Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure (ESCORT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02057900 |
Recruitment Status :
Completed
First Posted : February 7, 2014
Last Update Posted : July 10, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 81 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 and less than 81 years
- Severe left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) ≤ 35% as assessed by echocardiography or scintigraphy
- History of myocardial infarction (older than 6 months) with a residual akinesia involving more than 2 (out of 16) contiguous segments, as assessed by basal echocardiography
- New York Heart Association (NYHA) Class III or IV despite optimal standard of care including diuretics and angiotensin receptor blockers and, if possible, beta blockers and aldosterone blockers
- Previous implantation of an automatic internal defibrillator associated, whenever indicated, to ventricular resynchronization
- Indication for a conventional cardiac surgical procedure : coronary artery bypass grafting involving, or not, the infarct area planned to be covered by the cell-loaded patch or mitral valve repair or replacement for ischemic mitral valve regurgitation; Non Eligibility to heart transplantation; Affiliation to a social security regimen
- Willingness and ability to give written informed consent
Exclusion Criteria:
- Pregnant or potentially child-bearing women
- Patients with poor echogenicity
- Left ventricular aneurysm
- Contra-indication to immunosuppressive drugs (history of cancer, infections like B or C hepatitis, positivity for Hepatitis-B, HIV, HTLV1)
- Contra-indication to sternotomy
- Alloimmunisation against the cell line from which the progenitors are derived
- Cardiogenic shock or NYHA Class IV heart failure requiring need for intravenous drugs
- Intellectual deterioration or psychiatric disease interfering with the ability to obtain an informed consent and to achieve a close follow-up of the patient
- Noncardiac disease which may reduce life expectancy in the short term
- Simultaneous participation to another trial

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
France | |
Department of Cardiovascular Surgery | |
Paris, France, 75015 |
Principal Investigator: | Philippe Menasché, MD, PhD | Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Paris, France |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT02057900 |
Other Study ID Numbers: |
P100303 |
First Posted: | February 7, 2014 Key Record Dates |
Last Update Posted: | July 10, 2018 |
Last Verified: | July 2018 |
Postinfarction heart failure Transplantation of human embryonic stem cell-derived cardiac progenitors Tissue-engineered cellular graft Fibrin hydrogel |
Heart Failure Heart Diseases Myocardial Ischemia Coronary Artery Disease Cardiovascular Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |