臨床研究等提出・公開システム

Scientific Title	Japanese OMI treatment with Kit-positive cells for Enhanced Regeneration trial (JOKER trial)
Public Title	A clinical study to determine the safety and effectiveness of intracoronary infusion of autologous c-kit-positive cardiac stem cells in Japanese patients with ischemic cardiomyopathy. (JOKER trial)
Manager (representative manager when conducting as a multicenter joint research)	Isobe Mitsuaki

Contact for Scientific Queries	Name	Hosoda Toru
	Affiliation	Sakakibara Heart Institute
	Address	3-16-1 Asahi-cho, Fuchu-shi, Tokyo
	Telephone	+81-42-314-3111
	E-mail	thosoda@shi.heart.or.jp
Contact for Public Queries	Name	Shinoki Hiromi
	Affiliation	Sakakibara Heart Institute
	Address	3-16-1 Asahi-cho, Fuchu-shi, Tokyo
	Telephone	+81-42-314-3111
	E-mail	tiken@shi.heart.or.jp

Target sample size		6
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Adult with ability to provide informed consent. Left ventricular ejection fraction less than 40%. Scheduled for elective surgical revascularization within 2 months.
	Exclusion Criteria	Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis. Diabetic HbA1c greater than 8.5%. Pregnant women. Scheduled for additional interventions including ventriculoplasty.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic ischemic heart failure
Intervention(s) Code		Stem Cell Transplantation
Intervention(s) Keyword		Stem Cell Transplantation
Intervention(s)		Autologous intracoronary single infusion of 1,000,000 cardiac stem cells via cardiac catheter.
Health Condition(s) Code		Heart Failure
Health Condition(s) Keyword		Heart Failure
Primary Outcome(s)		Frequency and severity of adverse events (death, ventricular arrhythmia, infection, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism, etc.) at 1, 3, 6, 9, 12, 15, 18, 21, 24 months after the cell infusion.
Secondary Outcome(s)		Symptom by NYHA classification, NT-proBNP, electrocardiogram, chest X-ray, cardiopulmonary exercise test, cardiac function by echocardiogram and magnetic resonance imaging, viability evaluation by myocardial scintigraphy.

Anticipated date of first enrollment	Nov. 14, 2017
Actual date of first enrollment	Nov. 15, 2017
Recruitment status	Not Recruiting

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan research promotion society for cardiovascular disease
Secondary Sponsor	Not applicable

Name of Certified Review Board	Regenerative Medicine Diffusion Association Certified Committee for Regenerative Medicine
Address	1-13-1 Kachidoki, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-5547-0203
E-Mail	office@rdclinic.jp
Approval Status	Approval
Date of approval	Mar. 27, 2020

Secondary ID(s)	PB3170012
Issuing Authority	Kanto Shin-Etsu Welfare Office

Secondary ID(s)	UMIN000029959
Issuing Authority	University hospital Medical Information Network (UMIN)

Secondary ID(s)	NCT03351400
Issuing Authority	U.S. National Library of Medicine (NIH)

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