MSC Exosome Therapy for Post-Preeclampsia Endothelial Dysfunction

NCT07183384 | Recruiting Phase 1 DMC

• 1 other identifier: OBGY-202508.01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

\--- 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.

Conditions

Preeclampsia; Postpartum; Endothelial Injury; Exosome Multiomics; Cell Therapy

Keywords

Preeclampsia; Postpartum; Stem Cell; Exosome; Cell Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Endothelial Function Biomarker (miR-126-3p)

  Measure: Change in miR-126-3p expression levels from baseline to 1 week post-intervention. Method: RT-PCR analysis of blood samples. Unit: Fold change (relative expression). Scale Description: Continuous variable measured as fold change relative to baseline. Higher values indicate improved endothelial function. Normal range: 0.8-1.2 fold change. Values \<0.8 indicate dysfunction.

  Baseline and 1 week post-intervention

Secondary Outcomes (17)

• Systolic Blood Pressure

  Baseline, first week, and 1 week post-intervention

• Diastolic Blood Pressure

  Baseline, first week, and 1 week post-intervention

• Hemoglobin Level

  Baseline and 1 week post-intervention

• Hematocrit Level

  Baseline and 1 week post-intervention

• Leukocyte Count

  Baseline and 1 week post-intervention

Other Outcomes (1)

• Number of participants with clinically significant abnormal laboratory test results

  Baseline to 7 days after last dose of exosomes.

Study Arms (2)

MSC-derived Exosome Therapy

EXPERIMENTAL

Participants receive Intravenous or Intramuscular MSC-derived exosomes.

Biological: Mesenchymal Stem Cell-Derived Exosomes

Saline/Placebo

PLACEBO COMPARATOR

Participants receive Intravenous or Intramuscular sterile saline solution

Other: Placebo (Sterile Saline Solution)

Interventions

Mesenchymal Stem Cell-Derived Exosomes BIOLOGICAL

Mesenchymal stem cell-derived exosomes isolated from adipose-derived stem cells (ASC). The exosomes contain bioactive molecules including microRNAs (particularly miR-126-3p), proteins, and lipids that promote endothelial repair and regeneration. The product is manufactured under GMP conditions and administered as a single Intravenous or Intramuscular infusion.

Also known as: MSC-Exos, Fetal stem cell exosomes

MSC-derived Exosome Therapy

Placebo (Sterile Saline Solution) OTHER

Sterile saline solution (0.9% sodium chloride) administered Intravenous or Intramuscular as placebo control. The volume and administration method are identical to the active treatment to maintain blinding.

Also known as: Normal saline, 0.9% sodium chloride

Saline/Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only biologically female participants who are postpartum mothers with a history of preeclampsia are eligible to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postpartum
• Confirmed diagnosis of preeclampsia in the last pregnancy
• Postpartum period of first week and second week
• Able to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• Dr. Hasan Sadikin General Hospital, Bandung, Indonesia: collaborator
• Dr Cipto Mangunkusumo General Hospital: collaborator
• Dr. Sardjito Hospital, Yogyakarta: collaborator

Study Sites (1)

Dr. Hasan Sadikin Central General Hospital

Bandung, West Java, 40161, Indonesia

RECRUITING

Related Publications (3)

• Vioretti, R., Khairani, A. F., Fauziah, P. N., & Hilmanto, D. (2018). An evaluation of soyghurt potential on tumor necrosis factor-α and soluble endoglin levels in preclampsia maternal serum-induced placental trophoblast cell in vitro. International Food Research Journal, 25(4), 1397-1402.

  BACKGROUND

• Gurnadi, J. I., Mose, J. C., Handono, B., Fauziah, P. N., & Pramatirta, A. Y. (2015). Correlation between fms-Like tyrosine kinase-1 (sFlt-1) cell-free messenger RNA expression and fms-Like tyrosine kinase-1 (sFlt-1) protein level in severe preeclampsia and normal pregnancy. International Journal of Integrated Health Sciences, 3(2), 66-71.

  BACKGROUND

• Pramatirta AY, Mose J, Effendi JS, Krisnadi SR, Anwar AD, Fauziah PN, Gurnadi JI, Rihibiha DD. Correlation between cell-free mRNA expressions and PLGF protein level in severe preeclampsia. BMC Res Notes. 2015 Jun 2;8:208. doi: 10.1186/s13104-015-1186-9.

  PMID: 26032325 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Akhmad Y Pramatirta, M.D., Ph.D

  Dr. Hasan Sadikin Central General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+62 85721368609; primanandafauziah@gmail.com

Nurul Azizah, S.Tr.Keb.

CONTACT

+62 81312971480; nurul19012@mail.unpad.ac.id

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled clinical trial with parallel group design. Participants will be randomized 1:1 to receive either MSC-derived exosomes or placebo (sterile saline solution). Both groups will be followed for the same duration with identical assessment schedules.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 19, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual participant data and supporting documents will be available beginning 9 months and ending 60 months following article publication. This timeframe allows for completion of primary analyses and preparation of data for sharing while ensuring long-term availability for secondary research and meta-analyses.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal for secondary research purposes including individual participant data meta-analyses. Requestors must have approval from an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and execute a data sharing agreement with Dr. Hasan Sadikin Central General Hospital. Proposals should be directed to akhmad.yogi@unpad.ac.id. Access will be granted for analyses that align with the study's scientific objectives and ethical considerations

Locations

ID (1)