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Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure (ESCORT)
This study is currently recruiting participants.
Verified August 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02057900
First received: September 17, 2013
Last updated: September 1, 2016
Last verified: August 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Ischemic Heart Disease | Biological: Human embryonic stem cell-derived CD15+ Isl-1+ progenitors | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Transplantation of Human Embryonic Stem Cell-derived CD15+ Isl-1+ Progenitors in Severe Heart Failure |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 6 |
| Study Start Date: | June 2013 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 81 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02057900
Please refer to this study by its ClinicalTrials.gov identifier: NCT02057900
Contacts
| Contact: Philippe Menasché, MD, PhD | 33 1 56 09 20 00 ext 36 22 | philippe.menasche@egp.aphp.fr | |
| Contact: Albert A Hagège, MD, PhD | 33 1 56 09 20 00 ext 37 13 | albert.hagege@egp.aphp.fr |
Locations
| France | |
| Department of Cardiovascular Surgery | Recruiting |
| Paris, France, 75015 | |
| Contact: Philippe Menasché, MD, PhD 33 1 56 09 20 00 ext 36 22 | |
| Contact: Albert A Hagège, MD, PhD 33 1 56 09 20 00 ext 37 13 albert.hagege@egp.aphp.fr | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Philippe Menasché, MD, PhD | Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Paris, France |
More Information
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT02057900 History of Changes |
| Other Study ID Numbers: |
P100303 |
| Study First Received: | September 17, 2013 |
| Last Updated: | September 1, 2016 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Postinfarction heart failure Transplantation of human embryonic stem cell-derived cardiac progenitors Tissue-engineered cellular graft Fibrin hydrogel |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Myocardial Ischemia Coronary Artery Disease Cardiovascular Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on June 23, 2017