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 |
Invention of new strategy against endstage ischemic heart failure using left ventricular assist device and autologous cell transplantation
Invention of new strategy against endstage ischemic heart failure using left ventricular assist device and autologous cell transplantation
Invention of new strategy against endstage ischemic heart failure using left ventricular assist device and autologous cell transplantation
Invention of new strategy against endstage ischemic heart failure using left ventricular assist device and autologous cell transplantation
Japan |
endstage ischemic heart failure requiring left ventricular assist device
Cardiovascular surgery |
Others
NO
To evaluate safety and feasibility of the combination cell therapy in patients with severe ischemic cardiomyopathy who required left ventricular assist system (LVAS) implantation.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Adverse events
Cardiac function, such as left ventricular ejection fraction, diastolic color kinesis index and BNP levels, and histological ezamination were evaluated.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
LVAS implantation and cell transplantation
18 | years-old | <= |
70 | years-old | > |
Male and Female
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
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.
6
1st name | |
Middle name | |
Last name | Yoshiki Sawa |
Osaka University, Graduate School of Medicine
Division of Crdiovascular Surgery, Department of Surgery
2-2 Yamadaoka Suita City, Osaka
06-6879-3154
1st name | |
Middle name | |
Last name | Tomoyuki Fujita |
Osaka University, Graduate School of Medicine
Division of Crdiovascular Surgery, Department of Surgery
2-2 Yamadaoka Suita City, Osaka
06-6879-3154
tomofujita@nifty.com
Osaka University, Graduate School of Medicine, Division of Crdiovascular Surgery, Department of Surgery
Osaka University
Self funding
Japan
NO
2009 | Year | 04 | Month | 07 | Day |
Unpublished
Completed
2004 | Year | 04 | Month | 01 | Day |
2004 | Year | 04 | Month | 01 | Day |
2007 | Year | 09 | Month | 01 | Day |
2008 | Year | 04 | Month | 01 | Day |
2009 | Year | 04 | Month | 01 | Day |
2009 | Year | 05 | Month | 01 | Day |
2009 | Year | 04 | Month | 07 | Day |
2009 | Year | 04 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002238
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |