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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-11

Study Completion Date

2028-03-20

Brief Summary

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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.

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Detailed Description

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Preterm birth complicates 10% of all pregnancies and is the leading cause of perinatal morbidity and mortality worldwide. Among all PTB cases, 70% occur spontaneously (SPTB), while the remaining 30% are medically indicated due to severe intrauterine growth restriction (IUGR). Intra-amniotic inflammation (IAI) and chorioamnionitis are well-established causes of SPTB; 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.Recent studies have identified the activation of the NLRP3 inflammasome in human amniotic membranes (hAM) as a key mechanism in the pathogenesis of SPTB. Targeting NLRP3 as a therapeutic approach for inflammatory diseases is rapidly advancing. 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

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Preterm Birth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study is interventional because of maternal peripheral blood sampling

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Women with spontaneous preterm birth

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.

Group Type EXPERIMENTAL

Venous blood sampling

Intervention Type OTHER

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

Tissues sampling

Intervention Type OTHER

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

Umbilical cord blood sampling

Intervention Type OTHER

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

Women with medically induced preterm birth

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.

Group Type ACTIVE_COMPARATOR

Venous blood sampling

Intervention Type OTHER

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

Tissues sampling

Intervention Type OTHER

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

Umbilical cord blood sampling

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Venous blood sampling

Intervention Type OTHER

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

Tissues sampling

Intervention Type OTHER

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

Umbilical cord blood sampling

Intervention Type OTHER

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

Interventions

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Venous blood sampling

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

Intervention Type OTHER

Tissues sampling

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

Intervention Type OTHER

Umbilical cord blood sampling

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

Intervention Type OTHER

Eligibility Criteria

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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).