UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001859 |
|---|---|
| Receipt number | R000002238 |
| Scientific Title | Invention of new strategy against endstage ischemic heart failure using left ventricular assist device and autologous cell transplantation |
| Date of disclosure of the study information | 2009/04/07 |
| Last modified on | 2009/04/07 19:43:13 |
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Basic information
Public title
Invention of new strategy against endstage ischemic heart failure using left ventricular assist device and autologous cell transplantation
Acronym
Invention of new strategy against endstage ischemic heart failure using left ventricular assist device and autologous cell transplantation
Scientific Title
Invention of new strategy against endstage ischemic heart failure using left ventricular assist device and autologous cell transplantation
Scientific Title:Acronym
Invention of new strategy against endstage ischemic heart failure using left ventricular assist device and autologous cell transplantation
Region
| Japan |
Condition
Condition
endstage ischemic heart failure requiring left ventricular assist device
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and feasibility of the combination cell therapy in patients with severe ischemic cardiomyopathy who required left ventricular assist system (LVAS) implantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
Cardiac function, such as left ventricular ejection fraction, diastolic color kinesis index and BNP levels, and histological ezamination were evaluated.
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
LVAS implantation and cell transplantation
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) patients who are in severe heart failure of NYHA class IV and do not respond to maximum medical and surgical treatment due to ischemic cardiomyopathy
2) patients who understand the purpose of this study and have family support.
3) patients who can sign the agreement to the informed concent
Key exclusion criteria
The major exclusion criteria consists of peripheral muscular dystrophy, malignancies, pregnancy, alcoholic, and positive serologic test results for human immunodeficient virus, hepatitis, human T lymphotrophic virus type 1 and syphilis.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sawa |
Organization
Osaka University, Graduate School of Medicine
Division name
Division of Crdiovascular Surgery, Department of Surgery
Zip code
Address
2-2 Yamadaoka Suita City, Osaka
TEL
06-6879-3154
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Fujita |
Organization
Osaka University, Graduate School of Medicine
Division name
Division of Crdiovascular Surgery, Department of Surgery
Zip code
Address
2-2 Yamadaoka Suita City, Osaka
TEL
06-6879-3154
Homepage URL
tomofujita@nifty.com
Sponsor or person
Institute
Osaka University, Graduate School of Medicine, Division of Crdiovascular Surgery, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2009 | Year | 04 | Month | 07 | 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
Completed
Date of protocol fixation
| 2004 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 07 | Day |
Last modified on
| 2009 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002238
