Placenta organoids treatment: Placenta organoids in vitro treatment with heparin, aspirin, IVIG, filgrastim and metformin
Study summary
Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Women with uncomplicated normal term pregnancy undergoing elective cesarean section for previous uterine surgery or breech presentation of the fetus;
* Patients with retained abortion and history of recurrent abortion sine causa at the end of the work-up of investigations performed according to ESHRE guidelines, undergoing revision of the uterine cavity;
* Patients diagnosed with preeclampsia, defined in accordance with the definitions of ISSHP, undergoing cesarean section;
* Patients with preterm onset, before 37 weeks gestational age, of spontaneous labor, undergoing cesarean section in labor for low weight or abnormal fetal presentation.
Exclusion Criteria:
* Age \<18 years;
* Chronic infection with HIV or HCV;
* Ongoing malignant neoplasms;
* Multiple pregnancies;
* Inability to provide informed informed consent.
Primary outcome measure(s)
Development of placental 3D organoid model — From the date of caesarean section until the development of placental organoids, assessed up to 36 months. Morphological characteristics of placental 3D organoids successfully developed from placentas obtained from full-term physiological pregnancies and pathological conditions (abortion, preeclampsia, preterm delivery).
Assessment Parameters: Organoid formation efficiency (%)
Characterization of placental 3D organoid model — From the date of caesarean section until the development of placental organoids, assessed up to 36 months. Assessment of cell viability (live/dead staining)
Viability of Placental Organoids — From date of caesarean section until the development of placental organoids, until 36 months Measurement of cell proliferation rate in normal and pathological placental organoids before and after anticoagulant, anti-inflammatory, and immunomodulatory treatments (heparin, aspirin, metformin, IVIg, filgrastim).
Assessment Parameters: Cell viability (live/dead staining)
Trial sites (1)
Facility
City
Region
Status
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
Rome
Lazio
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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