Study to Assess Safety and Efficacy of Treating Symptomatic, Ischemic, Chronic Congestive
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 / Matrase System (InGeneron, Houston, TX,
| Condition(s) | Myocardial Injury, LV Dysfunction, Coronary Artery Disease, Heart Failure |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 / 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. |
| Who can participate | 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 procedur |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Lead sponsor | Ralf Rothoerl |
| Locations | Astana, Kazakhstan |
| Start date | 2024-11-18 |
| NCT ID | NCT06705023 |
| Official listing | https://clinicaltrials.gov/study/NCT06705023 |