General Information |
| Summary |
Heart failure has a high morbidity and mortality because the heart is one of the least regenerative organs in the human body. Drug treatments for heart failure manage symptoms but do not restore lost myocytes. Cellular replacement therapy is a potential approach to repair damaged myocardial tissue, restore cardiac function, which has become a new strategy for the treatment of heart failure. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of cardiomyocytes at the time of coronary artery bypass grafting in patients with chronic heart failure. |
| Description |
Patients with heart failure will be treated with allogenic human pluripotent stem cell-derived cardiomyocytes ( hPSC-CM ) from healthy donors. The cells will be injected directly into the myocardium at time of coronary artery bypass grafting. Patients will be assessed at 1, 3, 6 and 12 months after cell transplantation for safety, feasibility and efficacy. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2021-10-08 |
| End date (estimated) |
2024-10-30 |
| Clinical feature |
| Label |
Ischemic Heart Disease |
| Link |
http://purl.obolibrary.org/obo/NCIT_C50625 |
| Description |
A disorder of cardiac function caused by insufficient blood flow to the muscle tissue of the heart. The decreased blood flow may be due to narrowing of the coronary arteries, to obstruction by a thrombus, or less commonly, to diffuse narrowing of arterioles and other small vessels within the heart. Severe interruption of the blood supply to the myocardial tissue may result in necrosis of cardiac muscle (myocardial infarction). |
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| Publications |
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Administrative Information |
| NCT number |
NCT03763136 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03763136 |
| Other study identifiers |
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| Source weblink |
https://clinicaltrials.gov/ct2/show/study/NCT03763136 |
| Public contact |
| Email |
wangjx@helpsci.com.cn |
| First name |
Jiaxian |
| Last name |
Wang |
| Phone |
+8618565616060 |
| City |
Nanjing |
| Country |
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| Sponsors |
Help Therapeutics
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| Collaborators |
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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. |
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Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
15 |
| Contact institutions/departments |
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