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.

Launched by RALF ROTHOERL · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with chronic heart failure who have a weakened heart function (known as a low ejection fraction of 40% or less). The study aims to see if injecting a special type of regenerative cells, taken from the patient’s own fat, can improve heart function and overall health. Participants will receive either the cell treatment or continue with their existing medical care, and the trial is currently looking for volunteers who meet specific health criteria.

To be eligible for this trial, participants need to have a known heart condition that has caused heart injury and symptoms of heart failure. They must also be stable on heart medications for at least a month before joining the study. If you or someone you know is struggling with severe heart issues and meets these criteria, this trial could offer an opportunity to explore a potentially new treatment option. Participants can expect close monitoring throughout the study to ensure their safety and track the treatment's effects on their heart health.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Have documented coronary artery disease with evidence of myocardial injury, LV dysfunction, and clinical evidence of heart failure
• • Have an EF ≤40% by cardiac MRI
• • Be receiving guideline-driven medical therapy for heart failure at stable and tolerated doses for ≥1 month before consent
• • Be a candidate for right heart cardiac catheterization
• • Have New York Heart Association class I, II, or III heart failure symptoms
• • 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
• • Exclusion Criteria
• • 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.
• • PCI within 3 months of randomization
• • CABG within 3 months of randomization
• • Valvular heart disease including mechanical or bioprosthetic heart valve, severe valvular (any valve) insufficiency/regurgitation within 12 month of consent, and aortic stenosis with valve area ≤1.5 cm2
• • History of ischemic or hemorrhagic stroke within 90 d of consent
• • History of an LV remodeling surgical procedure utilizing prosthetic material
• • Presence of a pacemaker and ICD generator with any of the following limitations/conditions: manufactured before the year 2015
• • Leads implanted \<6 week before consent
• • Non-transvenous epicardial or abandoned leads
• • Subcutaneous ICDs
• • Leadless pacemakers
• • Pacemaker-dependence with an ICD (pacemaker-dependent candidates without an ICD are not excluded)
• • Any other condition that, in the judgment of device-trained staff, would deem an MRI contraindicated
• • A CRT device implanted within 3 months of consent
• • An appropriate ICD firing or antitachycardia pacing for ventricular fibrillation or ventricular tachycardia within 30 days of consent
• • 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
• • Presence of LV thrombus
• • Baseline eGFR \<35 mL/min per 1.73 m2
• • Poorly controlled blood glucose levels (HbA1c \>10%)
• • Hematologic abnormality evidenced by hematocrit \<25%, white blood cell \<2500 per μL, or platelet count \<100 000 per μL
• • Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3× the ULN
• • 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.
• • HIV or active HBV or HCV
• • Allergy to radiographic contrast material that cannot adequately be managed by premedication
• • Known history of anaphylactic reaction to penicillin or streptomycin
• • Received gene or cell-based therapy from any source within the previous 12 months
• • History of malignancy within 3 years, excluding basal cell carcinoma or cervical carcinoma in situ which have been definitively treated
• • Condition that limits expected lifespan to \<1 year
• • History of drug or alcohol abuse
• • Chronic immunosuppressant therapy such as corticosteroids or TNF-α antagonists
• • Cognitive or language barriers that prohibit obtaining informed consent or any study elements
• • Pregnancy or lactation or plans to become pregnant in the next 12 months
• • Conditions that, in the judgment of the Investigator or Sponsor, would impair enrollment, cell harvest, administration or follow-up
• • ALT 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.