Treatment for heart failure using patients' own fat-derived cells
Adipose-derived Regenerative Cells Treatment for Congestive Heart Failure
This study is testing whether injecting patients' own fat cells can improve heart function in people with chronic heart failure compared to those getting standard medical treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | ISAR Klinikum Academic / other |
| Locations | 1 site (Astana) |
| Trial ID | NCT06705023 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of a single injection of uncultured, autologous, adipose-derived regenerative cells (UA-ADRCs) in patients with chronic congestive heart failure and a left ventricular ejection fraction (LVEF) of 40% or less. The cells are isolated from lipoaspirate at the point of care using a specialized system and injected retrograde into the coronary veins. The study compares the outcomes of this treatment against patients receiving the best medical therapy. The primary focus is on improving cardiac function as measured by advanced imaging techniques and monitoring for any adverse cardiac events.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic congestive heart failure, LVEF of 40% or less, and stable on guideline-driven medical therapy.
Not a fit: Patients requiring immediate surgical intervention for heart failure or those with recent cardiac procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with severe heart failure.
How similar studies have performed: While this approach is innovative, similar studies using regenerative cells for heart failure have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Astana
- National Scientific Medical Center — Astana, Kazakhstan (Recruiting)
Study contacts
- Principal investigator: Abay Baigenzhin, Prof Dr — National Scientific Medical Center
- Study coordinator: Anastassiya Ganina-Smelova, PhD
- Email: anastassiya_smelova@mail.ru
- Phone: +77024346421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.