear inflammatory disease (middle ear cholesteatoma)
• Date of first enrollment: 23/01/2023
• Target sample size: 12
• Study type: Observational

Outcome(s)

Primary Outcome

Endpoints
Efficacy endpoints
1) Evaluation of the presence of aeration in the mastoid cavity at week 96 after transplant of investigational product.
2) Evaluation based on postoperative results using the Japan Otological Society criteria (postoperative air-bone gap, hearing improvement, and postoperative hearing level).
3) Presence or absence of tympanic membrane adhesions
4) Presence or absence of a recurrent cholesteatoma
5) Evaluation of the presence of aeration in the mastoid cavity over time
6) Evaluation of the presence of aeration in the tympanic cavity over time

Safety endpoints
1) Important safety endpoints
Number of subjects with exacerbation of inflammation in the middle ear cavity for which a causal relationship to the investigational product transplantation could not be ruled out and the incidence (%)
2) Number and incidence of adverse events and defective products(%).
3) Number and incidence of significantly defective products(%).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Patients who were enrolled in JMID01-01 study and received transplant of investigational product.
2) 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.
3) Outpatients who can attend the hospital according to the study schedule.

Exclude criteria

1) Patients who are participating in other clinical trials.
2) Patients who wish to become pregnant during the study period.
3) Patients judged inappropriate for the study by the investigator or sub-investigator.

Related Information

• Primary Sponsor: Kazuhisa Yamamoto
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development