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

NCT07715045 | Completed Phase 2

• 1 other identifier: RSMH-RA-UCMSC-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Rheumatoid Arthritis

Keywords

UC-MSC Secretome; Randomized Controlled Trial; Immunomodulation; Biologic Therapy; ACR 20

Outcome Measures

Primary Outcomes (1)

• ACR20 Response Rate

  Percentage of participants achieving at least a 20% improvement according to the American College of Rheumatology (ACR20) response criteria after 6 weeks of treatment, assessed at Week 7.

  Week 7

Study Arms (2)

UC-MSC Secretome + Standard csDMARD

EXPERIMENTAL

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 csDMARD

PLACEBO 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)

Interventions

Placebo (Normal Saline) OTHER

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.

Placebo + Standard csDMARD

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

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.

UC-MSC Secretome + Standard csDMARD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sriwijaya: lead
• Dr. Mohammad Hoesin General Hospital: collaborator
• PT Bifarma Adiluhung: collaborator

Study Sites (1)

Dr. Mohammad Hoesin General Hospital

Palembang, South Sumatera, 30126, Indonesia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Secretome; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Metabolome; Metabolism; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Radiyati Umi Partan, Professor, MD, PhD

  Universitas Sriwijaya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned in a 1:1 ratio to receive either intramuscular umbilical cord-derived mesenchymal stromal cell (UC-MSC) secretome plus stable conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy or placebo plus stable csDMARD therapy. Participants remained in their assigned treatment group throughout the study, and efficacy and safety outcomes were compared between the two parallel groups.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: February 4, 2026
• Primary Completion: April 24, 2026
• Study Completion: June 4, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

ID (1)