UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048538 |
|---|---|
| Receipt number | 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 | 2023/05/08 11:49:36 |
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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
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
cres-sg1@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
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
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
Open public recruiting
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
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
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 |
