[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570267":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":50,"responsibleParty":68,"collaborators":72,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":26,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"ISAR Klinikum","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"UA-ADRCs group","EXPERIMENTAL","Patients in the UA-ADRC (uncultured, autologous, adipose-derived regenerative cells) group will be treated as follows:\n\n1. Patients will have an outpatient liposuction procedure from the abdomen, bilateral flanks, and\u002For medial thigh (at least 100 mL of adipose tissue) to get cell product.\n2. Oral sedation and local anesthesia with tumescent solution will be used. Patients' vitals will be monitored and recorded during the procedure and in 1 to 2 hours post-procedure.\n3. Each patient in the UA-ADRC group will have cells isolated using the Transpose RT\u002FMatrase system (InGeneron).\n4. Cell product testing will be assessed with the following acceptance criteria: total nucleated cell count is \\> 35 million cells, b) cell viability is \\> 75%. AE status will be monitored for 30 days post-liposuction procedure.\n5. The i.cv injection of UA-ADRCs will be given using an aseptic technique. This group will include 24 patients.",[13],"Biological: Uncultured, autologous, adipose-derived regenerative cells (UA-ADRCs)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Patients will receive continuation of their best guideline based medical treatment. This group will include 12 patients.",[19],"Other: Continuation of patient's best guideline based medical treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Uncultured, autologous, adipose-derived regenerative cells (UA-ADRCs)","Intracardial venous injection of fresh, uncultured, autologous, adipose-derived regenerative cells isolated from lipoaspirate at the point of care.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Continuation of patient's best guideline based medical treatment","Patients will receive continuation of their best guideline based medical treatment.",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Abay Baigenzhin, Prof Dr","National Scientific Medical Center","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":39},"Ralf Rothoerl, Dr","International Foundation of Medicine and Science","STUDY_DIRECTOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Anastassiya Ganina-Smelova, PhD","CONTACT","+77024346421","anastassiya_smelova@mail.ru",{"name":47,"role":43,"phone":48,"phoneExt":26,"email":49},"Aizhan Akhaeva, PhD","+77075008522","akhaeva@mail.ru",[51],{"facility":34,"status":52,"city":53,"state":26,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Astana","010009","Kazakhstan","KZ",{"type":58,"coordinates":59},"Point",[60,61],71.44598,51.1801,{"lat":61,"lon":60},[64,65,66],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},{"name":47,"role":43,"phone":48,"phoneExt":26,"email":49},{"name":67,"role":43,"phone":26,"phoneExt":26,"email":26},"Ralf Roethoerl, Dr",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Ralf Rothoerl","coordinator",[73,76,79],{"name":74,"class":75},"National Scientific Medical Center, Kazakhstan","OTHER_GOV",{"name":77,"class":78},"Internationnal Foundation Medicine and Science","UNKNOWN",{"name":80,"class":6},"Alliance of Cardiovascular Researchers","100570267","phase-2-study-to-assess-safety-and-efficacy-of-treating-symptomatic-ischemic-chronic-congestive-heart-failure-patients-with-an-lvef-of-40-with-fresh-uncultured-autologous-adipose-derived-regenerative-cells-isolated-from-lipoaspirate-100570267",false,"NCT06705023","Study to Assess Safety and Efficacy of Treating Symptomatic, Ischemic, Chronic Congestive Heart Failure Patients with an LVEF of ≤40% with Fresh, Uncultured, Autologous, Adipose-derived Regenerative Cells Isolated from Lipoaspirate.","Adipose-derived Regenerative Cells Treatment for Congestive Heart Failure","Inclusion Criteria\n\n* Have documented coronary artery disease with evidence of myocardial injury, LV dysfunction, and clinical evidence of heart failure\n* Have an EF ≤40% by cardiac MRI\n* Be receiving guideline-driven medical therapy for heart failure at stable and tolerated doses for ≥1 month before consent\n* Be a candidate for right heart cardiac catheterization\n* Have New York Heart Association class I, II, or III heart failure symptoms\n* If a female of childbearing potential, be willing to use one form of birth control for the duration of the study, and undergo a pregnancy test at baseline and within 36 h before treatment\n\nExclusion Criteria\n\n* Indication for standard-of-care surgery (including valve surgery, placement of LV assist device, or imminent heart transplantation), CABG procedure, and PCI. Candidates cannot be UNOS 1A or 1B, and they must have documented low probability of being transplanted.\n* PCI within 3 months of randomization\n* CABG within 3 months of randomization\n* Valvular heart disease including mechanical or bioprosthetic heart valve, severe valvular (any valve) insufficiency\u002Fregurgitation within 12 month of consent, and aortic stenosis with valve area ≤1.5 cm2\n* History of ischemic or hemorrhagic stroke within 90 d of consent\n* History of an LV remodeling surgical procedure utilizing prosthetic material\n* Presence of a pacemaker and ICD generator with any of the following limitations\u002Fconditions: manufactured before the year 2015\n* Leads implanted \\\u003C6 week before consent\n* Non-transvenous epicardial or abandoned leads\n* Subcutaneous ICDs\n* Leadless pacemakers\n* Pacemaker-dependence with an ICD (pacemaker-dependent candidates without an ICD are not excluded)\n* Any other condition that, in the judgment of device-trained staff, would deem an MRI contraindicated\n* A CRT device implanted within 3 months of consent\n* An appropriate ICD firing or antitachycardia pacing for ventricular fibrillation or ventricular tachycardia within 30 days of consent\n* Ventricular tachycardia (≥20 consecutive beats) without an ICD within 3 month of consent, or symptomatic Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent\n* Presence of LV thrombus\n* Baseline eGFR \\\u003C35 mL\u002Fmin per 1.73 m2\n* Poorly controlled blood glucose levels (HbA1c \\>10%)\n* Hematologic abnormality evidenced by hematocrit \\\u003C25%, white blood cell \\\u003C2500 per μL, or platelet count \\\u003C100 000 per μL\n* Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3× the ULN\n* Coagulopathy (INR ≥1.3) not due to a reversible cause (eg, warfarin and factor Xa inhibitors). Patients who cannot be withdrawn from anticoagulation will be excluded.\n* HIV or active HBV or HCV\n* Allergy to radiographic contrast material that cannot adequately be managed by premedication\n* Known history of anaphylactic reaction to penicillin or streptomycin\n* Received gene or cell-based therapy from any source within the previous 12 months\n* History of malignancy within 3 years, excluding basal cell carcinoma or cervical carcinoma in situ which have been definitively treated\n* Condition that limits expected lifespan to \\\u003C1 year\n* History of drug or alcohol abuse\n* Chronic immunosuppressant therapy such as corticosteroids or TNF-α antagonists\n* Cognitive or language barriers that prohibit obtaining informed consent or any study elements\n* Pregnancy or lactation or plans to become pregnant in the next 12 months\n* Conditions that, in the judgment of the Investigator or Sponsor, would impair enrollment, cell harvest, administration or follow-up\n\nALT indicates alanine aminotransferase; AST, aspartate aminotransferase; CABG, coronary artery bypass grafting; CRT, cardiac resynchronization therapy; EF, ejection fraction; eGFR, estimated glomerular filtration rate; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; ICD, implantable cardioverter defibrillator; INR, international normalized ratio; LV, left ventricular; MRI, magnetic resonance imaging; PCI, percutaneous coronary intervention; TNF-α, tumor necrosis factor-α; ULN, upper limit of normal; UNOS, United Network for Organ Sharing; and Vo2 max, maximal oxygen consumption.","ALL","21 Years","80 Years",{"count":92,"type":93},36,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","To investigate patients suffering from iHF and a LVEF of equal or less than 40% despite best medical treatment safety and efficacy of a single retrograde intra-cardiac venous (i.cv.) injection of UA-ADRCs isolated from lipoaspirate at the point of care, using the Transpose® RT \u002F Matrase System (InGeneron, Houston, TX, USA) through an over-the- wire, small balloon catheter, advanced through the coronary si-nus and located within a coronary vein at the site of inter-est, versus patients on best medical treatment.",[99,100,101,102],"Myocardial Injury","LV Dysfunction","Coronary Artery Disease","Heart Failure",[104,105,106,107,108,109,110,111,112],"congestive heart failure","adipose-derived regenerative cells","left ventricular ejection fraction","lipoaspirate","retrograde intra-cardiac venous injection","Cardiac Magnetic Resonance Imaging","Cardiac Computer Tomography","end systolic volume","end diastolic volume","2024-11-28",{"date":115,"type":116},"2024-12-03","ACTUAL",{"date":118,"type":116},"2024-11-18",{"date":120,"type":93},"2025-12-31",{"name":70,"class":6},1]