Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived … (NCT02549625) | Clinical Trial Compass
CompletedPhase 1
Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells
United States10 participantsStarted 2015-08
Plain-language summary
The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for individuals with declining performance of their single right ventricle systemic pumps. This procedure has the potential to foster a new strategy for congenital heart patients. This is an open-label study of autologous MNC derived from bone marrow with a 2-year follow-up to document 1) related serious adverse events and 2) monitor changes in cardiac structure and function.
Who can participate
Age range2 Years – 30 Years
SexALL
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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-sy…