JPRN-jRCT2051230028
Recruiting
Phase 3
Regenerative Therapy for Soft Tissue Defects of the External Auditory Meatus with NPC-18
Kanemaru Shin-ichi0 sites20 target enrollmentMay 26, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Subject has soft tissue defect of external auditory meatus resulting from injury or postoperative da
- Sponsor
- Kanemaru Shin-ichi
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Subject has given written informed consent. For subject under 18 years of age, subject and their legal representatives (care givers, parents) have given written consent (or assent if under 16 years of age).
- •2\)Subject aged between 12 and 90 years of age at the time of consent.
- •3\)Subject has unilateral intractable Grade I soft tissue defect of external auditory meatus (EAM) due to trauma inflicted 3 months or more prior to study treatment initiation.
- •4\)Subject has soft tissue defect of EAM which has not tended to heal at least 3 weeks or more from screening phase (Visit S1\) to the start day of study treatment initiation (Visit T1\), if unilateral Grade I soft tissue defect of EAM due to trauma occurred less than 3 months prior to study treatment initiation.
- •5\)Subject has unilateral Grade II or III soft tissue defect of EAM due to trauma inflicted one month or more prior to study treatment initiation.
- •6\)Subject has or is expected to have unilateral soft tissue defect of EAM due to surgical treatment.
Exclusion Criteria
- •1\)Subject has soft tissue defect of EAM due to burns or radiotherapy.\*
- •2\)Subject has external auditory canal cholesteatoma extending within the mastoid cells or within the tympanic cavity.\*
- •3\)Subject has malignancy/suspected malignancy or a history of malignancy in the ear.\*
- •4\)Subject has otitis externa or active otitis media.\*
- •5\)Subject has infection or otorrhea of tympanic membrane, EAM, middle ear or tympanic cavity detected by inspection through a microscope.\*
- •6\)Subject has a history of external or middle ear surgery.\*
- •7\)Subject has uncontrolled diabetes mellitus (HbA1c levels of 8\.0 percent or more).
- •8\)Subject has autoimmune diseases.
- •9\)Subject has a history of malignancy or malignancy within 3 years prior to the time of consent.
- •10\)Subject has received any immunosuppressants.
Outcomes
Primary Outcomes
Not specified
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