Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06893978

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica

Rome, Lazio, 00168, Italy

Location contact

Chiara Tersigni

CONTACT

[email protected]

+390630157546

Chiara Tersigni, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placenta organoids treatment

Drug

Placenta organoids in vitro treatment with heparin, aspirin, IVIG, filgrastim and metformin

Primary outcomes

  1. Development of placental 3D organoid model

    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 (%)

  2. Characterization of placental 3D organoid model

    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)

  3. Viability of Placental Organoids

    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)

Secondary outcomes

  1. Gene Expression in Placental Organoids

    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)

  2. Secretome Analysis of Placental Organoids

    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

  3. Proliferative Capacity of Placental Organoids

    Time frame: From date of caesarean section until the development of placental organoids, until 36 months

    Assessment of percentage of proliferating cells

  4. Growth capacity of placental organoids

    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).

  5. Protein expression in placental organoids

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Tersigni

CONTACT

[email protected]

+390630157546

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: PLORG

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.