UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000656 |
|---|---|
| Receipt number | R000000789 |
| Scientific Title | Clinical trial of mesenchymal stem cell transplantation for severe heart failure |
| Date of disclosure of the study information | 2007/04/01 |
| Last modified on | 2007/10/09 10:33:36 |
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Basic information
Public title
Clinical trial of mesenchymal stem cell transplantation for severe heart failure
Acronym
Mesenchymal stem cell transplantation for severe heart failure
Scientific Title
Clinical trial of mesenchymal stem cell transplantation for severe heart failure
Scientific Title:Acronym
Mesenchymal stem cell transplantation for severe heart failure
Region
| Japan |
Condition
Condition
Severe chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluatioin of safety and efficacy of mesenchymal stem cell transplantation for severe heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Ejection fraction
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
11/1/2003-5/31/2009
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Heart failure (ejection fraction of less than 40%) due to old myocardial infarction, dilated cardiomyopathy and other causes, and refractory to other drug therapies such as ACE inhibitors, beta-blockers and diuretcs
Key exclusion criteria
1. Any evidence of cancer or active infectious disease
2. Presence of proliferative diabetic retinopathy
3. Renal failure or hepatic failure
4. Any evidence for abnormality in peripheral blood
5. History of PTCA or CABG in the 6 months prior to study entry
6. History of acute myocardial infarctioin, unstable angina or myocarditis in the 6 months prior to study entry
7. Not pregnant
8. Presence of embolism in the left ventricle
9. Presence of aortic valve stenosis or aortic artificial valve
10. Very severe hear failure patients who can not endure invasive examination such as catheterization and bone marrow aspiration
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noritoshi Nagaya |
Organization
National Cardiovascular Center Research Institute
Division name
Department of Regenerative Medicine & Tissue Engineering
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan
TEL
06-6833-5012
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cardiovascular Center Research Institute
Division name
Department of Regenerative Medicine & Tissue Engineering
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2007 | Year | 04 | 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
No longer recruiting
Date of protocol fixation
| 2003 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | 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
| 2007 | Year | 03 | Month | 28 | Day |
Last modified on
| 2007 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000789
