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Umbilical Cord Mesenchymal Stromal Cell Secretome for Moderate Rheumatoid Arthritis: A Randomized Double-Blind Placebo-Controlled Trial

NCT07715045

CompletedPhase 2

Sponsor: Universitas Sriwijaya

Conditions: Rheumatoid Arthritis

Interventions: Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) Secretome, Placebo (Normal Saline)

Countries: Indonesia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* -Adults aged 18 to 60 years.
* Diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR Classification Criteria.
* Moderate disease activity (DAS28-CRP \>3.2 and ≤5.1).
* Receiving stable conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy for at least 3 months before enrollment.
* Stable dose of corticosteroids and/or NSAIDs for at least 4 weeks before enrollment, if applicable.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Other autoimmune rheumatic diseases or overlap syndromes.
* Active tuberculosis or other severe active infections.
* Active hepatitis B, hepatitis C, or HIV infection.
* History of malignancy.
* Severe renal impairment or severe hepatic dysfunction.
* Uncontrolled diabetes mellitus or uncontrolled cardiovascular disease.
* Pregnancy or breastfeeding.
* Known hypersensitivity to the study intervention or its components.
* Participation in another interventional clinical trial within the previous 3 months.

Locations (1)

Palembang, South Sumatera, Indonesia