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Clinical Trials in Italy / NCT06891508
Active, not recruiting Not applicable

The Placental Secretome as a Therapeutic Tool to Prevent Inflammation-induced Preterm Birth

NCT06891508 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Not applicable
Started
2025-03-11
Last updated
2025-03-24

Condition(s) studied

Preterm Birth

Investigational drug(s) / intervention(s)

Venous blood samplingTissues samplingUmbilical cord blood sampling

Venous blood sampling: Venous blood sampling (3 mL) via venipuncture from the antecubital fossa at the time of delivery

Tissues sampling: Sampling of the placenta and amniochorionic membranes (hAM) at delivery

Umbilical cord blood sampling: Umbilical cord blood sampling from the residual cord attached to the placenta immediately after clamping.

Study summary

Preterm birth complicates 10% of all pregnancies and is the leading cause of perinatal morbidity and mortality worldwide. Intra-amniotic inflammation (IAI) and chorioamnionitis are well-established causes of PTB; however, a treatable infectious trigger is identified in only 50% of cases.In sterile IAI and/or preterm premature rupture of membranes (pPROM), there are currently no effective therapeutic options to reduce inflammation, promote amniotic sac healing, and prevent preterm birth. Growing evidence suggests that the secretome of mesenchymal stem cells (MSC) exhibits immunomodulatory and tissue-regenerative properties, making it a promising therapeutic tool for inflammatory disorders. Specifically, the conditioned medium from human amniotic mesenchymal stromal cells (CM-hAMSC) has been successfully used to treat various preclinical inflammatory disease models.

The aims of this study will be:1) to evaluate the activation of the NLRP3 inflammasome in hAM cells and peripheral blood mononuclear cells (PBMCs) from women with PTB. 2)To investigate the effect of CM-hAMSC on NLRP3 activation induced by lipopolysaccharide (LPS) and nigericin in cultured human amniotic epithelial cells (hAECs), amniotic mesenchymal stromal cells (hAMSCs), and PBMCs.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Full-term uncomplicated pregnancy, without any medical conditions or ongoing pharmacological treatment (control group). * Pregnancy complicated by spontaneous preterm birth (gestational age 24-32 weeks). * Pregnancy complicated by medically indicated preterm birth (gestational age 24-32 weeks). Exclusion Criteria: * Age \<18 years * Chronic infections (HIV or HCV) * Cancer * Multiple pregnancy * Inability to provide informed consent

Primary outcome measure(s)

Trial sites (1)

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

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06891508 on ClinicalTrials.gov ↗ ← All trials in Italy