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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022554
Receipt No. 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

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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
Email 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
Email takagi.ryo@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025993

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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