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 |
| Link |
http://purl.obolibrary.org/obo/DOID_0050700 |
| 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 |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04696328 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/study/NCT04696328 |
| Public contact |
| Email |
saisentan@tissue.med.osaka-u.ac.jp |
| Public email |
saisentan@tissue.med.osaka-u.ac.jp |
| First name |
Takuji |
| Last name |
Kawamura |
| Phone |
+81-6-6879-3154 |
| City |
Osaka |
| Country |
|
| Address freetext |
2-15, Yamadaoka, Suita, Osaka 565-0871 Osaka Japan |
|
| Sponsors |
Osaka University Hospital
|
| Collaborators |
|
Cells |
| Which differentiated cell type is used |
| Label |
cardiac muscle cell |
| Link |
http://purl.obolibrary.org/obo/CL_0000746 |
| 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 |
| Recruitment Status |
Unknown Status |
| Comment recruitment status |
10 |
