MSC exosome treatment to repair blood vessel damage after preeclampsia
The Effectiveness of Mesenchymal Stem Cell-Derived Exosome Therapy in Improving Endothelial Dysfunction in Postpartum Mothers With a History of Preeclampsia
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Universitas Padjadjaran Academic / other |
| Locations | 1 site (Bandung, West Java) |
| Trial ID | NCT07183384 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bandung, West Java
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.