A Phase 1/2 interventional study of Umbilical cord mesenchymal stem cell-derived secretome and Placebo (0.9% sodium chloride) in Sjogren's Syndrome, sponsored by Universitas Sebelas Maret Hospital. Completed at 2 sites in Indonesia. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Universitas Sebelas Maret Hospital · Phase 1/2, Interventional, and Treatment
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.
Background: Sjogren's syndrome (SS) is a systemic autoimmune disease characterised by lymphocytic infiltration of the exocrine glands, causing dry mouth and dry eyes, with possible involvement of joints, skin, lungs, kidneys and the nervous system. There is no curative therapy, and current immunosuppressive treatment carries substantial adverse effects. The secretome of mesenchymal stem cells (cytokines, growth factors, microRNAs and extracellular vesicles) has anti-inflammatory, anti-apoptotic, anti-fibrotic and immunomodulatory properties and is a candidate cell-free therapy.
Design: Two-centre, parallel-group, randomized, placebo-controlled trial at the rheumatology outpatient clinics of Universitas Sebelas Maret Hospital, Sukoharjo, and Dr. Moewardi General Hospital, Surakarta, Indonesia. Randomization used a computer-generated simple randomization sequence (no blocking) generated and held by an independent randomization sub-team not involved in participant care or assessment. Separate independent preparator and injection sub-teams prepared and administered the study products. Secretome and placebo were packaged identically. Participants, investigators and the preparator and injection sub-teams were blinded to allocation, which was disclosed only after the study had concluded.
Intervention: Participants in the experimental arm received 1.5 mL UC-MSC-derived secretome intramuscularly on days 1, 8, 15, 22, 29 and 36. Participants in the control arm received 1.5 mL 0.9% NaCl intramuscularly on the same schedule. Both arms continued standard corticosteroid and/or immunosuppressant therapy throughout. The secretome was manufactured by PT Bifarma Adiluhung, Jakarta, Indonesia, a GMP facility certified by the Indonesian Food and Drug Authority, and supplied as a sterile, antibiotic-free and preservative-free solution; the same product was used in a previous randomized trial in systemic lupus erythematosus (NCT05921058).
Assessments: ESSDAI, ESR (modified Westergren method) and hs-CRP (turbidimetric method) were assessed before treatment, on day 22 and on day 43. Adverse events were monitored through day 91.
Sample size: Calculated with OpenEpi (comparison of two independent means): minimum 28 participants (14 per group). Thirty-six patients were assessed for eligibility; 29 were randomized (15 control, 14 secretome), all received the allocated intervention and all were analysed.
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
This study's enrollment of 29 is below the median of 50 across 218 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Universitas Sebelas Maret Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Umbilical cord mesenchymal stem cell-derived secretome
Drug: Placebo (0.9% sodium chloride)
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.
Also known as: UC-MSC secretome, Mesenchymal stem cell conditioned medium
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.
Also known as: Normal saline
Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score
Time frame: Baseline (before first injection), Day 22 and Day 43
Change in erythrocyte sedimentation rate (ESR)
Time frame: Baseline, Day 22 and Day 43
Change in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, Day 22 and Day 43
Number of participants with adverse events
Time frame: From first injection through Day 91
Plan to share: Yes — De-identified individual participant data underlying the published results will be shared.
Supporting information: Study protocol, Analytic code
Time frame: Beginning at publication of the main results, with no planned end date.
Access criteria: Available from the corresponding author (ariefnurudhin@staff.uns.ac.id) upon reasonable request.
Ran from May 2024 to primary completion in Jun 2024, 1 month.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitas Sebelas Maret Hospital