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

Recruiting now · Not applicable

Conditions studied: Haemoglobin Barts Hydrops

In brief

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.

Key facts

Study ID

NCT05797272

Run by

Chinese University of Hong Kong

People needed

10

Starts

2021-10-01

Expected to finish

2027-09-30

Last updated by the study team

2023-04-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 harvest and fetal intervention including, but not limited to, bleeding disorder, maternal cardiac disease, maternal mirror syndrome, symptomatic maternal anemia, or if they develop preterm premature rupture of membranes or active preterm labor;
• Unable to understand English or Chinese to give consent.

Where it is running

• The Chinese University of Hong Kong — Shatin, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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