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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006352
Receipt No. R000007171
Scientific Title Evaluation of hybrid ex vivo expanded diabetic peripheral blood endothelial progenitor cell function
Date of disclosure of the study information 2011/09/16
Last modified on 2012/10/29

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Basic information
Public title Evaluation of hybrid ex vivo expanded diabetic peripheral blood endothelial progenitor cell function
Acronym Evaluation of Diabetic EPC
Scientific Title Evaluation of hybrid ex vivo expanded diabetic peripheral blood endothelial progenitor cell function
Scientific Title:Acronym Evaluation of Diabetic EPC
Region
Japan

Condition
Condition Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism Plastic surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of diabetic endothelial progenitor function after hybrid ex vivo expansion culture.
Basic objectives2 Others
Basic objectives -Others Comparision to healty humans
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of diabetic endothelial progenitor function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 blood draw
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
80 years-old >=
Gender Male
Key inclusion criteria Non smoking diabetic patients seen at Juntendo University Internal Medicine department
Key exclusion criteria 1)Patient with hemoglobin A1c > 8.0
2)patient with hemodyalisis
3)patient with severe heart disease
4) patient with inflammatory or hematopoietic disease
5)patient with infection
6)patient with malignancy
7)patient who cannot take informed consent
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rica Tanaka
Organization Juntendo University School of Medicine
Division name Department of Plastic Surgery
Zip code
Address 2-1-1 Bunkyo-ku Hongo Tokyo Japna
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Rica Tanaka
Organization Juntendo University School of Medicine
Division name Department of Plastic Surgery
Zip code
Address 2-1-1 Bunkyo-ku Hongo Tokyo Japna
TEL 03-3813-3111
Homepage URL
Email rtanaka@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicie Department of Plastic Surgery
Institute
Department

Funding Source
Organization Funding program for next leading researchers
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 順天堂大学医学部形成外科学講座(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 16 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 Preinitiation
Date of protocol fixation
2011 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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
2011 Year 09 Month 15 Day
Last modified on
2012 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007171

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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