The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNS) collected from bone marrow (BM) and using an add-on intramyocardial delivery for individuals with Ebstein anomaly undergoing surgical intervention compared to the control group undergoing the same surgical procedure without cell delivery. This add-on procedure has the potential to foster a new strategy for individuals with congenital heart disease.This is an open-label study of autologous MNC derived from bone marrow with a 2-year follow-up to document 1) incidence and severity of adverse event and 2) monitor changes in cardiac structure and function.
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Number of adverse events from time of index procedure
Timeframe: 24 months post index procedure
Severity of adverse events from time of index procedure
Timeframe: 24 months post index procedure
Number of subjects who died
Timeframe: 24 months post index procedure
Number of subjects with sustained symptomatic cardiac arrhythmias
Timeframe: 24 months post index procedure
Number of subjects with myocardial infarction
Timeframe: 24 months post index procedure
Number of subjects with unexpected, invasive cardiovascular procedures
Timeframe: 24 months post index procedure
Number of serious adverse events
Timeframe: 24 months post index procedure
Percentage of subjects in the treatment group that have cells delivered
Timeframe: 24 months post index procedure
Percentage of subjects in the treatment group completing the 24 month follow-up
Timeframe: 24 months post index procedure
Incidence of cardiac related hospitalizations from time of Ebstein repair
Timeframe: 1, 6, and 24 months post index procedure
Incidence of cardiac arrhythmias from time of index procedure
Timeframe: 1, 6, and 24 months post index procedure
Change in CT derived right ventricular dimensions from time of pre-operative evaluation
Timeframe: 6 and 24 months post index procedure
Change in echocardiography derived cardiac output from time of pre-operative evaluation
Timeframe: 1, 6, and 24 months post index procedure
Change in NT-Pro-BNP derived cardiac function trend from time of pre-operative evaluation
Timeframe: During hospitalization up to 29 days, 1, 6 and 24 months post index procedure
Incidence of cardiac related hospitalizations in the treatment group from time of pre-operative evaluation compared to the control group
Timeframe: 1, 6, and 24 months post index procedure
Incidence of cardiac arrhythmias in the treatment group from time of pre-operative evaluation compared to the control group
Timeframe: 1, 6, and 24 months post index procedure
Change in MRI derived cardiac output in the treatment group from time of pre-operative evaluation compared to the control group
Timeframe: 6 and 24 months post index procedure
Change in echocardiography derived right ventricular dimensions from time of pre-operative evaluation
Timeframe: 1, 6, and 24 months post index procedure
Change in NT-Pro-BNP derived cardiac function trend in the treatment group from time of pre-operative evaluation compared to the control group
Timeframe: During hospitalization up to 29 days, 1, 6, and 24 month post index procedure
Number of serious adverse events from time of enrollment
Timeframe: index procedure
Percentage of subjects in the treatment group whose cells meet all release criteria
Timeframe: 24 months post index procedure
Change in CT derived cardiac output from time of pre-operative evaluation
Timeframe: 6 and 24 months post index procedure
Change in MRI derived right ventricle ejection fraction in the treatment group from time of pre-operative evaluation compared to the control group
Timeframe: 6 and 24 months post index procedure
Change in MRI derived right ventricular dimensions in the treatment group from time of pre-operative evaluation compared to the control group
Timeframe: 6 and 24 months post index procedure
Change in CT derived right ventricle ejection fraction from time of pre-operative evaluation
Timeframe: 6 and 24 months post index procedure