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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001859
Receipt No. 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

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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
Email

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
Email tomofujita@nifty.com

Sponsor
Institute Osaka University, Graduate School of Medicine, Division of Crdiovascular Surgery, Department of Surgery
Institute
Department

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
Email

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
URL(English) https://upload.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


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