MSC exosome treatment to repair blood vessel damage after preeclampsia
Official title: The Effectiveness of Mesenchymal Stem Cell-Derived Exosome Therapy in Improving Endothelial Dysfunction in Postpartum Mothers With a History of Preeclampsia
Run by Universitas Padjadjaran · NCT07183384 · Data updated 2026-11-12
This study will see if IV infusions of mesenchymal stem cell–derived exosomes help repair damaged blood vessels in women who recently had preeclampsia.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Universitas Padjadjaran Academic / other |
| Locations | 1 site (Bandung, West Java) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | July 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | September 19, 2025 |
| Trial ID | NCT07183384 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women within the first two weeks postpartum with a confirmed diagnosis of preeclampsia in the recent pregnancy who can give informed consent and do not have prior chronic hypertension or major cardiovascular disease.
✕Probably not a fit
Patients with preexisting chronic hypertension, major cardiovascular disease, active systemic infection, or active substance use (including smoking or vaping) are excluded and would not be expected to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized Phase 1/2 trial will enroll 80 postpartum women with a confirmed recent diagnosis of preeclampsia and randomize them 1:1 to receive intravenous MSC-derived exosomes or placebo. Participants will undergo blood tests and vascular assessments during early postpartum follow-up to monitor safety and biological signals of endothelial repair. The protocol emphasizes short-term safety, tolerability, and evidence of improved endothelial function after treatment. Findings will inform whether larger trials are warranted to test clinical benefit.
Why it matters
Potential benefit: If successful, the treatment could promote endothelial repair after preeclampsia and potentially reduce long-term cardiovascular risk in affected women.
How similar studies have gone: Early-phase clinical work and preclinical studies of MSC-derived exosomes and related cell therapies have shown promising safety signals and vascular effects, but human data specifically for post-preeclampsia endothelial repair remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postpartum * Confirmed diagnosis of preeclampsia in the last pregnancy * Postpartum period of first week and second week * Able to provide informed consent Exclusion Criteria: * 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.
Where it's running
-
Dr. Hasan Sadikin Central General Hospital
Bandung, West Java, Indonesia Recruiting
Study contacts
- Principal investigator: Akhmad Y Pramatirta, M.D., Ph.D — Dr. Hasan Sadikin Central General Hospital
- Study coordinator: Prima N Fauziah, S.Si., M.Si.
- Email: primanandafauziah@gmail.com
- Phone: +62 85721368609
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.