臨床研究等提出・公開システム

Date of registration	Aug. 30, 2016
Last modified on	Sept. 06, 2022
Trial ID	jRCT1080223307

Scientific Title	Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM- 001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease
Public Title	Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM- 001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Metcela Inc.
	Address
	Phone Number
	E-mail Address	info@j-rm.com

Contact for Public Queries	Name
	Contact Name for Public Queries	Metcela Inc.
	Address
	Phone Number
	E-mail Address	info@j-rm.com

Recruitment Status	recruiting

Date of First Enrolment		Aug. 22, 2016
Target Sample Size		40
Study Type		Interventional
Study Design	Study Design	multicenter, randomized, standard-of-care controlled, single-blind, parallel-group
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Main inclusion criteria: - Functional single ventricle patient who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery - Ejection fraction (%) by echocardiography =< 55%
	Exclusion Criteria	Main exclusion criteria: - Known medical history of cardiogenic shock - Lethal, uncontrollable arrhythmia - Complication of coronary artery disease - Eisenmenger syndrome - Complication of brain dysfunction due to circulatory failure - Malignant neoplasm - Complication of severe neurologic disorder - Severe pulmonary embolism or pulmonary hypertension - Severe renal failure - Multiple organ failure - Active infection (including endocarditis) - Sepsis - Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury)
	Minimum Age	No limit
	Maximum Age	6age old under
	Gender	Both
Health Condition or Problem Studied		Functional single ventricle
Intervention(s)		investigational material(s) Generic name etc : JRM-001 INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : 3x 10^5 cells/kg, single treatment, intracoronary control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy confirmatory Ejection fraction assessed by cardiac MRI
Secondary Outcome		safety efficacy confirmatory Cardiac function assessed by echocardiograms and cardiac catheterization, heart failure index, QOL index etc.

Primary Sponsor	Metcela Inc.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	May. 17, 2016

Secondary ID No.	JapicCTI-163362
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Sept. 06, 2022	(this page)	Changes
3	July. 07, 2021	Detail	Changes
2	Dec. 25, 2020	Detail	Changes
1	Aug. 30, 2016	Detail

List of change history