Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure (ESCORT)
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|ClinicalTrials.gov Identifier: NCT02057900|
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : July 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease||Biological: Human embryonic stem cell-derived CD15+ Isl-1+ progenitors||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transplantation of Human Embryonic Stem Cell-derived CD15+ Isl-1+ Progenitors in Severe Heart Failure|
|Actual Study Start Date :||May 27, 2013|
|Actual Primary Completion Date :||March 22, 2018|
|Actual Study Completion Date :||March 22, 2018|
Experimental: Human embryonic stem cell
Patients with ischemic heart failure receiving a fibrin gel embedding human embryonic stem cell-derived CD15+ Isl-1+ progenitors in addition to coronary artery bypass grafting and/or a mitral valve procedure.
Biological: Human embryonic stem cell-derived CD15+ Isl-1+ progenitors
Epicardial delivery of a fibrin patch embedding human embryonic stem cell-derived CD15+ Isl-1+ progenitors
- number and nature of adverse events [ Time Frame: Within the first year after surgery ]Evidence for new clinical/biological abnormalities, occurrence of arrhythmias or development of a cardiac or extra-cardiac tumor.
- Feasibility of patch's generation and its efficacy on cardiac functions [ Time Frame: Within the first year after surgery ]Feasibility will be assessed by the ability to generate hESC-derived CD15+ Isl-1+ progenitors according to preset quality measures, to incorporate these cells in a fibrin patch, to deliver this patch onto the epicardium of the infarct area and to cover it with an autologous pericardial flap. Efficacy will be assessed on the following end points : 1- left ventricular function; 2- viability of the grafted area; 3- functional status; 4- major adverse cardiovascular events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057900
|Department of Cardiovascular Surgery|
|Paris, France, 75015|
|Principal Investigator:||Philippe Menasché, MD, PhD||Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Paris, France|