Severe nasal deformity in orofacial cleft, that needs nasal augmentation and nasal tip correction
Conditions
Interventions
Transplantation of the implant-type tissue-engineered cartilage using autologous cells
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of criteria below will be included. 1. Patients with nasal deformities in orofacial cleft, that needs nasal augmentation and nasal tip correction 2. Patients who can keep the schedule of observation and investigation described in the protocol of this clinical trial. 3. Patients of age 20 or older (on obtainment of informed consent) 4. Patients who can understand the content of this clinical trial and agree to the written informed consent.
Exclusion criteria
Exclusion criteria: 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 noses. 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 FSI2007. 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence and details of all adverse events, those related to the investigative product, and defect of the product are evaluated to validate safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| Indices such as the distance from nasal tip to nasal root, the area of nose, evaluation of the appearance of whole face and nose/mouth, cosmetic satisfaction, change in daily activity, change in depressiveness, evaluation of the cartilage collection site, evaluation of nasal curvature, evaluation of hardness of the transplantation site, and evaluation of fixing and cartilage maturation by MRI are used exploratory to evaluate the efficacy. | — |
Countries
Japan
Contacts
Public ContactKazuto Hoshi
The University of Tokyo Hospital The Department of Oral-Maxillofacial Surgery and Orthodontics
Outcome results
None listed