Development of implant-type tissue-engineered cartilage for patients with nasal deformity in cleft lip and palate - implant-type tissue-engineered cartilage, which is made by applying autologous auricular chondrocytes to scaffolds consisting of atelocollagen hydrogel and poly-L-lactic acid (PLLA) porous body

Not Applicable

• Conditions: Patients of cleft lip and palate, suffering from severe nasal deformity that needs nasal augmentation and nasal tip correction

• Registration Number: JPRN-UMIN000005472
• Lead Sponsor: The University of Tokyo Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-22
• Study Completion: 2019-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.