UMIN-CTR Clinical Trial

Basic information
Public title	A clinical trial for the validation of safety and efficacy of the implant-type tissue-engineered cartilage using autologous cells.
Acronym	A clinical trial of the implant-type tissue-engineered cartilage using autologous cells.
Scientific Title	A clinical trial for the validation of safety and efficacy of the implant-type tissue-engineered cartilage using autologous cells.
Scientific Title:Acronym	A clinical trial of the implant-type tissue-engineered cartilage using autologous cells.
Region	Japan

Condition
Condition	Severe nasal deformity in orofacial cleft, that needs nasal augmentation and nasal tip correction
Classification by specialty	Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety, and collaterally, efficacy of FSI 2007, the implant-type tissue-engineered cartilage using autologous cells, are to be validated by applying it to patients of orofacial cleft with nasal deformities.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Occurrence and details of all adverse events, those related to the investigative product, and defect of the product are evaluated to validate safety.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Transplantation of the implant-type tissue-engineered cartilage using autologous cells
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	2

Research contact person
Name of lead principal investigator	1st name Kazuto Middle name Last name Hoshi
Organization	The University of Tokyo Hospital
Division name	The Department of Oral-Maxillofacial Surgery and Orthodontics
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL	03-3815-5411
Email	pochi-tky@umin.ac.jp

Public contact
Name of contact person	1st name Kazuto Middle name Last name Hoshi
Organization	The University of Tokyo Hospital
Division name	The Department of Oral-Maxillofacial Surgery and Orthodontics
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL	03-3815-5411
Homepage URL
Email	pochi-tky@umin.net

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, the University of Tokyo Hospital
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel	03-5800-8743
Email	crctky-office@umin.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	2
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	The application for approval is in progress.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 23 Day
Date of IRB	2015 Year 03 Month 19 Day
Anticipated trial start date	2015 Year 06 Month 18 Day
Last follow-up date	2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 29 Day
Last modified on	2020 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020534