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This is an investigational autologous cell therapy consisting of mononuclear cells derived from the patient's own umbilical cord blood (CBMNCs). Developed by the Murdoch Children's Research Institute, the therapy is designed to treat newborns with hypoplastic left heart syndrome (HLHS). The cells are collected at birth and delivered via intracoronary infusion during the Norwood operation (Stage I palliation), typically on days 2-3 of life. The primary goal is to support right ventricular myocardial remodeling and improve cardiac function during the critical interstage period. A Phase I study (NCT03431480) has demonstrated the safety and feasibility of delivering these non-cryopreserved cells during cardioplegic arrest without prior cryopreservation.
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