Umbilical Cord Mesenchymal Stromal Cell Secretome for Moderate Rheumatoid Arthritis: A Randomized… (NCT07715045) | Clinical Trial Compass
CompletedPhase 2
Umbilical Cord Mesenchymal Stromal Cell Secretome for Moderate Rheumatoid Arthritis: A Randomized Double-Blind Placebo-Controlled Trial
Indonesia40 participantsStarted 2026-02-04
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.