General Information |
| Summary |
The purpose of the study is to assess the feasibility and safety of a transplantation of cardiac-committed progenitor cells derived from human embryonic stem cells in patients with severe heart failure. |
| Description |
Heart failure due to coronary artery disease is a major problem because of its high prevalence, increased incidence and associated costs. When conventional medical/interventional treatments fail and if cardiac transplantation is contra-indicated, alternate options need to be considered. Transplantation of stem cells has emerged as one of them. While the optimal cell type still remains debatable, there is compelling evidence that cells whose phenotype closely matches that of the recipient tissue look sound candidates. In this context, human embryonic stem cells are attractive because of the possibility to drive their fate in vitro, prior to transplantation, towards a cardiac phenotype. We have developed a process for achieving such a commitment and generating cardiac-directed cells. The objective of this study is to assess both the feasibility and safety of this approach. In addition, the disadvantages of multiple intramyocardial injections have now been recognized. We have then taken advantage of the surgical setting of the trial (which entails concomitant coronary artery bypass or a mitral valve procedure) to switch from injections to the epicardial delivery of a fibrin gel into which the progenitor cells have been embedded. Coverage of this cell-loaded patch by an autologous pericardial flap is finally designed to provide trophic factors to the underlying cellular graft with the hope of improving its viability. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2013-05-27 |
| End date (estimated) |
2018-03-22 |
| 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 |
NCT02057900 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02057900 |
| Other study identifiers |
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| Source weblink |
http://clinicaltrials.gov/ct2/show/NCT02057900 |
| Regulatory body approval |
| Name |
Comités de protection des personnes (CPP) |
| Country |
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| Study sites |
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| Public contact |
| Email |
contact.hegp@egp.aphp.fr |
| First name |
Philippe |
| Last name |
Menasché |
| Postcode |
75015 |
| City |
Paris |
| Country |
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| Address freetext |
Hopital Europeen Georges Pompidou, Department of Cardiovascular Surgery Paris, France, 75015 |
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| Sponsors |
Assistance Publique - Hôpitaux de Paris
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Cells |
| Source pluripotent stem cell lines |
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| Which differentiated cell type is used |
| Label |
cardioblast |
| Link |
http://purl.obolibrary.org/obo/CL_0002664 |
| Description |
A stem cell that can give rise to multiple cell types (i.e. smooth muscle, endothelial) in the developing heart.; Discrepancy in develops from origins prevents me from making the assertion that cardioblasts give rise to all instances of cardiocytes as we state cardiac muscle cells develop from cardiac myoblast, which in turn develop from muscle stem cell. |
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Recruitment |
| Recruitment Status |
Completed |
| Estimated number of participants |
10 |
| Contact institutions/departments |
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