Study to Assess Safety and Efficacy of Treating Symptomatic, Ischemic, Chronic Congestive Heart F… (NCT06705023) | Clinical Trial Compass
RecruitingPhase 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.
Kazakhstan36 participantsStarted 2024-11-18
Plain-language 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
Age range21 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Left ventricular ejection fraction at 6 months assessed by cardiac MRI or cCT