MSC Exosome Therapy for Post-Preeclampsia Endothelial Dysfunction

ConditionsPreeclampsia Postpartum Endothelial Injury Exosome Multiomics Cell Therapy

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexFemale

Age18-50

SponsorUniversitas Padjadjaran

About this trial

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Why Is This Study Being Done?

Women who have preeclampsia during pregnancy face a much higher risk of heart disease later in life. Preeclampsia is a serious pregnancy condition that causes high blood pressure and damages blood vessels. Even after the baby is born, the blood vessels do not fully heal on their own, which can lead to heart problems/cardiovascular years later.

This study tests whether a new treatment called exosomes can help repair damaged blood vessels in women who had preeclampsia. Exosomes are tiny particles that come from stem cells and contain healing substances that may help blood vessels work better.

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What Will Happen in This Study?

This study will include 80 women who recently gave birth and had preeclampsia during their pregnancy. Half of the women will receive the exosome treatment through an IV, and half will receive a placebo (a substance with no active treatment).

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What Will Participants Need to Do?

Participants will:

* Have blood tests and other health checks * Receive one treatment through an IV * Return for follow-up visits at 1 week after treatment * Have tests to check how well their blood vessels are working

Who Can Join This Study?

Women who:

* Recently gave birth (within 1-2 weeks) * Had preeclampsia during their last pregnancy * Are healthy enough to participate * Can give permission to join the study

What Are the Possible Benefits and Risks?

The treatment may help repair blood vessel damage and reduce the risk of future heart disease. The exosome treatment appears to be safe based on other studies, but like any medical treatment, there may be side effects.

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How Long Will the Study Last?

The main treatment happens during one visit, with follow-up visits for 1 week to check on participants' health and see if the treatment is working.

This research may lead to new ways to protect women's heart health after pregnancy complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postpartum

Confirmed diagnosis of preeclampsia in the last pregnancy

Postpartum period of first week and second week

Able to provide informed consent

Disqualifiers

History of chronic hypertension prior to pregnancy

Major cardiovascular disease history

Active systemic infection

Endothelial Injury history

Trial design

Design model

Parallel

Treatments tested in this trial

Mesenchymal Stem Cell-Derived Exosomes
Biological/Vaccine
Mesenchymal stem cell-derived exosomes isolated from adipose-derived stem cells (ASC). The exosomes contain bioactive molecules including microRNAs (particularly miR-126-3p), proteins, and lipids that promote endothelial repair and regeneration. The product is manufactured under GMP conditions and administered as a single Intravenous or Intramuscular infusion.
Placebo (Sterile Saline Solution)
Other intervention
Sterile saline solution (0.9% sodium chloride) administered Intravenous or Intramuscular as placebo control. The volume and administration method are identical to the active treatment to maintain blinding.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: MSC-derived Exosome TherapyExperimental treatment 1 intervention

Group B: Saline/PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Endothelial Function Biomarker (miR-126-3p)

Measure: Change in miR-126-3p expression levels from baseline to 1 week post-intervention. Method: RT-PCR analysis of blood samples. Unit: Fold change (relative expression). Scale Description: Continuous variable measured as fold change relative to baseline. Higher values indicate improved endothelial function. Normal range: 0.8-1.2 fold change. Values \<0.8 indicate dysfunction.

Time frame

Baseline and 1 week post-intervention

Secondary outcomes

Systolic Blood Pressure

Measure: Change in systolic blood pressure from baseline. Unit: mmHg. Normal Range: 90-140 mmHg (postpartum). Values ≥140 mmHg indicate hypertension.

Time frame

Baseline, first week, and 1 week post-intervention

Diastolic Blood Pressure

Measure: Change in diastolic blood pressure from baseline. Unit: mmHg. Normal Range: 60-90 mmHg (postpartum). Values ≥90 mmHg indicate hypertension.

Time frame

Baseline, first week, and 1 week post-intervention

Hemoglobin Level

Measure: Change in hemoglobin concentration from baseline. Unit: g/dL. Normal Range: 11.0-15.0 g/dL (postpartum). Values \<11.0 g/dL indicate anemia.

Time frame

Baseline and 1 week post-intervention

Hematocrit Level

Measure: Change in hematocrit percentage from baseline. Unit: Percentage (%). Normal Range: 33-45% (postpartum). Values \<33% indicate anemia.

Time frame

Baseline and 1 week post-intervention

Other outcomes

Number of participants with clinically significant abnormal laboratory test results

Number and percentage of participants with ≥1 clinically significant abnormal laboratory result after baseline. "Clinically significant" = laboratory value outside normal reference range and meeting pre-specified criteria in protocol (investigator-assessed clinically important change). Each participant counted once regardless of number of abnormal tests.

Time frame

Baseline to 7 days after last dose of exosomes.