臨床研究等提出・公開システム

Japanese

Date of registration	June. 23, 2021
Last modified on	Mar. 11, 2024
Trial ID	jRCT2033210163

Scientific Title	A phase I/II 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 (LAPiS Study)
Public Title	A phase I/II 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 (LAPiS Study)

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	madoguchi Toiawase
	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. 23, 2021
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	Patients with ischemic heart disease undergoing CABG Patients with resting left ventricular ejection fraction (from 0.15 to 0.40) based on institutional assessment on either screening cardiac MRI or echocardiographic assessment New York Heart Association Class II, III or IV
	Exclusion Criteria	Patients who are candidates for cardiovascular surgery other than CABG (such as valvular heart surgery) Patients with the following complications Pulmonary hypertension, hypertension, diabetes, liver dysfunction, liver dysfunction, gait disturbance, active infection, active bleeding
	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)		During CABG with median sternotomy, human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids are transplanted to anterior, lateral, posterior and inferior using spheroid transplantation needle. Dose; 50 million or 150 million cells / body. After transplantation, subject take Immunosuppressant (taclolims, MMF and steroid).
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)		Heart function QOL

Primary Sponsor	Heartseed Inc.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tokyo Metropolitan Geriatric Medical Center Institutional Review Board
Address	35-2 Sakae-cho,Itabashi-ku, Tokyo, Tokyo
Telephone	+81-3-3964-1141
E-Mail	chiken@tmghig.jp
Approval Status	Approval
Date of approval	April. 12, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Mar. 11, 2024	(this page)	Changes
4	June. 04, 2022	Detail	Changes
3	Dec. 18, 2021	Detail	Changes
2	July. 19, 2021	Detail	Changes
1	June. 23, 2021	Detail

List of change history