臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 11, 2019
Last modified on	April. 18, 2023
Trial ID	jRCT2053190081

Scientific Title	Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy
Public Title	Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy

Contact for Scientific Queries	Name	Miyagawa Shigeru
	Affiliation	Osaka university hospital
	Address	2-15, Yamadaoka, Suita, Osaka
	Telephone	+81-6-6879-3154
	E-mail	saisentan@tissue.med.osaka-u.ac.jp
Contact for Public Queries	Name	Kawamura Takuji
	Affiliation	Osaka university hospital
	Address	2-15, Yamadaoka, Suita, Osaka
	Telephone	+81-6-6879-3154
	E-mail	saisentan@tissue.med.osaka-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 11, 2019
Actual date of first enrollment		Jan. 10, 2020
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	1) Ischemic cardiomyopathy 2) NYHA class III, IV 3) Patients who can not expect symptomatic improvement with standard treatment for target disease. To be recognized by the third party committee with experts. 4) Ejection fraction <= 35%
	Exclusion Criteria	1) Autoimmune disease 2) Allergic or hypersensitive to the immunosuppressant 3) Severe infection 4) Persistent shock due to worsening heart failure 5) Irreversible organ failure other than heart 6) Maignancy 7) Pregnancy 8) Alcoholic or drug addiction in recent six months 9) Allergies or hypersensitivity to animals from which raw materials used 10) Severe pulmonary hypertension
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ischemic cardiomyopathy
Intervention(s)		Human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		D017202
Intervention(s) Code		D017690
Primary Outcome(s)		Number of patients with improved LVEF compared with preoperative at 26 weeks after transplantation
Secondary Outcome(s)		1) Number of responders at 26 and 52 weeks after transplantation 2) Evaluation of the following changes before 26 and 52 weeks after transplantation (1) LVEF (2) Left ventricular remodeling (3) Severity of heart failure (4) Rejections (5) Others

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Cuorips Inc.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Instisutional review board of Osaka university hospital
Address	2-15, Yamadaoka, Suita, Osaka
Telephone	+81-6-6210-8290
E-Mail	jim-chiken@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 28, 2019

Name of Certified Review Board	Institutional Review Board for Kyushu University Hospital
Address	3-1-1, Maidashi, Higashi-ku, Osaka
Telephone	+81-92-642-5774
E-Mail
Approval Status	Approval
Date of approval	Sept. 28, 2019

Name of Certified Review Board	Tokyo Womens Medical University Institutional Review Board
Address	8-1,Kawada-cho,Shinjuku-ku, Osaka
Telephone	+81-3-3353-8111
E-Mail	chiken.bm@twmu.ac.jp
Approval Status	Approval
Date of approval	Sept. 28, 2019

Plan to share IPD	Yes
Plan description	The deidentified individual subject data will be used for conference presentations, research article,or both.If it is provided to the sponsor, it will be shared based on the contract.

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
8	April. 18, 2023	(this page)	Changes
7	Dec. 26, 2022	Detail	Changes
6	Aug. 09, 2022	Detail	Changes
5	Nov. 22, 2021	Detail	Changes
4	April. 22, 2021	Detail	Changes
3	June. 01, 2020	Detail	Changes
2	Dec. 12, 2019	Detail	Changes
1	Dec. 11, 2019	Detail

List of change history