Healthy, Preeclampsia, Pregnancy Loss, Preterm Birth
Conditions
Brief 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.
Detailed description
Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization. Placental organoid model can be used in the study of placental pathophysiology. In in particular, it provides a personalized model for sartorial in vitro evaluation of personalized therapeutic efficacy of different pharmacological therapies. In particular, with placental organoid it is possible to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.
Interventions
DRUGPlacenta organoids treatment
Placenta organoids in vitro treatment with heparin, aspirin, IVIG, filgrastim and metformin
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth capacity of placental organoids | From date of caesarean section until the development of placental organoids, until 36 months | Assessment of organoid growth rate (diameter increase over time). |
| Gene Expression in Placental Organoids | From date of caesarean section until the development of placental organoids, until 36 months | Quantification of tissue-specific gene expression in normal and pathological placental organoids before and after treatments. Assessment Parameters: Differential expression of target genes (qPCR) |
| Protein expression in placental organoids | From date of caesarean section until the development of placental organoids, until 36 months | Assessment of differential expression of proteins by Western blot, immunohistochemistry. |
| Secretome Analysis of Placental Organoids | From date of caesarean section until the development of placental organoids, until 36 months | Analysis of extracellular vesicles and soluble factors secreted by placental organoids before and after treatments. Assessment Parameters: Quantification of cytokines by ELISA assay |
| Proliferative Capacity of Placental Organoids | From date of caesarean section until the development of placental organoids, until 36 months | Assessment of percentage of proliferating cells |
Countries
Italy
Contacts
Primary ContactChiara Tersigni
Outcome results
None listed