Investigator initiated clinical trial for tracheal reconstruction in patients with severe tracheal stenosis to confirm the safety and efficacy of the tissue-engineered tracheal cartilage using autologous cells
- Conditions
- Stenosis
- Registration Number
- JPRN-UMIN000032362
- Lead Sponsor
- The University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 3
Not provided
Patients who meet any of the following criteria are excluded. 1. Patients from whom sufficient blood cannot be collected (e.g. by recent blood donation). 2. ASA physical status 3 or worse. 3. Existing or possible malignancy. 4. Uncontrolled diabetes. 5. Possible sepsis. 6. Recurrent skin infection at the surgical sites, e.g. ears or trachea. 7. Patients who received, or will undergo surgeries at the operative sites within 1 year before surgery in this trial. 8. Females with existing or possible pregnancy, lactating, or who cannot agree with anticonception until 6 months after the transplantation of TKY2016. 9. Patients found positive in allergy test for atelocollagen 10. Possible syphilis, B/C hepatitis, HIV infection or adult T cell lymphoma. 11. Present, past or family histories of autoimmune diseases, e.g. rheumatoid arthritis, psoriatic arthritis, systemic/discoid lupus erythematosus, dermatomyositis, polymyositis, chronic thyroiditis, Graves' disease, polyartritis, scleroderma, ulcerous colitis, Crohn's disease, Sjogren's syndrome, Reiter syndrome, mixed connective tissue disease or relapsing polychondritis. 12. Histories of anaphylaxia. 13. Histories or possibilities of hypersensitivity or allergy to collagen products, lactic and glycolic acid polymer, fibroblast growth factor (FGF), insulin, penicillin or streptomycin. 14. Patients who used or will use FGF-2, parathyroid hormone, insulin-like growth factor-I, insulin, growth hormone, female hormones (except cosmetics), male hormones, interleukin-1 receptor antagonist, thyroid hormone, vitamin D (except supplements) or steroids (except topical products) 3 months before blood collection. 15. Patients who were in other clinical trials or clinical researches within 30 days before the obtainment of the consent. 16. Patients with mental diseases who cannot fill out survey slips. 17. Patients judged to be inappropriate as subjects of this trial by the responsive doctor or assigned doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence and details of all adverse events, those related to the investigative product, and defect of the product are evaluated to validate safety.
- Secondary Outcome Measures
Name Time Method Improvement of stenosis by sectional image of CT scan, evaluation of fixation and detachment of transplants and epithelial regeneration by ultrasonography, dynamic evaluation of stenosis by endoscopic examination, evaluation of ventilation function by respiratory function test, evaluation of respiratory function by arterial blood gas analysis, amount of change in everyday life operability by questionnaire on everyday life operability, cosmetic satisfaction, change in daily activity, change in depressiveness, evaluation of the cartilage collection site, and evaluation of fixing and cartilage maturation by MRI are used exploratory to evaluate the efficacy.