Clinical Trials

Inclusion Criteria:

• Diagnosis of coronary endothelial dysfunction based on coronary angiogram and acetylcholine comprehensive coronary physiology study.
• Able to provide informed written consent and willing to participate in all required study follow-up assessments.

Exclusion Criteria:

• Acute coronary syndrome or continuous/ongoing chest pain - unremitting and unresponsive to nitroglycerin or rest - persisting 4 or more days before stent placement. If the chest pain syndrome is transient and/or intermittent - even if it began more than 3 days prior to admission - the patient is not excluded.
• Subjects in cardiogenic shock (systolic pressure < 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
• Subjects unable to receive antiplatelet agents (e.g. aspirin, clopidogrel, ticlopidine,prasugrel, etc).
• Abnormal laboratory values (Hgb <11 mg/dL; glomerular filtration rate (GFR)<50; liver function tests (LFTs)>2x upper limit of normal).
• Subjects receiving warfarin who have an international normalized ratio (INR) >2 at the end of the screening phase or with major bleeding requiring active transfusion support.
• Subjects with severe cardiac valvular disease expected to undergo surgery within 1 year.
• Subjects with known severe immunodeficiency states (AIDS).
• Significant coronary artery disease on coronary angiogram.
• Cirrhosis requiring active medical management.
• Malignancy requiring active treatment (except basal cell skin cancer).
• Subjects with documented active alcohol and /or other substance abuse.
• Females of child bearing potential unless a pregnancy test is negative within 7 days of the bone marrow harvest.
• Re-occlusion of the infarct related artery (IRA) prior to the infusion procedure.
• Planned revascularization intervention during the next 6 months. (A second PCI can be performed if done prior to qualifying cardiovascular magnetic resonance imaging (CMR) at least 96 hours post primary PCI).
• Participation in an ongoing investigational trial.
• Active or suspected bacterial infection requiring systemic intravenous antibiotics.
• Additional factors deemed unsuitable for trial enrollment per discretion of principal investigator.
• Inmates.