Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 50Years
FEMALE
ID07183384

The Effectiveness of Mesenchymal Stem Cell-Derived Exosome Therapy in Improving Endothelial Dysfunction in Postpartum Mothers With a History of Preeclampsia

Led by Universitas Padjadjaran · Updated on 2025-09-19

80

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

Universitas Padjadjaran

Lead Sponsor

D

Dr. Hasan Sadikin General Hospital, Bandung, Indonesia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

MSC Exosome Therapy for Post-Preeclampsia Endothelial Dysfunction

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postpartum women
  • Confirmed diagnosis of preeclampsia in the last pregnancy
  • Within the first or second week postpartum
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • History of chronic hypertension prior to pregnancy
  • History of major cardiovascular disease
  • Active systemic infection
  • History of endothelial injury
  • Active smoking, vaping, alcohol use, or drug addiction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

Trial Site Locations

Total: 1 location

1

Dr. Hasan Sadikin Central General Hospital

Bandung, West Java, Indonesia, 40161

Actively Recruiting

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Research Team

P

Prima N Fauziah, S.Si., M.Si.

N

Nurul Azizah, S.Tr.Keb.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial