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

NCT06891508 | Active Not Recruiting

• 1 other identifier: 7273
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Anti-inflammatory effects of conditioned medium

  To investigate the effect of CM-hAMSC on NLRP3 activation induced by lipopolysaccharide (LPS) and nigericin in cultured hAECs, hAMSCs, and PBMCs

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Inflammasome activation

  Through study completion, an average of 1 year

Study Arms (3)

Women with spontaneous preterm birth

EXPERIMENTAL

Women enrolled in this study will undergo a venous blood draw (3 mL) via venipuncture from the antecubital fossa at the time of delivery. The placenta and amniochorionic membranes (hAM) will be collected within 30 minutes after delivery, performed via cesarean section. Additionally, a 3 mL sample of umbilical cord blood will be drawn from the residual cord attached to the placenta immediately after clamping.

Other: Venous blood sampling; Other: Tissues sampling; Other: Umbilical cord blood sampling

Women with medically induced preterm birth

ACTIVE COMPARATOR

Women enrolled in this study will undergo a venous blood draw (3 mL) via venipuncture from the antecubital fossa at the time of delivery. The placenta and amniochorionic membranes (hAM) will be collected within 30 minutes after delivery, performed via cesarean section. Additionally, a 3 mL sample of umbilical cord blood will be drawn from the residual cord attached to the placenta immediately after clamping.

Other: Venous blood sampling; Other: Tissues sampling; Other: Umbilical cord blood sampling

Healthy women with at least two previous uncomplicated pregnancies

ACTIVE COMPARATOR

Women enrolled in this study will undergo a venous blood draw (3 mL) via venipuncture from the antecubital fossa at the time of delivery. The placenta and amniochorionic membranes (hAM) will be collected within 30 minutes after delivery, performed via cesarean section. Additionally, a 3 mL sample of umbilical cord blood will be drawn from the residual cord attached to the placenta immediately after clamping.

Other: Venous blood sampling; Other: Tissues sampling; Other: Umbilical cord blood sampling

Interventions

Venous blood sampling OTHER

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

Healthy women with at least two previous uncomplicated pregnancies; Women with medically induced preterm birth; Women with spontaneous preterm birth

Tissues sampling OTHER

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

Healthy women with at least two previous uncomplicated pregnancies; Women with medically induced preterm birth; Women with spontaneous preterm birth

Umbilical cord blood sampling OTHER

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

Healthy women with at least two previous uncomplicated pregnancies; Women with medically induced preterm birth; Women with spontaneous preterm birth

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Age \<18 years
• Chronic infections (HIV or HCV)
• Cancer
• Multiple pregnancy
• Inability to provide informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

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

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Blood Specimen Collection; Cordocentesis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Paracentesis; Therapeutics

Study Officials

• Chiara Tersigni, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is interventional because of maternal peripheral blood sampling

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 24, 2025
• Study Start: March 11, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): March 20, 2028
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)