Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
Rome, Lazio, 00168, Italy
NCT Number: NCT06893978
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Rome, Lazio, 00168, Italy
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placenta organoids in vitro treatment with heparin, aspirin, IVIG, filgrastim and metformin
Time frame: 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 (%)
Time frame: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
Assessment of cell viability (live/dead staining)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: From date of caesarean section until the development of placental organoids, until 36 months
Assessment of percentage of proliferating cells
Time frame: From date of caesarean section until the development of placental organoids, until 36 months
Assessment of organoid growth rate (diameter increase over time).
Time frame: From date of caesarean section until the development of placental organoids, until 36 months
Assessment of differential expression of proteins by Western blot, immunohistochemistry.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Acronym: PLORG
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