UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of new strategy for severe heart failure using aoutologous myoblast sheets.
Title of the study (Brief title)	Autologus myoblast sheets transplantation therapy for ischaemic and dilated cardiomyopathy.
Region	Japan

Condition
Condition	ischaemic cardiomyopathy, dilated cardiomyopathy
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 against ischaemic or 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.
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	ischaemic or dilated cardiomyopathy, NYHA Class III and Class IV, Ejection fraction <35%,
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	16

Research contact person
Name of lead principal investigator	Yoshiki Sawa
Organization	Osaka University Graduate school of medicine
Division name	Cardiovascular surgery
Address	2-2 Yamadaoka, Suita, Osaka
TEL
Email

Public contact
Name of contact person	Shigeru Miyagawa
Organization	Osaka University Graduate school of medicine
Division name	Cardiovascular surgery
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3154
Homepage URL
Email	miyagawa@surg1.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate school of medicine, Cardiovascular surgery
Institute
Department

Funding Source
Organization	Research on Measures for Intractable Diseases
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2010 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 11 Month 04 Day
Anticipated trial start date	2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 03 Month 01 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003959