UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005472 |
|---|---|
| Receipt number | 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 | 2021/10/27 00:42:55 |
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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
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
pochi-tky@umin.net
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006488
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