UMIN-CTR Clinical Trial

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	2021 Year 01 Month 27 Day

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