臨床研究等提出・公開システム

Scientific Title	Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy (Follow-up trial)
Public Title	Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy (Follow-up trial)

Contact for Scientific Queries	Name	Miyagawa Shigeru
	Affiliation	Osaka university hospital
	Address	2-15, Yamadaoka, Suita, Osaka
	Telephone	+81-6-6879-3154
	E-mail	saisentan@tissue.med.osaka-u.ac.jp
Contact for Public Queries	Name	Kawamura Takuji
	Affiliation	Osaka university hospital
	Address	2-15, Yamadaoka, Suita, Osaka
	Telephone	+81-6-6879-3154
	E-mail	saisentan@tissue.med.osaka-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 22, 2022
Actual date of first enrollment
Target sample size		10
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who have undergone iPS cell derived-cardiomyocyte sheet (Clinical trial identification code:IPSOC-1) transplantation 2) Patients who can obtain concent to participate in this trial
	Exclusion Criteria	none
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ischemic cardiomyopathy
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		D017202
Intervention(s) Code
Primary Outcome(s)		Lifetime
Secondary Outcome(s)		1) Number and rate of clinical events of cardiac function such as death and hospitalization 2) Number and rate of tumor development events

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Cuorips Inc.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Instisutional review board of Osaka university hospital
Address	2-15, Yamadaoka, Suita, Osaka, Osaka
Telephone	+81-6-6210-8290
E-Mail	jim-chiken@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	April. 19, 2022

Plan to share IPD	Yes
Plan description	The deidentified individual subject data will be used for conference presentations, research article,or both.If it is provided to the sponsor, it will be shared based on the contract.

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 26, 2024	(this page)	Changes
1	June. 22, 2022	Detail

List of change history