UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006352 |
|---|---|
| Receipt number | 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 12:17:30 |
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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
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
rtanaka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicie Department of Plastic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007171
