Patients of cleft lip and palate, suffering from severe nasal deformity that needs nasal augmentation and nasal tip correction
Conditions
Interventions
Transplantation of implant-type tissue-engineered cartilage
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study patients are to meet all the criteria described below: 1) Patients of cleft lip and palate who suffer from severe nasal deformity that needs nasal augmentation and nasal tip correction, and also have bilateral/lateral deformity in nasal septum. 2) Age: over 20 and below 40-years-old 3) Body weight: over 40 kg
Exclusion criteria
Exclusion criteria: Patients who conflict with the conditions listed below will be excluded from this research: 1) Patients who are classified as Class 3 or higher in the ASA physical status by the American Society of Anesthesiologists 2) Patients who possess or are possible to possess malignant neoplasm 3) Patients with diabetes melitus 4) Patients who are possible to possess sepsis or bacteremia 5) Patients who possess infections that are possible to recur around the surgical sites (ear or nose) 6) Patients who have received surgical treatments on the surgical sites (nose or cartilage) within one year before the operation 7) Female patients who are pregnant or are possible to be pregnant, and who are lactating 8) Patients who are possible to suffer from syphilis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or adult T cell leukemia 9) Patients who suffer or suffered from autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, Hashimoto's thyroiditis, Graves' disease, polyarteritis, scleroderma, ulcerative colitis, Crohn's disease, Sjogren's syndrome, Reiter's syndrome, or mixed connective tissue disease, and patients whose family suffer or suffered from those diseases 10) Patients who have past history of anaphylactic reaction 11) Patients who possess or are possible to possess past history of hypersensitivity or an allergy to collagen preparations, lactic acid polymer preparations, fibroblast growth factor (FGF) preparations, insulin preparations, penicillin, or streptomycin The list of 12) to 14) have been omitted here because of space limitation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be confirmed based on the incidence of adverse events including pain, infection or graft failure requiring the removal of tissue-engineered cartilage after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness will be additionally assessed based on exploratory evaluation indicators, such as satisfaction level of patients, activity of daily living, improvement of facial features, less-invasiveness at donor sites and formation of regenerated cartilage. | — |
Countries
Japan
Contacts
Public ContactKazuto Hoshi
The University of Tokyo Hospital Division of Tissue Engineering
Outcome results
None listed