臨床研究等提出・公開システム

Date of registration	July. 17, 2026
Last modified on	July. 31, 2026
Trial ID	jRCT1050260111

Scientific Title	Long-term follow-up of human (allogeneic) iPS cell-derived cardiomyocyte sheet transplantation.
Public Title	Long-term follow-up of human (allogeneic) iPS cell-derived cardiomyocyte sheet transplantation.

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

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 17, 2026
Target sample size		10
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients enrolled in either of the following studies who have received transplantation of this product -Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for dilated ischemic cardiomyopathy -Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for dilated cardiomyopathy
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Heart disease
Health Condition(s) Keyword		ischemic cardiomyopathy,dilated cardiomyopathy
Health Condition(s) Code		D006331
Primary Outcome(s)		Survival time
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 3) Changes and progression of cardiac function 4) Changes and progression of exercise tolerance 5) Changes and progression of laboratory values

Primary Sponsor	None

Name of Certified Review Board	Instisutional review board of Osaka university hospital
Address	2-2, Yamadaoka, Suita, Osaka
Telephone	+81-6-6210-8296
E-Mail	rinri@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	June. 10, 2026

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.

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	July. 31, 2026	(this page)	Changes
1	July. 17, 2026	Detail

List of change history