Placenta organoids treatment in Preterm Birth and Preeclampsia and Pregnancy Loss - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Drug: Placenta organoids treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Chiara Tersigni
Phone Number: +390630157546
Email: chiara.tersigni@policlinicogemelli.it

Study Locations

Italy
- Lazio
  - Roma, Lazio, Italy, 00168
    - Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
    - Contact:
      
      Chiara Tersigni
      
      Phone Number: +390630157546
      
      Email: chiara.tersigni@policlinicogemelli.it
    - Principal Investigator:
      
      Chiara Tersigni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women with normal pregnancy (n=5) or complicated by:

miscarriage (n=5);
preeclampsia (n=5);
preterm delivery (n=5); afferent to the U.O.C. of Obstetrics of the Agostino Policlinico Universitario Agostino Gemelli IRCCS of Rome.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%)	From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
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)	From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
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)	From date of caesarean section until the development of placental organoids, until 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From date of caesarean section until the development of placental organoids, until 36 months
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	From date of caesarean section until the development of placental organoids, until 36 months
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	From date of caesarean section until the development of placental organoids, until 36 months
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).	From date of caesarean section until the development of placental organoids, until 36 months
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.	From date of caesarean section until the development of placental organoids, until 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Principal Investigator: Chiara Tersigni, MD, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Estimated)