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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032989
Receipt No. R000037108
Scientific Title Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy
Date of disclosure of the study information 2018/06/15
Last modified on 2019/06/15

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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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 05 Day
Date of IRB
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
2019 Year 06 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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