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.

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.

Eligibility

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.

Conditions5

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