Ischemic Heart Disease Clinical Trial
— ESCORTOfficial title:
Transplantation of Human Embryonic Stem Cell-derived CD15+ Isl-1+ Progenitors in Severe Heart Failure
NCT number | NCT02057900 |
Other study ID # | P100303 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 27, 2013 |
Est. completion date | March 22, 2018 |
Verified date | July 2018 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 22, 2018 |
Est. primary completion date | March 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 81 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Department of Cardiovascular Surgery | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Puymirat E, Geha R, Tomescot A, Bellamy V, Larghero J, Trinquart L, Bruneval P, Desnos M, Hagège A, Pucéat M, Menasché P. Can mesenchymal stem cells induce tolerance to cotransplanted human embryonic stem cells? Mol Ther. 2009 Jan;17(1):176-82. doi: 10.10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number and nature of adverse events | Evidence for new clinical/biological abnormalities, occurrence of arrhythmias or development of a cardiac or extra-cardiac tumor. | Within the first year after surgery | |
Secondary | Feasibility of patch's generation and its efficacy on cardiac functions | 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. | Within the first year after surgery |
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