[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589622":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":30,"locations":40,"responsibleParty":57,"collaborators":59,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":20,"enrollmentInfo":79,"targetDuration":20,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":95,"whyStopped":20,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Viscofan","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with VB-C01","EXPERIMENTAL","Treatment arm in which patients will be treated with a VB-C01 cellularised patch.",[13],"Combination Product: VB-C01 cellularised patch",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","VB-C01 cellularised patch","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",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Radoslaw Gocol, MD","Medical University of Silesia","STUDY_CHAIR",{"name":27,"affiliation":28,"role":29},"Javier Bermejo, MD","Hospital General Universitario Gregorio Marañón","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":20,"email":35},"Lluis Quintana, PhD, MBA","CONTACT","+49 6201 86-236","quintana@bio.viscofan.com",{"name":37,"role":33,"phone":38,"phoneExt":20,"email":39},"Jesus Izco, PhD","+34948198444","IzcoJ@viscofan.com",[41],{"facility":42,"status":20,"city":43,"state":20,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":20,"geoPoint":20,"contacts":47},"Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach","Katowice - Ochojec","40-635","Poland","PL",[48,51,53,54],{"name":23,"role":33,"phone":49,"phoneExt":20,"email":50},"+48 32 3598877","kkch@sum.edu.pl",{"name":52,"role":33,"phone":49,"phoneExt":20,"email":50},"Kowalowka Adam, MD",{"name":23,"role":29,"phone":20,"phoneExt":20,"email":20},{"name":55,"role":56,"phone":20,"phoneExt":20,"email":20},"Adam Kowalowka, MD","SUB_INVESTIGATOR",{"type":58,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[60,63,65,67],{"name":61,"class":62},"KCRI Sp. z o.o.","UNKNOWN",{"name":24,"class":64},"OTHER",{"name":66,"class":64},"Clinica Universidad de Navarra, Universidad de Navarra",{"name":68,"class":64},"Hospital General Universitario Gregorio Marañon","100589622","phase-1-safety-and-efficacy-of-epicardial-implantation-of-collagen-membranes-with-allogeneic-adipose-derived-stem-cells-100589622",false,"NCT06956807","Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells","First in Human Open Label Multicentre Clinical Trial to Evaluate the Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells in Patients With Ischaemic Left Ventricular Dysfunction Scheduled to Undergo Coronary Revascularisation Surgery","CARDIOMESH II","Inclusion Criteria:\n\n1. Patients planning to undergo coronary revascularisation surgery within one month of study entry.\n2. LVEF ≤45% by CMRI.\n3. History of myocardial infarction at least 3 months prior to inclusion.\n4. Scar covering at least 15% of the total left ventricular myocardial mass defined by late enhancement on CMRI.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial within 30 days prior to inclusion.\n2. Prior treatment with cell or gene therapy.\n3. Be a candidate for heart transplant at the time of study entry.\n4. Diagnosis of acute myocardial infarction with 3 months prior to inclusion.\n5. Need for urgent revascularisation surgery.\n6. Strict contraindication for the use of CMRI (pacemaker or implantable automatic defibrillator carriers, previous reactions to gadolinium contrast, claustrophobia, cochlear implants, etc.).\n7. Presence of uncontrolled ventricular arrhythmias (ventricular tachycardia or ventricular fibrillation) at the time of implant surgery.\n8. Active systemic infection.\n9. Women who are pregnant or breastfeeding.\n10. Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his\u002Fher consent\n11. Advanced dementia according to the Barthel index.\n12. History of primary or acquired immunodeficiency or on immunosuppressive therapy (within 3 months prior to inclusion or if the need for immunotherapy is foreseeable at any time during the study follow up).\n13. Tumour disease, except that eradicated at least 5 years prior to inclusion in the study and without receiving chest radiotherapy. Completely eradicated non melanoma skin tumours (at any time) not requiring chest chemotherapy or radiotherapy are permitted.\n14. History of autoimmune disease.\n15. Stroke within 12 months prior to inclusion.\n16. Respiratory compromise or need for home oxygen therapy.\n17. Life expectancy of less than 1 year for any reason","ALL","18 Years",{"count":80,"type":81},10,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","* The Cardiomesh II clinical trial is a phase I open label study intended to enrol 10 patients to evaluate the safety and efficacy of 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.\n* The primary objective of the study is to evaluate the safety of surgical implantation of this membrane in patients with large ischaemic myocardial scars scheduled to undergo coronary revascularisation surgery. The secondary objective is to investigate the efficacy of the above treatment in terms of reduction of scar size and ventricular function parameters.",[87,88,89],"CABG-patients","Heart Failure","Myocardial Infarction (MI)",[91,92,93,94],"heart failure","coronary revascularisation surgery","adipose-derived stem cells","myocardial infarction","NOT_YET_RECRUITING","2025-04-24",{"date":98,"type":99},"2025-05-04","ACTUAL",{"date":101,"type":81},"2025-09-01",{"date":103,"type":81},"2027-06-30",{"name":5,"class":6},1]