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The Placental Secretome as a Therapeutic Tool to Prevent Inflammation-induced Preterm Birth
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Official title: The Placenta-derived Secretome of Mesenchymal Stromal Cells as a Therapeutic Tool to Prevent Inflammation-induced Preterm Birth
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-03-11
Completion Date
2028-03-20
Last Updated
2025-03-24
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
Rome, Lazio, Italy