General Information |
| Summary |
Heart failure is the primary cause of morbidity and mortality worldwide. Currently drug treatments for heart failure manage the symptoms, but not restore the loss cardiomyocytes due to the very limited regenerative capability in the adult heart. Novel reparative therapies that replace the cardiomyocytes loss are highly demanded to restore the cardiac function. The main purposes of this explanatory study is to investigate the safety and efficacy of the catheter-based endocardial delivery of human iPSC-derived cardiomyocytes in patients with congestive heart failure. |
| Description |
Patients with severe congestive heart failure will be treated with allogeneic human iPSC-derived cardiomyocytes (HiCM-188) through the catheter-based injections. HiCM188, produced by Help therapeutics with cGMP condition, will be transplanted into the myocardium through a transcatheter endocardial injection system with two dosage (100 million cells or 400 million cells). The safety and efficacy assessments will be conducted at1, 3, 6 and 12 months after the cell transplantation. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2021-09-21 |
| End date (estimated) |
2023-07-31 |
| Clinical feature |
| Label |
congestive heart failure |
| Link |
http://purl.obolibrary.org/obo/DOID_6000 |
| Description |
A heart disease that is characterized by any structural or functional cardiac disorder that impairs the ability of the heart to fill with or pump a sufficient amount of blood throughout the body. |
|
Administrative Information |
| NCT number |
NCT04982081 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04982081 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT04982081 |
| Public contact |
| Email |
wangjx@helpsci.com.cn |
| First name |
Jiaxian |
| Last name |
Wang |
| Phone |
+8618565616060 |
| City |
Nanjing |
| 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 |
20 |
