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Umbilical Cord Mesenchymal Stromal Cell Secretome for Moderate Rheumatoid Arthritis: A Randomized Double-Blind Placebo-Controlled Trial
Sponsor: Universitas Sriwijaya
Summary
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by persistent synovial inflammation, progressive joint destruction, pain, and functional disability. Although conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) are the standard treatment, many patients continue to have active disease despite therapy. Umbilical cord-derived mesenchymal stromal cell (UC-MSC) secretome contains bioactive molecules with immunomodulatory and anti-inflammatory properties that may improve clinical outcomes. This randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of intramuscular UC-MSC secretome as an adjunct to standard csDMARD therapy in patients with moderate rheumatoid arthritis. Clinical response, inflammatory biomarkers, and adverse events are evaluated throughout the study.
Official title: Clinical and Biological Effects of Intramuscular Umbilical Cord-Derived Mesenchymal Stromal Cell Secretome in Patients With Moderate Rheumatoid Arthritis: A Randomized Double-Blind Placebo-Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-02-04
Completion Date
2026-06-04
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) Secretome
Umbilical cord-derived mesenchymal stromal cell (UC-MSC) secretome was administered as a 1.5 mL intramuscular injection once weekly for six consecutive weeks in addition to stable conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy.
Placebo (Normal Saline)
Placebo consisting of 1.5 mL normal saline was administered intramuscularly once weekly for six consecutive weeks in addition to stable conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy.
Locations (1)
Dr. Mohammad Hoesin General Hospital
Palembang, South Sumatera, Indonesia