Unique ID issued by UMIN | UMIN000032989 |
---|---|
Receipt number | R000037108 |
Scientific Title | Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy |
Date of disclosure of the study information | 2018/06/15 |
Last modified on | 2020/02/17 15:06:49 |
Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy
Clinical trial of human (allogeneic) iPS cell-derived cardiomyocyte sheet for severe cardiomyopathy
Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy
Clinical trial of human (allogeneic) iPS cell-derived cardiomyocyte sheet for severe cardiomyopathy
Japan |
Ischemic cardiomyopathy
Cardiovascular surgery |
Others
NO
We aim to examine the feasibility, safety assessment and transition of heart function of new regenerative therapy based on human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation for patients with severe ischemic cardiomyopathy.
Safety,Efficacy
Exploratory
Phase I,II
Feasibility and safety evaluation of human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation (presence / absence, type, severity, frequency of expression and duration of adverse event accompanying iPS cell derived-cardiomyocyte sheet transplantation)
Evaluation of LVEF, left ventricular remodeling, severity of symptoms of heart failure from protocol treatment to 1 year after protocol treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation
18 | years-old | <= |
79 | years-old | > |
Male and Female
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%
1)Severe infection.
2)Alcoholic or drug addiction in recent six months
3)Malignancy
4)Virus infection(HIV,HBV,HCV,HTLV)
5)Pregnancy
6)Hypersensitivity
7)Contraindication(Immunosuppressant)
8)Others
3
1st name | Yoshiki |
Middle name | |
Last name | Sawa |
Osaka University Graduate School of Medicine
Cardiovascular surgery
565-0871
2-2, Yamadaoka, Suita city, Osaka
06-6879-3154
sawakenkyu@surg1.med.osaka-u.ac.jp
1st name | Shigeru |
Middle name | |
Last name | Miyagawa |
Osaka University Graduate School of Medicine
Cardiovascular surgery
565-0871
2-2, Yamadaoka, Suita city, Osaka
06-6879-3154
miyagawakenkyu@surg1.med.osaka-u.ac.jp
Osaka University
Japan Agency for Medical Research and Development
Japanese Governmental office
The first certified special committee for regenerative medicine, Osaka University
2-2, Yamadaoka, Suita city, Osaka
06-6210-8293
nintei@dmi.med.osaka-u.ac.jp
YES
PA8170002
Ministry of Health, Labour and Welfare
2018 | Year | 06 | Month | 15 | Day |
Unpublished
Terminated
2018 | Year | 06 | Month | 05 | Day |
2018 | Year | 03 | Month | 09 | Day |
2019 | Year | 08 | Month | 11 | Day |
2022 | Year | 06 | Month | 30 | Day |
2018 | Year | 06 | Month | 14 | Day |
2020 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037108