UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017734 |
|---|---|
| Receipt number | R000020534 |
| Scientific Title | A clinical trial for the validation of safety and efficacy of the implant-type tissue-engineered cartilage using autologous cells. |
| Date of disclosure of the study information | 2015/06/18 |
| Last modified on | 2020/06/17 10:43:16 |
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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
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
pochi-tky@umin.net
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020534
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