Retrograde Delivery of BMAC (Bone Marrow Aspirate Concentrate) for Congestive Heart Failure

Inclusion Criteria:

• Age ≥18 years and ability to understand the planned treatment.
• Patients with Congestive Heart Failure
• Left ventricular ejection fraction ≤40% by echocardiogram, per ECHO completed 30 days prior to treatment
• Symptomatic heart failure NYHA class III or IV
• Able to comply with all study-related visits
• Able to tolerate study procedures, including bone marrow aspiration, SPECT,
• Able to give informed Consent
• Negative for HcG with a serum pregnancy test
• Patients with controlled diabetes mellitus (HbA1c < 9.0%)
• Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000,
• Life expectancy of 6 months or more in the opinion of the investigator
• Patients requiring high dose corticosteroid therapy (more than 7.5 mg/day) with 1 month before the aspiration or 6 months after the infusion.
• Serum bilirubin, ALT, AST ≤2.5 time the upper level of normal.
• Controlled blood pressure (systolic blood pressure ≤140 and a diastolic blood pressure of ≤90 mmHG) and established anti-hypertensive therapy as necessary prior to entry into the study
• Patient has received stable, standard medical therapy for at least one month with no new medications to treat the disease introduced in the last 3 months.
• Pre-existing condition (e.g. thromboembolic risk, diabetes, hypercholesterolemia are adequately controlled in the opinion of the investigator)
• Fertile patients (male and female) must agree to use an appropriate form of contraception while participating in the study.

Exclusion Criteria:

• Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
• History of prior radiation exposure for oncological treatment.
• History of Bone Marrow Disorder (especially NHL, MDS) that prohibit transplantation.
• History of abnormal bleeding or clotting.
• History of Liver Cirrhosis.
• End stage renal disease (Creatinine ≤ 3.0 mg / dl) and/or dialysis
• Acute Myocardial Infarction < 1 week from treatment date.
• Active clinical infection being treated by antibiotics within one week of enrollment
• Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
• Unable to have 250cc bone marrow harvested.
• History of life-threatening arrhythmias, except if an automated implantable cardioverter defibrillator (AICD) is implanted
• Life expectancy <6 months due to concomitant illnesses
• Known cancer and undergoing treatment; chemotherapy and/or radiotherapy
• Patients receiving treatment with hematopoietic growth factors (e.g., EPO, G-CSF)
• Patients who can not stop anticoagulation therapy (warfarin) 72hrs prior to bone marrow aspiration and infusion
• Patients who can not stop anti-platelet therapy (clopidogrel) 7 days prior to bone marrow aspiration and infusion
• History of alcohol consumption exceeding the equivalent of 2 drinks/daily (1 drink = 5oz wine, 12oz of beer, or 1.5oz hard liquor) or illicit drug use within 6 months of screening.
• Patient who will require continuous high dose corticosteroid therapy (more than 7.5mg/day) within 1 month before aspiration or 6 months after injection procedure.
• Body Mass Index (BMI) of 40 kg/m2 or greater
• Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
• In the opinion of the investigator or the sponsor, the patient is unsuitable for cellular therapy
• Known allergy or sensitivity to contrast agents used in imaging procedures.