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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005472
Receipt No. R000006488
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
Date of disclosure of the study information 2011/04/22
Last modified on 2018/04/27

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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 No longer recruiting
Date of protocol fixation
2011 Year 03 Month 28 Day
Date of IRB
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
2018 Year 04 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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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