UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy
Acronym	Clinical trial of human (allogeneic) iPS cell-derived cardiomyocyte sheet for severe cardiomyopathy
Scientific Title	Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy
Scientific Title:Acronym	Clinical trial of human (allogeneic) iPS cell-derived cardiomyocyte sheet for severe cardiomyopathy
Region	Japan

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

Objectives
Narrative objectives1	We aim to examine the feasibility, safety assessment and transition of heart function of new regenerative therapy based on human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation for patients with severe ischemic cardiomyopathy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Feasibility and safety evaluation of human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation (presence / absence, type, severity, frequency of expression and duration of adverse event accompanying iPS cell derived-cardiomyocyte sheet transplantation)
Key secondary outcomes	Evaluation of LVEF, left ventricular remodeling, severity of symptoms of heart failure from protocol treatment to 1 year after protocol treatment

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	Other
Interventions/Control_1	Human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation
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	18 years-old <=
Age-upper limit	79 years-old >
Gender	Male and Female
Key inclusion criteria	1)Ischemic cardiomyopathy 2)NYHA Class III,IV 3)Patients who can not expect symptomatic improvement with standard treatment for target disease. To be recognized by the third party committee with experts 4)Ejection fraction<=35%
Key exclusion criteria	1)Severe infection. 2)Alcoholic or drug addiction in recent six months 3)Malignancy 4)Virus infection(HIV,HBV,HCV,HTLV) 5)Pregnancy 6)Hypersensitivity 7)Contraindication(Immunosuppressant) 8)Others
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Yoshiki Middle name Last name Sawa
Organization	Osaka University Graduate School of Medicine
Division name	Cardiovascular surgery
Zip code	565-0871
Address	2-2, Yamadaoka, Suita city, Osaka
TEL	06-6879-3154
Email	sawakenkyu@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Miyagawa
Organization	Osaka University Graduate School of Medicine
Division name	Cardiovascular surgery
Zip code	565-0871
Address	2-2, Yamadaoka, Suita city, Osaka
TEL	06-6879-3154
Homepage URL
Email	miyagawakenkyu@surg1.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The first certified special committee for regenerative medicine, Osaka University
Address	2-2, Yamadaoka, Suita city, Osaka
Tel	06-6210-8293
Email	nintei@dmi.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	PA8170002
Org. issuing International ID_1	Ministry of Health, Labour and Welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 15 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	Terminated
Date of protocol fixation	2018 Year 06 Month 05 Day
Date of IRB	2018 Year 03 Month 09 Day
Anticipated trial start date	2019 Year 08 Month 11 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 14 Day
Last modified on	2020 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037108