臨床研究等提出・公開システム

Scientific Title	Follow-up study of human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids in patients with severe heart failure, secondary to ischemic heart disease, undergoing coronary artery bypass grafting
Public Title	Follow-up study of human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids in patients with severe heart failure, secondary to ischemic heart disease, undergoing coronary artery bypass grafting

Contact for Scientific Queries	Name	Kaneko Takehiko
	Affiliation	Heartseed Inc
	Address	1-2-3, Shibaura, Minato-ku Tokyo
	Telephone	+81-3-6380-1068
	E-mail	chiken@heartseed.jp
Contact for Public Queries	Name	Toiawase Madoguchi
	Affiliation	Heartseed Inc
	Address	1-2-3, Shibaura, Minato-ku Tokyo
	Telephone	+81-3-6380-1068
	E-mail	chiken@heartseed.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 13, 2024
Actual date of first enrollment
Target sample size		10
Study Type		Interventional
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	Subjects who participated in the HS-001-01 study and were transplanted with HS-001CS and who were able to obtain voluntary consent in writing for inclusion in this clinical trial.
	Exclusion Criteria	Patients judged by the Investigator to be ineligible shall not be included in the Clinical Trial.
	Age Minimum	20age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Heart failure with ischemic heart disease
Intervention(s)		To take immunosuppressant tacrolimus or other immunosuppressant
Health Condition(s) Keyword		Ischemic heart disease, Heart Failure, Coronary artery bypass grafting (CABG)
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety
Secondary Outcome(s)		Safety

Primary Sponsor	Heartseed Inc

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tokyo Womens Medical University Institutional Review Board
Address	8-1,Kawada-cho,Shinjuku-ku,Tokyo,Japan, Tokyo
Telephone	+81-3-3353-8111
E-Mail
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none