Clinical Trial of Human (Allogeneic) iPS Cell-derived Cardiomyocytes Sheet for Ischemic Cardiomyopathy

General Information

Summary Targeting patients with severe ischemic cardiomyopathy, the purpose of this study is as follows: to confirm short-term efficacy by observing changes and transitions in cardiac function and clinical symptoms compared with each patient's baseline (before and after comparison) by human iPS cell-derived cardiomyocyte sheet transplantation, and to evaluate the safety and tolerability including the combined use of immunosuppressants.
Description The objective of this study is to confirm the efficacy and safety of a human (allogeneic) iPS cell-derived cardiomyocyte sheet in combination with an immunosuppressant for ischemic cardiomyopathy patients. The primary evaluation items will be improvement of left ventricular systolic function (LVEF) for efficacy, and safety will be assessed by blood tests, general laboratory tests, and other safety-related evaluations. Secondary evaluation items are NYHA functional evaluation, left ventricular remodeling evaluation by echocardiography, hemodynamic evaluation, physical activity function evaluation such as 6MWD and SAS, QOL, and exercise tolerance evaluation by questionnaires.
Clinical trials phase Phase 1
Start date (estimated) 2019-12-02
End date (estimated) 2023-05-30
Clinical feature
Label cardiomyopathy
Description A heart disease and a myopathy that is characterized by deterioration of the function of the heart muscle.; MESH:D009202 added from NeuroDevNet [WAK].

Administrative Information

NCT number NCT04696328
ICTRP weblink
Other study identifiers
Name CVSC0005
Source weblink
Public contact
Public email
First name Takuji
Last name Kawamura
Phone +81-6-6879-3154
City Osaka
Address freetext 2-15, Yamadaoka, Suita, Osaka 565-0871 Osaka Japan
Sponsors Osaka University Hospital


Which differentiated cell type is used
Label cardiac muscle cell
Description Cardiac muscle cells are striated muscle cells that are responsible for heart contraction. In mammals, the contractile fiber resembles those of skeletal muscle but are only one third as large in diameter, are richer in sarcoplasm, and contain centrally located instead of peripheral nuclei.; This class encompasses the muscle cells responsible for heart* contraction in both vertebrates and arthropods. The ultrastucture of a wide range of arthropod heart cells has been examined including spiders, horseshoe crabs, crustaceans (see Sherman, 1973 and refs therein) and insects (see Lehmacher et al (2012) and refs therein). According to these refs, the cells participating in heart contraction in all cases are transversely striated. Insects hearts additionally contain ostial cells, also transversely striated muscle cells, but which do not participate in heart contraction.


Recruitment Status Unknown Status
Comment recruitment status 10