General Information |
| Summary |
This clinical study will utilize a new cell therapy approach (Human embryonic stem cells derived cardiomyocytes or hESC-CMs) to improve survival and cardiac function in patients with chronic left ventricular dysfunction secondary to MI (Myocardial Infarction). |
| Description |
The phase I dose-escalation pilot study is intended as an initial safety assessment to establish the MTD prior to the phase II randomized, double-blinded, placebo-controlled study. An estimated eighteen (18) patients in phase I who are scheduled to undergo cardiac catheterization and have met all inclusion/exclusion criteria will be enrolled. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2022-03-22 |
| End date (estimated) |
2025-10-31 |
| Clinical feature |
| Label |
heart failure |
| Link |
http://purl.obolibrary.org/obo/SYMP_0000292 |
|
Administrative Information |
| NCT number |
NCT05068674 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05068674 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/study/NCT05068674 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
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|
| Public contact |
| Email |
joewu@stanford.edu |
| First name |
Joseph |
| Last name |
Wu |
| Phone |
(650) 736-2246 |
| Fax |
(650) 736-0234 |
| Street |
265 Campus Drive, G1120B |
| Postcode |
94305 |
| City |
STANFORD |
| Country |
|
|
| Sponsors |
Joseph C. Wu
|
| 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 |
18 |
