Ensayos clínicos

Inclusion Criteria

• Age 1 to 30 years
• Clinically planned, elective surgical Ebstein repair
• Individuals able to undergo bone marrow aspirate according to clinical consultation with Hematology (cell treatment group only)
• Individuals able to undergo preoperative MRI or CT examination
• Individual and/or parent willing and able to give informed consent and willing to commit to completion of follow-up

Exclusion Criteria

• Individuals requiring cavopulmonary shunt at the time of surgical Ebstein repair; planned preoperatively or required intraoperatively
• Individuals with, or reasonably expected to have, complications during surgical Ebstein repair or during post-operative recovery
• Individual has not completed or will not be completing all pre-procedure work-up within 30 days of surgical Ebstein repair as listed in section 6 of this protocol AND lack of pre-procedure work-up documented as a safety concern by a site investigator
• Other clinical concerns as documented by a site investigator that could reasonably increase the risk of complications during or after surgical Ebstein repair
• Individual whose cells have been determined, by the sponsor, to not be acceptable for release to the investigational site or individual whose cells have been compromised after cells released to investigational site (cell treatment group only)
• Individuals who require surgery on pulmonary, mitral, or aortic valve
• Individuals with pulmonary atresia or atrioventricular discordance with ventriculoarterial discordance