NCT05797272 In-utero Hematopoietic Stem Cell Transplantation for the Treatment of Fetuses With Bart's Hydrops Fetalis Syndrome

Trial Parameters

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Brief Summary

This is a prospective observational pilot study on pregnant women who are diagnosed to have Bart's hydrops fetalis syndrome (BHFS) affected fetuses and opt for continuation of pregnancy will be invited to consider undergoing in-utero hematopoietic stem cell transplantation under a research protocol, aiming to determine whether in-utero hematopoietic stem cell transplantation (HSCT) for fetuses with confirmed BHFS at the time of in-utero transfusion (IUT) of red blood cells could be feasible in Hong Kong. The participants will undergo bone marrow or peripheral blood stem cells harvest and an IUT combined with maternal stem cells.

Eligibility Criteria

Inclusion Criteria: * Pregnancy before 26 weeks and 0 day of gestational age with a diagnosis of BHFS confirmed by chorionic villus sampling, amniocentesis or cordocentesis; * The parents elected to pursue IUT and are willing to undergo subsequent IUT for the remainder of gestation. Exclusion Criteria: A) Fetal subjects: * Fetuses having a second major anatomic anomaly (not related to the underlying thalassemia) that contributes a significant morbidity or mortality risk; * Fetuses having a genetic or chromosomal abnormalities other than BHFS that contributes a significant morbidity or mortality risk; * Echocardiogram or ultrasound findings that indicate a high risk of fetal demise after fetal intervention; * Fetuses diagnosed with in-utero death prior to the actual intervention. B) Maternal subjects: * Maternal age \< 18 years, mentally handicapped or severely ill; * Maternal participants having one or more morbidities that would preclude bone marrow or peripheral blood stem cells harv

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