A clinical trial for the validation of safety and efficacy of the implant-type tissue-engineered cartilage using autologous cells. - A clinical trial of the implant-type tissue-engineered cartilage using autologous cells.

The University of Tokyo Hospital0 sites2 target enrollmentJune 18, 2015

ConditionsSevere nasal deformity in orofacial cleft, that needs nasal augmentation and nasal tip correction

Overview

Phase: 未知
Intervention: Not specified
Conditions: Severe nasal deformity in orofacial cleft, that needs nasal augmentation and nasal tip correction
Sponsor: The University of Tokyo Hospital
Enrollment: 2
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 18, 2015

End Date

March 26, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

The University of Tokyo Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

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.