drugset / Trial / NCT03558269

Autologous Umbilical Cord Blood Treatment of Neonate With CHD

NCT03558269

Phase 1/2 Unknown 60 enrolled Sheba Medical Center
Non-randomizedParallel-groupSingle-blindTreatment

Summary

The aim of the study is to evaluate the feasibility and safety and efficacy of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS) and transposition of great arteries (TGA). Rationale: Neonates with HLHS and TGA have significant brain injury as demonstrated by peri-surgical MRI. Moreover, there a substantial tendency to suffer from chronic cardiac condition as low cardiac output state and valvular insufficiency. Treatment of neonates after hypoxic ischemic injury at birth with autologous UCB was shown to safe and improved developmental outcome. The effect of UCB is most likely achieved by reduction of free radicals injury and pro-inflammatory and apoptotic process. Hypothesis: Treatment with UCB immediately after the first cardiac surgey, with in the first week life will reduce the brain injury demonstrated by MRI and reduce the choronic cardiac problems

Timeline

Start
2019-02-01
Primary completion
2021-05-01
Completion
2023-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous cord blood Cell therapy