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| Name | Class |
|---|---|
| Ministerio de Ciencia e Innovación, Spain | OTHER_GOV |
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It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that remain symptomatic despite optimal medical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VB-C01 | Experimental | Surgical technique: Via left lateral thoracotomy, the heart is lifted and supported on two deep pericardial points with 4-0 or 5-0 Prolene double arrmed suture. Each suture is passed through the reinforced frame of the collagen membrane containing the stem cells (VB-C01) and then tied, while the upper part of the patch is held with forceps. After securing the lower part of the pericardial layer, the heart is allowed to slowly recover its position with the pericardial cavity while the collagen membrane is mobilized to cover all of the target area. If necessary, some sutures can be used to fix the patch VB-C01 to the epicardial surface of the heart. Each suture is likewise passed through the reinforced frame of the membrane. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB-C01 | Device | Surgical implant of VB-C01 (Collagen membrane seeded with allogeneic stem cells isolated from adipose tissue, ADSC). |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite safety endpoint formed by the major adverse cardiac and cerebrovascular events (MACCE) occurring on all visits during the first year after implantation. | MACCE include: all-cause death, cardiovascular death, re-infarction, need for revascularization, hospitalization for heart failure, sustained ventricular tachycardia, ventricular fibrillation, or stroke. | During the first year after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all-cause death | During the first year after implantation | |
| Incidence of cardiovascular death | During the first year after implantation | |
| Incidence of re-infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Casado Plasencia | Contact | +34 683 375 694 | casadoa@viscofan.com | |
| Blanca Jáuregui | Contact | +34 620 853 544 | JaureguiB@viscofan.com |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Jesús Fernández-Avilés Díaz | Hospital General Universitario Gregorio Marañón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Universidad de Navarra | Not yet recruiting | Pamplona | Navarre | 31008 | Spain |
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| During the first year after implantation |
| Incidence of need for revascularization | During the first year after implantation |
| Incidence of hospitalization for heart failure | During the first year after implantation |
| Incidence of sustained ventricular tachycardia | During the first year after implantation |
| Incidence of ventricular fibrillation | During the first year after implantation |
| Incidence of stroke | During the first year after implantation |
| Incidence of surgical complications | During the first year after implantation |
| Changes in the pericardial physiology | Assessed by echocardiography or MRI | During the first year after implantation |
| VT inducibility | Heterogeneous tissue on MRI as well as the presence of late potentials on the electrophysiological study scheduled at 1 year of follow-up. | During the first year after implantation |
| Changes in DSA-HLA | During the first year after implantation |
| Changes in proinflammatory cytokines | During the first year after implantation |
| Changes in immunological cell types. | During the first year after implantation |
| Changes in end-systolic volume | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in end-diastolic volume | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in left ventricular ejection fraction | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in sphericity index | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in segmental contraction score (normal / hypokinetic / akinetic / dyskinetic) in the 17 myocardial segments | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in systolic thickening by myocardial segments | Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in the scar size expressed in grams | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in the viable myocardial mass expressed in grams | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in the scar size expressed in percentage of LV | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in the percentage of viable myocardium in LV | Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up. | During the first year after implantation |
| Changes in the functional class | According to the New York Heart Association (NYHA) for dyspnea | During the first year after implantation |
| Changes in the patient-perceived quality of life | According to the Minnesota Living with Heart Failure Questionnaire (MLHFQ) | During the first year after implantation |
| Changes in the distance covered on the 6-minute walk test | During the first year after implantation |
| Changes in the peak oxygen consumption on ergospirometry | During the first year after implantation |
| Changes in the brain natriuretic peptide | During the first year after implantation |
| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | 28007 | Spain |
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