UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048538
Receipt No. R000055289
Scientific Title Study of isolation culture and functions as transplanted cells in human cardiac stem cells
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/30

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Basic information
Public title Study of isolation culture and functions as transplanted cells in human cardiac stem cells
Acronym Study of isolation culture and functions as transplanted cells in human cardiac stem cells
Scientific Title Study of isolation culture and functions as transplanted cells in human cardiac stem cells
Scientific Title:Acronym Study of isolation culture and functions as transplanted cells in human cardiac stem cells
Region
Japan

Condition
Condition Heart disease
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify whether it is possible to isolate and culture human cardiac stem cells from atrial muscles of patients undergoing heart surgery.
Basic objectives2 Others
Basic objectives -Others To consider functions as transplanted cells of human cardiac stem cells.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To verify whether it is possible to isolate and culture human cardiac stem cells from atrial muscles of patients undergoing heart surgery.
Key secondary outcomes To consider functions as transplanted cells of human cardiac stem cells.

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 1. Patients over the age of 20.
2. Regardless of patient gender.
3. Limited to research for which consent has been obtained from the individual.
4. Patients participating in other clinical studies can also participate in this study.
Key exclusion criteria 1. Patients who are deemed inappropriate as a research subject
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kimikazu
Middle name
Last name Hamano
Organization Yamaguchi University
Division name Department of Surgery and Clinical Science
Zip code 7558505
Address 1-1-1 Minami-kogushi, Yamaguchi, Ube, Japan
TEL 0836-22-2261
Email cres-sg1@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Ueno
Organization Yamaguchi University
Division name Department of Surgery and Clinical Science
Zip code 7558505
Address 1-1-1 Minami-kogushi, Yamaguchi, Ube, Japan
TEL 0836-22-2261
Homepage URL
Email cres-sg1@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization Yamaguchi University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagasaki University
Name of secondary funder(s) Nagasaki University

IRB Contact (For public release)
Organization Yamaguchi University Institutional Review Board
Address 1-1-1 Minami-kogushi, Yamaguchi, Ube, Japan
Tel 0836-22-2428
Email clin_res@yamaguchi-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

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 01 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
2022 Year 07 Month 06 Day
Date of IRB
2022 Year 07 Month 27 Day
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information age at surgery, gender, NYHAgrade, heart function, high blood pressure, diabetes, history of hyperlipidemia and therapeutic drugs, ANP, BNP, Cr, eGFR, Hb, smoking history, history of coronary artery disease.

Management information
Registered date
2022 Year 08 Month 01 Day
Last modified on
2022 Year 07 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055289

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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