Last reviewed · How we verify

NCT06891508: PLACENTOMICS

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

Active, enrolled NA Last updated 24 March 2025
What this trial tests

NA trial testing Venous blood sampling in Preterm Birth in 60 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
11 March 2025
Primary endpoint
20 March 2026
20 March 2028

Quick facts

Lead sponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment60
Start date11 March 2025
Primary completion20 March 2026
Estimated completion20 March 2028
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, female only, with Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Venous blood sampling

Trials testing the same drug.

Other recruiting trials for Preterm Birth

Currently open trials in the same condition.

Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06891508.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing