UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	exploratory study for dilated cardiomyopathy using YS0001
Title of the study (Brief title)	exploratory study for dilated cardiomyopathy using YS0001
Region	Japan

Condition
Condition	dilated cardiomyopathy
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objects are to evaluate the safety and validation of how to evaluate efficacy for autologous myoblast sheet
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LVEF change at 26 week from treatment
Key secondary outcomes

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
Interventions/Control_1	Culture of autologous skeletal myoblasts and engineering myoblast sheets. Transplantation of myoblast sheets to 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	19 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	DCM NYHA Class => iii Ejection fraction =<35%
Key exclusion criteria	skeletal muscle disease active infection (HIV,HBV,HCV,HTLV-1) Cancer within the past 5 years
Target sample size	6

Research contact person
Name of lead principal investigator	Yoshuki Sawa
Organization	Osaka University hospital
Division name	Cardiovascular surgery
Address	2-15 Yamadaoka, Suita, Osaka
TEL	06-6879-3154
Email	sawa@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person	Shigeru Miyagawa
Organization	Osaka University hospital
Division name	Osaka University hospital
Address	2-15 Yamadaoka, Suita, Osaka
TEL	06-6879-3154
Homepage URL
Email	miyagawa@surg1.med.osaka-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Surgery, Graduate School of medicine, Osaka University
Institute
Department

Funding Source
Organization	Japan Agency for medical research and development
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
Anticipated trial start date	2014 Year 11 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	2014 Year 12 Month 10 Day
Last modified on	2018 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016519