Autologous Umbilical Cord Blood Treatment of Neonate With CHD

Summary

Participation Requirements

Description

The aim of this pilot study is to evaluate the safety and feasibility of infusion of autologous umbilical cord blood (UCB) in neonates with with hypoplastic left heart syndrome (HLHS) or transposition of great arteries (TGA). This is a prospective, matched control study, Phase I-II trial to evaluate...

The aim of this pilot study is to evaluate the safety and feasibility of infusion of autologous umbilical cord blood (UCB) in neonates with with hypoplastic left heart syndrome (HLHS) or transposition of great arteries (TGA). This is a prospective, matched control study, Phase I-II trial to evaluate the safety and efficacy of autologous UCB infusion in neonates with HLHS or TGA. The study group will consist of neonate that were diagnosed by prenatal fetal ultrasound with HLHS or TGA and their UCB was collected at the time of delivery. The study group will include the patients with UCB and the control group will be patients without UCB. All patients will have their surgery within 2 weeks from birth. The UCB will be infused to the patients in study group as soon as the patient has stabilized after the surgery and not more than 7 days after surgery. Both groups will be followed similarity: During hospitalization: Neurological and cardiac evaluation a day before surgery, 7 days after surgery and at discharge. Blood tests for immune and growth factors a day before surgery, at the time of infusion (or intended infusion for the control group) ,1 and 7 days after infusion. have a cardiac and brain MRI before the surgery and within 14 days after surgery. Brain and cardiac MRI before surgery, 7-14 days after surgery. Ambulatory follow up (similar to routine follow up): Cardiac and neuro-developmental evaluation at 1,6,12 month Blood tests for immune and growth factors at 1 month

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