NCT05797272Recruiting
In-utero Hematopoietic Stem Cell Transplantation for the Treatment of Fetuses With Bart's Hydrops Fetalis Syndrome
Feasibility of In-utero Hematopoietic Stem Cell Transplantation as a Conjunctive Treatment During In-utero Blood Transfusion for Hemoglobin Bart's Hydrops Fetalis Syndrome in Hong Kong
Source: ClinicalTrials.gov · Last updated 12 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 7 Mar 2023
- Start date
- 1 Oct 2021
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Chinese University of Hong Kong
- NCT number
- NCT05797272
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Oct 2021 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Fetuses diagnosed with in-utero death prior to the actual intervention.
Other illness
- 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;
Age
- Maternal age \< 18 years, mentally handicapped or severely ill;
Other
- 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;
- Maternal subjects:
- Unable to understand English or Chinese to give consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.