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Umbilical Cord Mesenchymal Stem Cell Secretome in Patients With Sjogren's Syndrome
Sponsor: Universitas Sebelas Maret Hospital
Summary
This randomized, placebo-controlled, double-blind trial evaluated the safety and efficacy of umbilical cord mesenchymal stem cell (UC-MSC) secretome, given as an add-on to standard therapy, in women with Sjogren's syndrome. Twenty-nine participants were randomly assigned to receive six intramuscular injections of either UC-MSC secretome or 0.9% sodium chloride (placebo) over five weeks, while continuing their usual corticosteroid and/or immunosuppressant treatment. The main outcome was the change in disease activity measured by the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI). Secondary outcomes were the inflammatory markers erythrocyte sedimentation rate (ESR) and high-sensitivity C-reactive protein (hs-CRP), and adverse events.
Official title: The Effect of Mesenchymal Stem Cell Secretome on Inflammation Activity and Markers in Sjogren Syndrome: A Randomized, Placebo-Controlled, Double-Blind Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2024-05-01
Completion Date
2026-10-20
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Umbilical cord mesenchymal stem cell-derived secretome
Cell-free secretome (conditioned medium) derived from human umbilical cord mesenchymal stem cells (UC-MSC), manufactured by PT Bifarma Adiluhung, Jakarta, Indonesia, in a GMP facility certified by the Indonesian Food and Drug Authority (BPOM). Supplied as a sterile, antibiotic-free and preservative-free solution. Dose: 1.5 mL by intramuscular injection once weekly for 6 doses (days 1, 8, 15, 22, 29 and 36), given in addition to the participant's standard corticosteroid and/or immunosuppressant therapy. Same secretome product as used in NCT05921058 (systemic lupus erythematosus). Sterile 0.9% sodium chloride solution, 1.5 mL by intramuscular injection once weekly for 6 doses (days 1, 8, 15, 22, 29 and 36), given in addition to the participant's standard corticosteroid and/or immunosuppressant therapy. Packaged identically to the secretome so that participants and investigators could not tell the two apart.
Placebo (0.9% sodium chloride)
Sterile 0.9% sodium chloride solution, 1.5 mL by intramuscular injection once weekly for 6 doses (days 1, 8, 15, 22, 29 and 36), given in addition to the participant's standard corticosteroid and/or immunosuppressant therapy. Packaged identically to the secretome so that participants and investigators could not tell the two apart.
Locations (2)
Universitas Sebelas Maret Hospital
Sukoharjo, Central Java, Indonesia
Dr. Moewardi General Hospital
Surakarta, Central Java, Indonesia