Placental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology.

Not yet recruiting

• Conditions: Preeclampsia; Pregnancy Loss; Preterm Birth; Healthy

• Registration Number: NCT06893978
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-05-14
• Study Start: 2025-05-20
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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).
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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica; 🇮🇹 Roma, Lazio, Italy