MSC Exosome Therapy for Post-Preeclampsia Endothelial Dysfunction

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

July 1, 2026

Study Completion Date

September 1, 2026

Conditions
PreeclampsiaPostpartumEndothelial InjuryExosome MultiomicsCell Therapy
Interventions
BIOLOGICAL

Mesenchymal Stem Cell-Derived Exosomes

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.

OTHER

Placebo (Sterile Saline Solution)

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.

Trial Locations (1)

40161

RECRUITING

Dr. Hasan Sadikin Central General Hospital, Bandung

All Listed Sponsors
collaborator

Dr. Hasan Sadikin General Hospital, Bandung, Indonesia

UNKNOWN

collaborator

Dr Cipto Mangunkusumo General Hospital

OTHER

collaborator

Dr. Sardjito Hospital, Yogyakarta

UNKNOWN

lead

Universitas Padjadjaran

OTHER