The Effectiveness of Mesenchymal Stem Cell-Derived Exosome Therapy in Improving Endothelial Dysfunction in Postpartum Mothers With a History of Preeclampsia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Endothelial Function Biomarker (miR-126-3p)
研究概览
简要总结
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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.
详细描述
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Background and Rationale
Preeclampsia affects 3-5% of pregnancies globally and represents a severe pregnancy-specific syndrome characterized by widespread maternal endothelial dysfunction. The pathophysiology involves abnormal trophoblast invasion leading to placental ischemia. Beyond immediate perinatal risks, preeclampsia carries devastating long-term cardiovascular consequences, with women experiencing a four-fold increased risk of heart failure, a 2.5-fold increased risk of coronary heart disease, and a two-fold increased risk of stroke and cardiovascular death. Moreover, post-cesarean postpartum mothers with a history of preeclampsia face particularly elevated risks, with cesarean delivery increasing postpartum preeclampsia risk by two- to seven-fold compared to vaginal delivery. This increased risk stems from altered hemodynamics, surgical stress responses, and compromised vascular integrity following cesarean procedures.
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Scientific Innovation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum
- •Confirmed diagnosis of preeclampsia in the last pregnancy
- •Postpartum period of first week and second week
- •Able to provide informed consent
排除标准
- •History of chronic hypertension prior to pregnancy
- •Major cardiovascular disease history
- •Active systemic infection
- •Endothelial Injury history
- •Active smoking status including vape, alcohol, drug addiction.
研究组 & 干预措施
MSC-derived Exosome Therapy
Participants receive Intravenous or Intramuscular MSC-derived exosomes.
干预措施: Mesenchymal Stem Cell-Derived Exosomes (Biological)
Saline/Placebo
Participants receive Intravenous or Intramuscular sterile saline solution
干预措施: Placebo (Sterile Saline Solution) (Other)
结局指标
主要结局
Change in Endothelial Function Biomarker (miR-126-3p)
时间窗: Baseline and 1 week post-intervention
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.
次要结局
- Systolic Blood Pressure(Baseline, first week, and 1 week post-intervention)
- Diastolic Blood Pressure(Baseline, first week, and 1 week post-intervention)
- Hemoglobin Level(Baseline and 1 week post-intervention)
- Hematocrit Level(Baseline and 1 week post-intervention)
- Leukocyte Count(Baseline and 1 week post-intervention)
- Platelet Count(Baseline and 1 week post-intervention)
- Mean Corpuscular Volume (MCV)(Baseline and 1 week post-intervention)
- Mean Corpuscular Hemoglobin Concentration (MCHC)(Baseline and 1 week post-intervention)
- Proteinuria Level(Baseline and 1 week post-intervention)
- Uterine Artery Pulsatility Index (PI)(Baseline and 1 week post-intervention)
- Uterine Artery Resistance Index (RI)(Baseline and 1 week post-intervention)
- Heart Rate(Baseline, first week, and 1 week post-intervention)
- Respiratory Rate(Baseline, first week, and 1 week post-intervention)
- Upper Extremity Edema Grade(Baseline and 1 week post-intervention)
- Lower Extremity Edema Grade(Baseline and 1 week post-intervention)
- Facial Edema Grade(Baseline and 1 week post-intervention)
- Uterine Involution Status(Baseline and 1 week post-intervention)