General Information |
| Summary |
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are:
- Is this product safe to deliver to humans
- Is the conduct of this trial feasible
Participants will be asked to:
- Agree to testing and monitoring before and after product administration
- Receive investigational product
- Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2023-02-03 |
| End date (estimated) |
2029-02-28 |
| Clinical feature |
| Label |
congenital heart disease |
| Link |
http://purl.obolibrary.org/obo/DOID_1682 |
| Description |
OMIM mapping confirmed by DO. [SN]. |
|
Administrative Information |
| NCT number |
NCT05647213 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05647213 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT05647213https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05647213 |
| Study sites |
|
| Public contact |
| Email |
clint@webuildhearts.org |
| Public email |
clint@webuildhearts.org |
| First name |
Clint |
| Last name |
Hagen |
| Phone |
+1 507 577-1764 |
| Country |
|
|
| Sponsors |
HeartWorks, Inc.
|
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 |
| Comment recruitment status |
50 |
| Contact institutions/departments |
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