Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells

Inclusion Criteria:

• Individuals with Fontan circulation with right ventricular dysfunction
• Ejection fraction equal to or less than 40% despite optimal outpatient medical management for at least 3 months
• Able to undergo bone marrow aspirate according to clinical consultation with hematology (INR must be maintained at or below 1.5)
• Able to undergo an MRI or CT examination

Exclusion Criteria:

• Individuals or parents of minors unwilling to consent to participation
• Individuals with severe chronic diseases, extra-cardiac syndromes, or cancer
• Females 10 years and older with positive pregnancy test or lack of effective birth control method
• Individuals currently requiring IV inotropes
• Individuals with bleeding disorders or history of thrombosis
• Individuals not eligible for MRI and have elevated serum creatinine level (eGFR less that 45 mL/min) and therefore cannot have a CT examination
• Individuals not eligible for MRI and have a prior significant reaction to intravenous contrast required for CT examination

• Individuals with the following conditions within 60 days prior to procedure:

  • Cardiogenic shock or extracorporeal circulation;
  • New arrhythmia that required medication for control;
  • Documented infection requiring treatment with antibiotics, and/or current infection being treated with antibiotics;
  • Cardiac condition requiring emergency procedure;
  • Cardiovascular surgery;
  • Seizures or history of significant neurological injury;
  • Multi-system organ failure including acute or chronic renal failure