General Information |
| Summary |
The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure. |
| Description |
This is a single center, open-label, three-group dose-escalation (phase I) study followed by dose-extension (phase IIa) study in up to 36 severe ischemic heart failure patients. It is estimated that up to 18 phase I patients will be received HiCM-188 intramyocardial injection during CABG surgery. The maximum number of subjects after dose escalation and dose extension studies in each dose group is 12. All the subjects need take immunosuppressant after transplantation. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2023-09-05 |
| End date (estimated) |
2025-03-05 |
| 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). |
|
Administrative Information |
| NCT number |
NCT06340048 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06340048 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06340048 |
| Public contact |
| Email |
liuxc@tedaich.com |
| Public email |
liuxc@tedaich.com |
| First name |
Xiaocheng |
| Last name |
Liu |
| Phone |
+86-022-65208030 |
| Country |
|
|
| Sponsors |
Help Therapeutics
|
| 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 |
Recruiting |
| Estimated number of participants |
36 |
