UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000000660
Receipt No. R000000797
Scientific Title Development of new strategy for end stage dilated cardiomyopathy, a combination of left ventricular assist device and aoutologous myoblast sheets
Date of disclosure of the study information 2007/04/01
Last modified on 2011/11/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Development of new strategy for end stage dilated cardiomyopathy, a combination of left ventricular assist device and aoutologous myoblast sheets
Acronym A combination of left ventricular assist device and aoutologous myoblast sheets for end stage dilated cardiomyopathy
Scientific Title Development of new strategy for end stage dilated cardiomyopathy, a combination of left ventricular assist device and aoutologous myoblast sheets
Scientific Title:Acronym A combination of left ventricular assist device and aoutologous myoblast sheets for end stage dilated cardiomyopathy
Region
Japan

Condition
Condition End stage dilated cardiomyopathy patients who need LVAS
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of establishment of the methods utilizing aoutologous myoblast sheets cultured from skeletal muscle in the combination with left ventricular assist system (LVAS) against end stage dilated cardiomyopathy. The safety and the efficacy are tested.
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 Caridac function

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 Device,equipment Behavior,custom
Maneuver
Interventions/Control_1 Culture of autologous skeltal myoblasts and engineering myoblast sheets. Transplantation of the myoblast sheets to the heart in the combination with LVAS implantation.
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
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria End stage dilated cardiomyopathy
Requiring LVAS
Key exclusion criteria Severe skeletal muscle disease
Cancer
Severe infection
Alcoholic or drug addiction in recent six months
Pregnancy
Others (doctors dicision)
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 Cardiovascular 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 Goro Matsumiya
Organization Osaka University Graduate school of medicine
Division name Cardiovascular surgery
Zip code
Address 2-2 Yamadaoka Suita city, Osaka
TEL 06-6879-3154
Homepage URL
Email matsumg@surg1.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate school of medicine, Cardiovascular surgery
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
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
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 Preinitiation
Date of protocol fixation
2006 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2008 Year 08 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 29 Day
Last modified on
2011 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000797

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.