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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017058
Receipt No. R000019780
Scientific Title Development of tissue-engineering mesothelial cell sheets by using human peritoneum
Date of disclosure of the study information 2015/04/06
Last modified on 2015/04/06

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Basic information
Public title Development of tissue-engineering mesothelial cell sheets by using human peritoneum
Acronym Development of tissue-engineering mesothelial cell sheets
Scientific Title Development of tissue-engineering mesothelial cell sheets by using human peritoneum
Scientific Title:Acronym Development of tissue-engineering mesothelial cell sheets
Region
Japan

Condition
Condition Gynecologic benign disease
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop tissue engineering mesothelial cell sheet by using human peritoneum and to investigate biological activity, including fibrinolysis, of the cell sheet in vitro.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Development of mesothelial 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
Device,equipment Maneuver
Interventions/Control_1 laparoscopic 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
50 years-old >=
Gender Female
Key inclusion criteria Patients with benign gynecologic dissease who are scheduled laparoscopic surgery
Key exclusion criteria patients with malignancy and pregnant patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Kumakiri
Organization Juntendo University Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kumakiri@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Kumakiri
Organization Juntendo University Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email kumakiri@juntendo.ac.jp

Sponsor
Institute Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization Juntendo University Faculty of Medicine, Department of Obstetrics and Gynecology
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 04 Month 06 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 Open public recruiting
Date of protocol fixation
2015 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 06 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
2015 Year 04 Month 06 Day
Last modified on
2015 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019780

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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