Umbilical Cord Mesenchymal Stromal Cell Secretome for Moderate Rheumatoid Arthritis: A Randomized Double-Blind Placebo-Controlled Trial | NCT07715045

NCT07715045

Overview

NCT ID: NCT07715045
Lead Sponsor: Universitas SriwijayaOTHER
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
Brief 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.
Conditions

Status and Timeline

Status: Completed
Last Update Posted: Jul 20, 2026Actual
Start Date: Feb 4, 2026Actual
Primary Completion Date: Apr 24, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 40Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: No data available
Locations: Dr. Mohammad Hoesin General Hospital

Similar Studies

Masking Description

Participants, care providers administering the study intervention, investigators responsible for clinical management, and outcome assessors were blinded to treatment allocation. UC-MSC secretome and placebo were prepared in identical syringes with identical appearance, volume, and labeling. Randomization codes were generated by an independent statistician and maintained in sealed allocation records until completion of data collection, unless emergency unblinding was required for participant safety. Laboratory personnel performing biomarker analyses remained blinded to treatment allocation until database lock.

Participant Group/Arms

UC-MSC Secretome + Standard csDMARDExperimental

Participants received 1.5 mL intramuscular umbilical cord-derived mesenchymal stromal cell (UC-MSC) secretome once weekly for six consecutive weeks in addition to stable conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy. Clinical outcomes and biomarkers were evaluated throughout the study and during follow-up.

Biological: Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) Secretome

Placebo + Standard csDMARDPlacebo Comparator

Participants received 1.5 mL intramuscular placebo (normal saline) once weekly for six consecutive weeks in addition to stable conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy. Clinical outcomes and biomarkers were evaluated throughout the study and during follow-up.

Other: Placebo (Normal Saline)