Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Defects, Congenital
- Hypoplastic Left Heart Syndrome
- Pediatric Disorder
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: SafetyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 4 years
- Gender
- Both males and females
Description
This is a Phase I, open label safety study. Autologous cord blood mononuclear cells (stem cell containing, cord blood buffy coat fraction) will be delivered by coronary infusion during the Norwood cardiopulmonary bypass operation in 12 antenatally diagnosed HLHS patients within 2-3 days of birth. Sa...
This is a Phase I, open label safety study. Autologous cord blood mononuclear cells (stem cell containing, cord blood buffy coat fraction) will be delivered by coronary infusion during the Norwood cardiopulmonary bypass operation in 12 antenatally diagnosed HLHS patients within 2-3 days of birth. Safety and clinical status monitoring will performed to Stage II surgical intervention for HLHS (at approximately 3 months of age). Treated patients will be continue to be assessed during follow up between Stage II and III (Fontan) surgical interventions.
Tracking Information
- NCT #
- NCT03431480
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Salvatore Pepe Melbourne Children's Campus (incorporating The Royal Children's Hospital, Murdoch Children's Research Institute, the University of Melbourne Department of Paediatrics) Principal Investigator: Christian P Brizard Melbourne Children's Campus (incorporating The Royal Children's Hospital, Murdoch Children's Research Institute, the University of Melbourne Department of Paediatrics)
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