UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	Development of implant-type tissue-engineered cartilage for patients with nasal deformity in cleft lip and palate
Scientific Title	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
Scientific Title:Acronym	Development of implant-type tissue-engineered cartilage for patients with nasal deformity in cleft lip and palate
Region	Japan

Condition
Condition	Patients of cleft lip and palate, suffering from severe nasal deformity that needs nasal augmentation and nasal tip correction
Classification by specialty	Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to conduct clinical application of implant-type tissue-engineered cartilage on a few patients of cleft lip and palate, and confirm its safety. The effectiveness will be additionally verified through exploring the evaluation indicators.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

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	Device,equipment
Interventions/Control_1	Transplantation of implant-type tissue-engineered cartilage
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	40 years-old >
Gender	Male and Female
Key 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
Key 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.
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuto Hoshi
Organization	The University of Tokyo Hospital
Division name	Division of Tissue Engineering/Department of Oral and Maxillofacial Surgery
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL	03-5800-8669
Email	pochi-tky@umin.net

Public contact
Name of contact person	1st name Middle name Last name Kazuto Hoshi
Organization	The University of Tokyo Hospital
Division name	Division of Tissue Engineering
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL	03-5800-9891
Homepage URL
Email	pochi-tky@umin.net

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	The University of Tokyo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2011 Year 04 Month 22 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
Results
Results date posted
Results Delayed
Results Delay Reason
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	2011 Year 03 Month 28 Day
Date of IRB	2011 Year 03 Month 15 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 04 Month 20 Day
Last modified on	2021 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006488