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.
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
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
Parallel
Uncultured, autologous, adipose-derived regenerative cells (UA-ADRCs)
Biological/VaccineIntracardial venous injection of fresh, uncultured, autologous, adipose-derived regenerative cells isolated from lipoaspirate at the point of care.
Continuation of patient's best guideline based medical treatment
Other interventionPatients will receive continuation of their best guideline based medical treatment.
Left ventricular ejection fraction at 6 months assessed by cardiac MRI or cCT
Change / Increase in cardiac function (LVEF from baseline to 6 month follow-up). Treatment success is defined as ≥15% increase in LVEF assessed by cMRI or cCT if cMRI is not feasible.
n-terminal pro-b-type natriuretic peptide
Assessment of n-terminal pro-b-type natriuretic peptide in the blood samples of the patients.
6-min walk test
A validated, sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Scar tissue assessment only in patients with cMRI
Only in patients with cMRI: relative amount of left ventricular scar tissue, left ventricular bull's eye segmental contracting areas.
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) score
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of lifescore will be applied to the patients.
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Ralf Rothoerl
Lead sponsor
ISAR Klinikum
Sponsor institution
National Scientific Medical Center, Kazakhstan
Collaborator
Internationnal Foundation Medicine and Science
Collaborator
Alliance of Cardiovascular Researchers
Collaborator
