UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of treatment for severe heart failure using autologous myoblast sheet
Title of the study (Brief title)	Autologous myoblast sheets transplantation therapy for cardiomyopathy
Region	Japan

Condition
Condition	Dilated cardiomyopathy, Ischemic cardiomyopathy
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety, feasibility, and efficacy study of autologous myoblast sheet for cardiomyopasthy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Improvement of LV ejection fraction
Key secondary outcomes	1) Feasibility of myoblast sheet implantation 2) Improvement of regional function 3) LV reverse remodeling 4) Improvement of symptoms and grade of heart failure 5) Adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Behavior,custom Maneuver
Interventions/Control_1	Culture of autologous skeletal myoblasts and engineering myoblast sheets. Transplantation of myoblast sheets to heart
Interventions/Control_2	Patients with maximal medical and surgical treatment
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Dilated cardiomyopathy and ischemic cardiomyopathy 2) NYHA Class II,III, IV 3) Ejection fraction<35%
Key exclusion criteria	1) Severe skeletal muscle disease 2) Severe infection 3) Alcoholic or drug addiction in recent six months 4) Malignancy 5) Virus infection (HIV, HBV, HCV,HTLV) 6) Pregnancy 7) Others
Target sample size	40

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	06-6879-3154
Email	sawa@surg1.med.osaka-u.ac.jp

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 Disease
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	大阪大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 21 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 09 Month 17 Day
Anticipated trial start date	2014 Year 01 Month 22 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 01 Month 21 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=R000015089