Safety and Effectiveness of Autologous Adipose-derived Regenerative Cell Injection for Treating Chronic Ischemic Heart Failure with Low Heart Function

What this Trial Is About

Researchers are investigating the safety and effectiveness of a new treatment for patients with ischemic heart failure iHF who have a left ventricular ejection fraction LVEF of 40% or less despite receiving the best medical care. This study compares a single injection of fresh, uncultured, autologous adipose-derived regenerative cells UA-ADRCs isolated from a patients own fat tissue, delivered through a small balloon catheter into a coronary vein, against the continuation of the best guideline-based medical treatment. The goal is to see if this cell-based therapy improves heart function more than standard treatment. The study involves two groups one group of 24 patients will undergo a liposuction procedure to collect fat tissue, from which UA-ADRCs will be isolated using the Transpose RT Matrase System and then injected into the heart veins using a balloon catheter. The other group of 12 patients will continue with their regular medical treatment without the cell therapy. Follow-up visits are scheduled at 1, 3, and 6 months after treatment, and patients in the control group may later receive the stem cell therapy if they complete these visits. Additionally, all participants may join a long-term registry study with follow-ups at 12 and 24 months. During follow-up visits, participants will undergo cardiac MRI or CT scans, physical exams including echocardiography, answer questionnaires about their quality of life, and have their medication use and hospitalizations monitored. The primary measure of treatment success is a 15% or greater improvement in LVEF at 6 months. Secondary assessments include blood tests, a 6-minute walk test, scar tissue evaluation for MRI patients, heart failure symptom scores, and monitoring for any serious heart-related adverse events. The total study duration includes 6 months of individual follow-up after enrollment.

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.