UMIN-CTR Clinical Trial

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

Cardiovascular disease

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism
Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Profile of surface antigens in adipose-derived MSCs
Regenerative capacity of cultured MSCs (in vitro)

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

金沢大学附属病院 (石川県)

Date of disclosure of the study information

2016

Year

01

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

Registered date

2016

Year

01

Month

27

Day

Last modified on

2020

Year

02

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023911