UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047335
Receipt number R000053954
Scientific Title A prospective observational study of Induced Pluripoteint Stem Cell-derived Cardiac Spheres transplantation EXTENDed Follow-up
Date of disclosure of the study information 2022/04/01
Last modified on 2024/04/01 10:03:58

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Basic information

Public title

A prospective observational study of Induced Pluripoteint Stem Cell-derived Cardiac Spheres transplantation EXTENDed Follow-up

Acronym

IPSCS-EXTEND study

Scientific Title

A prospective observational study of Induced Pluripoteint Stem Cell-derived Cardiac Spheres transplantation EXTENDed Follow-up

Scientific Title:Acronym

IPSCS-EXTEND study

Region

Japan


Condition

Condition

severe heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The safety of iPS cell-derived cardiomyocytes has not been established. The objective of the present study is to confirm the long-term safety (tumorogenicity, arrhythmia, etc.) and efficacy (improvement of left ventricular ejection fraction, left ventricular volume, etc.) after transplantation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Long-term safety of iPS cell-derived cardiomyocyte transplantation

Key secondary outcomes

Long-term efficacy of iPS cell-derived cardiomyocyte transplantation


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Subjects of the safety study of regenerative therapy with allogeneic induced pluripotent stem cell-derived cardiac spheres for severe heart failure (jRCTa032200189) approved by the Specified Certified Regenerative Medicine Committee.

Key exclusion criteria

Patients that do not meet the selection criteria.

Target sample size

3


Research contact person

Name of lead principal investigator

1st name Hideyuki
Middle name
Last name Shimizu

Organization

Keio University School of Medicine

Division name

Cardiovascular surgery

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku

TEL

03-3353-1211

Email

shimizu.md@gmail.com


Public contact

Name of contact person

1st name Yoshikazu
Middle name
Last name Kishino

Organization

Keio University School of Medicine

Division name

Cardiology

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku

TEL

03-5843-6702

Homepage URL


Email

ykishino@keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

HeartSeed

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine, Independent Ethics Committee

Address

35 Shinanomachi, Shinjuku-ku

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp


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

2022 Year 04 Month 01 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

Completed

Date of protocol fixation

2020 Year 02 Month 19 Day

Date of IRB

2021 Year 03 Month 30 Day

Anticipated trial start date

2022 Year 04 Month 01 Day

Last follow-up date

2029 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

https://jrct.niph.go.jp/latest-detail/jRCTa032200189


Management information

Registered date

2022 Year 03 Month 30 Day

Last modified on

2024 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053954


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name