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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020764
Receipt No. R000023911
Scientific Title Searching factors changing profile of adipose-derived Mesenchymal Stem Cells (MSC) in patients with cardiovascular disease.
Date of disclosure of the study information 2016/01/31
Last modified on 2020/02/18

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Basic information
Public title Searching factors changing profile of adipose-derived Mesenchymal Stem Cells (MSC) in patients with cardiovascular disease.
Acronym Characterizing of adipose-derived MSC in patients with cardiovascular disease.
Scientific Title Searching factors changing profile of adipose-derived Mesenchymal Stem Cells (MSC) in patients with cardiovascular disease.
Scientific Title:Acronym Characterizing of adipose-derived MSC in patients with cardiovascular disease.
Region
Japan

Condition
Condition Cardiovascular disease
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the profile of MSCs in adipose tissue of patients with cardiovascular disease.
Basic objectives2 Others
Basic objectives -Others Although adipose tissue is known to be an ideal cell source of mesenchymal stromal/stem cells (MSCs), a promising candidate for autologous cell therapy of cardiovascular disease, it is still unclear whether clinical patients maintain therapeutic MSCs in their adipose tissue. In this study, we investigate what impacts on yield of therapeutic MSCs in adipose tissue of patients with cardiovascular disease.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Profile of surface antigens in adipose-derived MSCs
Regenerative capacity of cultured MSCs (in vitro)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Eligible patients are adult male or female receiving elective cardiac surgery, including coronary artery bypass grafting (CABG), aortic valve replacement (AVR), cardiac device implantation, etc.
Key exclusion criteria Major exclusion criteria are emaciation, uncontrolled diabetes mellitus, maintenance hemodialysis, systemic inflammatory disease, malignant disease, and former irradiation therapy.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Takamura
Organization Kanazawa University Graduate School of Medical Science
Division name Disease Control and Homeostasis
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa 920-8641, Japan
TEL 81-76-265-2233
Email oto0803inoue@gmail.com

Public contact
Name of contact person
1st name Oto
Middle name
Last name Inoue
Organization Kanazawa University Graduate School of Medical Science
Division name Disease Control and Homeostasis
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa 920-8641, Japan
TEL 81-76-265-2233
Homepage URL
Email oto0803inoue@gmail.com

Sponsor
Institute Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science
Institute
Department

Funding Source
Organization Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science
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 The ethical committee of Kanazawa University Hospital
Address 13-1 Takara-machi, Kanazawa 920-8641, Japan
Tel 81-76-265-2100
Email rinri@adm.kanazawa-u.ac.jp

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 金沢大学附属病院 (石川県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 31 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 Enrolling by invitation
Date of protocol fixation
2014 Year 10 Month 26 Day
Date of IRB
2014 Year 11 Month 12 Day
Anticipated trial start date
2015 Year 04 Month 06 Day
Last follow-up date
2025 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a cross-sectional, observational study. Patients receiving cardiac surgery in this institution are enrolled and written informed consent for harvesting and using adipose tissue samples is obtained in all patients. After enrollment, clinical and laboratory variables are collected preoperatively, and whole data ware blinded for researchers who perform further experiments. Subcutaneous adipose tissue (1-2 g) is obtained from surgical incision. A part of adipose tissue (50-100 mg) is immediately separated and snap-frozen in liquid nitrogen to study gene expressions. SVF cells are isolated from remained tissue, and analyzed immunophenotypic profile by a flowcytometer. The remained cells after immunophenotyping are cultured and confirmed their proliferative capacity (Colony Forming Unit assay) and angiogenic potential (ELIZA, Tube formation assay, Cell therapy for mice hindlimb ischemia model).

Management information
Registered date
2016 Year 01 Month 27 Day
Last modified on
2020 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023911

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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