Hard tissue reconstruction in middle ear cholesteatoma surgery using tissue-engineered cartilage
- Conditions
- Cholesteatoma (acquired or congenital) of moderate to severe grade
- Registration Number
- JPRN-jRCTb032190216
- Lead Sponsor
- Ito Ken
- Brief Summary
Primary and secondary endpoints were attained in all of the 3 included cases (ID: OTO01, OTO02, and OTO04) on the evaluation 6 months after surgery. To date, no serious adverse effect owing to the regenerative medicine has been observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 3
1. Age: 20-69 years old (both at informed consent and at surgery)
2. Patient with cholesteatoma (acquired or congenital) of moderate to severe grade
3. Patient from whom written informed consent is acquired for participating in the present clinical research
1. Continuous otorrhea caused by MRSA, multi-drug resistant Pseudomonas aeruginosa, etc.
2. When anticoagulant drugs cannot be discontinued
3. Diabetes mellitus with poor control
4. Severe disorder in circulatory, respiratory, hepatic, renal, or hematologic organs
5. Severe allergic disease
6. Inability to use post-operative antibiotics because of drug allergy
7. Malignant disease in internal organs, blood, etc. (excluding completely cured one)
8. Addict of narcotic drugs, alcohol, etc.
9. Other complications that may increase susceptibility to infection
10. Participation in other clinical studies or trials, presently or during 6 months before informed consent
11. Pregnancy or breast-feeding presently, or women who do not agree with anticonception through 6 months after surgery
12. Possibility of syphilis, hepatitis B, hepatitis C, human immunodeficiency virus infection, or human T cell leukemia virus infection
13. Present or past affection, including members of family, of autoimmune disease, such as rheumatic arthritis, psoriatic arthritis, systemic lupus erythematodes, discoid lupus erythematodes, dermatomyositis, polymyositis, chronic thyroiditis, Basedow's disease, polyarteritis, scleroderma, ulcerative colitis, Crohn's disease, Sjogren's syndrome, Reiter's syndrome, mixed connective tissue disease, and relapsing polychondritis
14. History or possibility of hypersensitivity or allergy to collagen preparation, lactic acid-based polymer preparation, fibroblast growth factor (FGF) preparation, insulin preparation, penicillin, streptomycin, amphotericin B, or dexamethasone
15. Use, within 3 months of autologous blood donation, of FGF-2 preparation, parathormone (PTH) preparation, insulin-like growth factor-I (IGF-I) preparation, insulin preparation, growth hormone preparation, female sex hormone preparation (except cosmetics), male hormone preparation, IL-1 receptor antagonist preparation, thyroid hormone preparation, vitamin D preparation (except supplements), or steroid preparation (except medicine for external application)
16. Positive result of intracutaneous test for atelocollagen
17. Others judged inappropriate by the doctors in charge of the study
18. History of hypersensitivity to the ingredient of Beriplast (fibrin glue) or to preparations using cow lungs raw materials (aprotinin, etc.)
19. Present treatment with coagulation accelerator (snake poison preparation), antifibrinolytic agent, or aprotinin preparation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Retraction of external auditory canal evaluated by CT at 6 months after surgery, compared to the state at 3 months after surgery. (criterion: preservation of 65% or more at 6 months compared to 100% at 3 months)
- Secondary Outcome Measures
Name Time Method Infection and necrosis of the implanted cartilage (excluding that caused by recurrence of cholesteatoma)