UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022554 |
|---|---|
| Receipt number | R000025993 |
| Scientific Title | Sealing of lung air leaks by autologous tissue engineered dermal fibroblast sheets |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2018/12/03 13:49:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Sealing of lung air leaks by autologous tissue engineered dermal fibroblast sheets
Acronym
Sealing of lung air leaks by fibroblast sheets
Scientific Title
Sealing of lung air leaks by autologous tissue engineered dermal fibroblast sheets
Scientific Title:Acronym
Sealing of lung air leaks by fibroblast sheets
Region
| Japan |
Condition
Condition
Pneumothorax, Bullae, Benign lung tumors
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of transplanted autologous tissue engineered fibroblast sheets and the ability of sealing of lung air leaks by the cell sheets.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety of the autologous tissue engineered cell sheets
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
A minimum of skin tissue and peripheral blood required for fibroblast sheets is collected from a research participant. A fibroblast sheet is doubly transplanted on to the site of lung air leaks after a lung surgery.
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
1 A case of 20 years or older
2 The patients will undergo operation of lung resection and/or pleurectomy
3 A self-skin tissue is available for a cell processing without a functional invasive.
4 The functions of the main organs such as bone marrow, heart, liver, and kidney are kept. Within 2 weeks before registration, the criteria are follows.
1) White blood cell count >=3000mm3-<=12000mm3, 2) Neutrophil count >=1500mm3-<=5000mm3, 3) Hemoglobin >=8g/dL, 4) Platelet count >=50000mm3, 5) Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT); 2.5 times upper limit of normal in our hospital, 6) Creatinine; 1.5 times upper limit of normal in our hospital
5 A case that a document agreement by the person himself was provided about examination participation.
Key exclusion criteria
1 Patient with infectious disease (HBV, HCV, HIV, HTLV, syphilis)
2 Patients with the impossible of sealing of air leaks
3 Pregnancy and the possibility of the pregnancy
4 Patients with allergy (lidokin and antibiotics)
5 Patients with psychiatric diseases
6 Patients with skin diseases
7 Patients with severe or complicated medical conditions, not allowing participation into this protocol
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Kanzaki |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery I and Institute of Advanced Biomedical Engineering and Science
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
kanzaki@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Takagi |
Organization
Tokyo Women's Medical University
Division name
Institute of Advanced Biomedical Engineering and Science
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-5367-9945
Homepage URL
takagi.ryo@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | 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
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2018 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025993
