| Eligibility |
Inclusion Criteria:
- Be = 21 and < 80 years of age.
- Provide written informed consent.
- Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to MI as
defined by previous myocardial infarction documented by an imaging study demonstrating
coronary artery disease with corresponding areas of akinesis, dyskinesis, or severe
hypokinesis.
- Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
- Have been treated with appropriate maximal medical therapy for heart failure or
postinfarction left ventricular dysfunction. For beta-blockade, the patient must have
been on a stable dose of a clinically appropriate beta-blocker for 3 months. For
angiotensinconverting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)
or angiotensin receptor neprilysin inhibitors (ARNIs) or have appropriate medical
indication precluding use of one or both of these agents, the patient must have been
on a stable dose of a clinically appropriate agent for 1 month or within no more than
doubling the dose of any of ARB, ACE inhibitors, and ARNIs over the last 3 months.
- Left ventricular ejection fraction below 40%.
- Class II/III NYHA symptoms of heart failure within the 6 months prior to baseline
testing.
- Hospitalization in the past 6 months or NT pro-BNP > 1200 pg/mL, or >1600 pg/mL if
atrial fibrillation was present.
- Automated implantable cardioverter-defibrillator (AICD) in place.
Exclusion Criteria:
- Have a baseline glomerular filtration rate < 35 ml/min/1.73 m2
- Have a known, serious radiographic contrast allergy.
- Have a prosthetic aortic valve or heart constrictive device.
- Have a documented presence of aortic stenosis (aortic stenosis graded as 1.5 cm2 or
less).
- Have a documented presence of moderate to severe aortic insufficiency
(echocardiographic assessment of aortic insufficiency graded as =+2).
- Have evidence of a life-threatening arrhythmia in the absence of a defibrillator
(nonsustained ventricular tachycardia = 20 consecutive beats or complete second- or
third-degree heart block in the absence of a functioning pacemaker) or QTc interval >
550 ms on screening ECG.
- AICD firing in the past 60 days prior to enrollment.
- Be eligible for or require coronary artery revascularization.
- Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell <
2,500/µl, or platelet values < 100,000/µl without another explanation.
- Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times
the ULN.
- Have a coagulopathy (INR > 1.3) not due to a reversible cause (i.e., Coumadin).
Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed to
have an INR < 1.3. Patients who cannot be withdrawn from Coumadin will be excluded
from enrollment.
- Have known allergies to penicillin or streptomycin.
- Be an organ transplant recipient.
- Have a history of organ or cell transplant rejection.
- Have a clinical history of malignancy within 5 years (i.e., patients with prior
malignancy must be disease-free for 5 years), except curatively-treated basal cell
carcinoma, squamous cell carcinoma, or cervical carcinoma.
- Have a non-cardiac condition that limits lifespan to < 1 year.
- Be on chronic therapy with immunosuppressant medication, such as corticosteroids or
TNFa antagonists.
- Be serum-positive for HIV, hepatitis BsAg, or viremic hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an
investigational therapeutic or device trial.
- Be a female patient who is pregnant, nursing, or have child-bearing potential but is
not using effective birth control.
- Tested positive for SARS-CoV-2 within the last 30 days
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