Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure (ESCORT)

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) 2013-03-27
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).
Publications

Administrative Information

NCT Number NCT02057900
Other study identifiers
Name P100303
Source weblink http://clinicaltrials.gov/ct2/show/NCT02057900
Regulatory body approval
Name Comités de protection des personnes (CPP)
Country
France
Study sites
Public contact
Email contact.hegp@egp.aphp.fr
First name Philippe
Last name Menasché
Postcode 75015
City Paris
Country
France
Address freetext Hopital Europeen Georges Pompidou, Department of Cardiovascular Surgery Paris, France, 75015
Sponsors Assistance Publique - Hôpitaux de Paris

Cell Line

Stem cell lines obtained from

Recruitment

Recruitment Status Completed
Estimated number of participants 6
Contact institutions/departments