UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032989
Receipt number 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 2020/02/17 15:06:49

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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 or person

Institute

Osaka University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037108