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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517738-16-00 | EU Trial (CTIS) Number | ||
| 2022-002180-29 | EudraCT Number |
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| Name | Class |
|---|---|
| KCRI Sp. z o.o. | UNKNOWN |
| Medical University of Silesia | OTHER |
| Clinica Universidad de Navarra, Universidad de Navarra | OTHER |
| Hospital General Universitario Gregorio Marañon |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with VB-C01 | Experimental | Treatment arm in which patients will be treated with a VB-C01 cellularised patch. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB-C01 cellularised patch | Combination Product | surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high risk of developing heart failure |
| Measure | Description | Time Frame |
|---|---|---|
| combination of MACCEs at all follow up visits during the first year after treatment | combination of MACCEs at all follow up visits during the first year after treatment (after surgery, at 1, 3, 6, 9 and 12 months). MACCEs are defined as all cause death, myocardial infarction requiring target vessel revascularisation, hospitalisation for heart failure, cardiac tamponade or pericardial constriction, sustained ventricular tachycardia, ventricular fibrillation, and stroke. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Composite MACCE | Composite MACCE (all cause death, myocardial infarction requiring target vessel revascularisation, hospitalisation for heart failure, cardiac tamponade or pericardial constriction, sustained ventricular tachycardia, ventricular fibrillation, and stroke) at all follow up visits during the first year after treatment (after surgery, 1, 3, 6, 9 and 12 months), | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lluis Quintana, PhD, MBA | Contact | +49 6201 86-236 | quintana@bio.viscofan.com | |
| Jesus Izco, PhD | Contact | +34948198444 | IzcoJ@viscofan.com |
| Name | Affiliation | Role |
|---|---|---|
| Radoslaw Gocol, MD | Medical University of Silesia | Study Chair |
| Javier Bermejo, MD | Hospital General Universitario Gregorio Marañón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach | Katowice - Ochojec | 40-635 | Poland |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
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| OTHER |
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| Safety - Hematology parameters | Erythrocytes, Haemoglobin, Haematocrit, Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, Prothrombin time, APTT, INR. Measurement of the values and evaluation of their clinical significance in case they are outside of the normal range. | 12 months |
| Safety - Adverse Events | Any cause adverse event at all follow up visits during the first year after treatment (after surgery, 1, 3, 6, 9 and 12 months) | 12 months |
| Safety - Biochemical blood parameters | Measurement of biochemistry paramenters in blood including Glucose, Creatinine, Urea, GOT, GPT, GGT, Total bilirubin, Alkaline phosphatase, Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Total proteins, Sodium, Potassium, Calcium, Chloride. Evaluation of clinical significance in case values are out of normal range. | 12 months |
| Safety - New York Heart Association (NYHA) functional class | Assessment of the New York Heart Association (NYHA) functional class before surgery (the first assessment will be done during the screening process and repeated before the procedure), at 6 and 12 months after surgery. | 12 months |
| Safety - Minnesota Living with Heart Failure (MLHFQ) questionnaire | Minnesota Living with Heart Failure (MLHFQ) questionnaire, before surgery (the first assessment will be done during the screening process, at least one day before surgery), at 6 and 12 months after surgery. | 12 months |
| Safety - 6 minute walk test | The 6 minute walk test will be performed before surgery (the first assessment will be done during the screening process, at least one day before surgery), at 6 and 12 months after surgery. | 12 months |
| Safety - Brain natriuretic peptide curve (Nt proBNP or BNP) | Brain natriuretic peptide curve (Nt proBNP or BNP, depending on the availability at each site using the same parameter throughout the follow up of each patient). Levels will be measured during the screening process (the first assessment will be done, at least one day before surgery), on the second day after surgery and at 6 and 12 months after product administration. | 12 months |
| Safety - C reactive protein (CRP) levels | C reactive protein (CRP) levels will be assessed prior to surgery (the first assessment will be done during the screening process, repeated prior to surgery), at hospital discharge, and 1 month after product administration. | 1 month |
| Safety - Incidence of subacute pericardial inflammation or constrictive physiology | Incidence of subacute pericardial inflammation or constrictive physiology as assessed by echocardiography and cardiac magnetic resonance imaging (CMRI) at months 1, 6 and 12 after treatment. The first assessment will be done during the screening process. | 12 months |
| Safety - Immunological analysis | The following immunological analysis will be performed: B Lymphocytes, NK Lymphocytes (CD16+), T Lymphocytes (CD3+), Th Lymphocytes (CD4+), Activated Th Lymphocytes (CD4+DR+), Treg Lymphocytes (CD4+CD25+), Treg Lymphocytes (CD4+CD25+), Activated Treg Lymphocytes (CD4+CD25+DR+), Cytotoxic T Lymphocytes (CD8+), Activated Cytotoxic T Lymphocytes (CD8+DR+), Cytotoxic Treg Lymphocytes (CD8+CD25+), Activated Cytotoxic Treg Lymphocytes (CD8+CD25+DR+), Albumin, Alpha globulin, Beta globulin, Gamma globulin, IgG, IgM and anti-HLA antibodies (the first assessment will be done during the screening process) at discharge (at discharge excluding Serum Cytokines and anti-HLA antibodies) and 1 month after product administration. | 1 month |
| Efficacy - Change in scar size | Absolute change in scar size expressed as percentage of left ventricular mass (i.e. scar mass corrected for total left ventricular mass), absolute change in percentage of viable left ventricular mass (i.e. viable mass corrected for total left ventricular mass), absolute change in total scar size (expressed in grams), and absolute change in viable mass (expressed in grams). | 12 months |
| Efficacy - end systolic volume | Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis. | 12 months |
| Efficacy - end diastolic volume | Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis. | 12 months |
| Efficacy - ejection fraction | Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis. | 12 months |
| Efficacy - segmental contractility | Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis. | 12 months |
| Efficacy - segmental wall thickness | Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis. | 12 months |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |