UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000023911