臨床研究等提出・公開システム

Scientific Title	Exploratory Study of ADR-002K for Heart Failure Patients with Ischemic Heart Disease who Undergo Coronary Artery Bypass Surgery
Public Title	Exploratory Study of ADR-002K for Heart Failure Patients with Ischemic Heart Disease who Undergo Coronary Artery Bypass Surgery

Contact for Scientific Queries	Name	Okawa Sumito
	Affiliation	ROHTO Pharmaceutical Co., Ltd.
	Address	20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo
	Telephone	+81-3-6832-6014
	E-mail	R-regenerative_medicine@rohto.co.jp
Contact for Public Queries	Name	Osawa Toshiyuki
	Affiliation	ROHTO Pharmaceutical Co., Ltd.
	Address	16th Nakanoshima Qross 4-3-51 Nakanoshima, Kita-ku, Osaka
	Telephone	+81-6-6447-8610
	E-mail	R-regenerative_medicine@rohto.co.jp

Recruitment status	Pending

Anticipated date of first enrollment		May. 14, 2025
Actual date of first enrollment
Target sample size		50
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who are clinically diagnosed heart failure with ischemic heart disease and receive CABG 2) Patients with a left ventricular ejection fraction of 40% or less before CABG 3) Others
	Exclusion Criteria	1) Patients who have a combination of cardiovascular disease such as severe organic valvular disease 2) Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator 3) Others
	Age Minimum	18age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Heart Failure Patients with Ischemic Heart Disease who Undergo Coronary Artery Bypass Surgery
Intervention(s)		Coronary Artery Bypass Surgery, ADR-002K
Health Condition(s) Keyword		Coronary Artery Bypass Surgery, Ischemic Heart Disease, Adipose-derived Mesenchymal Stem Cells
Intervention(s) Keyword
Health Condition(s) Code		D017202
Intervention(s) Code		D045164
Primary Outcome(s)		Heart Failure Event
Secondary Outcome(s)		1) Cardiac Function 2) QOL 3) Others

Primary Sponsor	ROHTO Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Institutional Rview 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
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none