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)

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) - JMID01-02

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2033220518

Enrollment

Registered

2022-12-19

Start date

2023-01-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic middle ear inflammatory disease (middle ear cholesteatoma)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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(%).	—

Measure

Time frame

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(%).

—

Contacts

Public ContactTsunetaro Morino

Jikei University Hospital

JMID@jikei.ac.jp+81-3-3433-1111

Outcome results