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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025233
Receipt No. R000029023
Scientific Title Effects of intravenous autologous bone marrow derived mesenchymal stem cells in patients with chronic heart failure
Date of disclosure of the study information 2017/01/01
Last modified on 2019/06/17

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Basic information
Public title Effects of intravenous autologous bone marrow derived mesenchymal stem cells in patients with chronic heart failure
Acronym Intravenous bone marrow derived mesenchymal stem cells for chronic heart failure
Scientific Title Effects of intravenous autologous bone marrow derived mesenchymal stem cells in patients with chronic heart failure
Scientific Title:Acronym Intravenous bone marrow derived mesenchymal stem cells for chronic heart failure
Region
Japan

Condition
Condition chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 efficacy and safety of intravenous autologous bone marrow derived mesenchymal stem cells in patients with chronic heart failure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of left ventricular ejection fraction on echocardiography
Key secondary outcomes change of BNP and high sensitive troponin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Culture of autologous bone marrow derived mesenchymal stem cells and intravenous injection of cultured cells
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. NYHA II or III, LVEF less than 45%
2. BNP more than 50 pg/ml
3. Receiving medical therapy including ACE inhibitor and be-ta blocker for more than 12 months
Key exclusion criteria 1. Unstable heart failure
2. Patients with unstable angina
3. Current cardiac surgery and device therapy
4. Life expectancy less than 6 months
5. Severe liver and kidney failure

Target sample size 8

Research contact person
Name of lead principal investigator
1st name Yukihito
Middle name
Last name Sato
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Cardiology
Zip code 660-8550
Address 2-17-77, Higashinaniwa-cho, Amagasaki, Hyogo, Japan 660-8550
TEL 06-6480-7000
Email cardioys@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yukihito
Middle name
Last name Sato
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Cardiology
Zip code 660-8550
Address 2-17-77, Higashinaniwa-cho, Amagasaki, Hyogo, Japan 660-8550
TEL 06-6480-7000
Homepage URL
Email cardioys@kuhp.kyoto-u.ac.jp

Sponsor
Institute Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization none
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 Hyogo Prefectural Amagasaki General Medical Center
Address 2-17-77, Higashinaniwa-cho, Amagasaki, Hyogo, Japan 660-8550
Tel 06-6480-7000
Email cardioys@kuhp.kyoto-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 兵庫県立尼崎総合医療センター 

Other administrative information
Date of disclosure of the study information
2017 Year 01 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
2016 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2019 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 12 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029023

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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