NCT07183384RecruitingPhase 1/2
MSC Exosome Therapy for Post-Preeclampsia Endothelial Dysfunction
The Effectiveness of Mesenchymal Stem Cell-Derived Exosome Therapy in Improving Endothelial Dysfunction in Postpartum Mothers With a History of Preeclampsia
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
\--- 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. \--- 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). \--- 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. \--- 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 2 Sept 2025
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Universitas Padjadjaran
- NCT number
- NCT07183384
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- From 1 Jul 2024 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of chronic hypertension prior to pregnancy
- Active smoking status including vape, alcohol, drug addiction.
Other illness
- Major cardiovascular disease history
- Active systemic infection
Other
- Endothelial Injury history
Who the study is looking for
- Postpartum
- Confirmed diagnosis of preeclampsia in the last pregnancy
- Postpartum period of first week and second week
- Able to provide informed consent
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Hasan Sadikin Central General Hospital Coordinator of this site? Confirm its status | Bandung | Indonesia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.