Correlation between cell-free mRNA expressions and PLGF protein level in severe preeclampsia.
Akhmad Yogi Pramatirta, Johannes Mose, Jusuf S Effendi...
https://pubmed.ncbi.nlm.nih.gov/26032325Actively Recruiting
Led by Universitas Padjadjaran · Updated on 2025-09-19
80
Participants Needed
1
Research Sites
8 weeks
Total Duration
U
Universitas Padjadjaran
Lead Sponsor
D
Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
Collaborating Sponsor
Women who have experienced preeclampsia during pregnancy face a higher risk of heart disease later in life due to lasting damage to blood vessels. This trial evaluates whether a new treatment using mesenchymal stem cell-derived exosomes can help repair blood vessel damage in postpartum women with a history of preeclampsia. Preeclampsia causes high blood pressure and endothelial dysfunction, leading to serious long-term cardiovascular risks. Participants will receive either a single dose of exosome therapy or a placebo through an intravenous or intramuscular injection. The exosomes contain healing substances such as growth factors and microRNAs that may promote blood vessel repair. The study includes 80 women randomly assigned to receive either the treatment or placebo, with follow-up visits extending up to 24 months to monitor long-term effects. Women in the study will undergo blood tests, vital sign checks, and imaging to assess blood vessel function and health. Researchers will measure changes in endothelial function biomarkers, blood pressure, blood counts, and edema at baseline and one week after treatment. Safety and health will be closely monitored throughout the study period, including proteinuria and uterine artery function, to evaluate the treatment's impact on vascular repair and cardiovascular risk reduction.
CONDITIONS
MSC Exosome Therapy for Post-Preeclampsia Endothelial Dysfunction
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose administered within the first or second week postpartum
Participants receive a single intravenous or intramuscular dose of mesenchymal stem cell-derived exosomes or placebo to promote endothelial repair during the early postpartum period.
1 treatment visit (in-person)
Duration - Up to 24 months
Participants are monitored for up to 24 months to assess sustained therapeutic effects and long-term cardiovascular protection after the intervention.
Multiple follow-up visits over 24 months
Total: 1 location
1
Dr. Hasan Sadikin Central General Hospital
Bandung, West Java, Indonesia, 40161
Actively Recruiting
P
Prima N Fauziah, S.Si., M.Si.
N
Nurul Azizah, S.Tr.Keb.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Akhmad Yogi Pramatirta, Johannes Mose, Jusuf S Effendi...
https://pubmed.ncbi.nlm.nih.gov/26032325