Sjogren's SyndromePhase 1/2NCT07910526
Umbilical Cord Mesenchymal Stem Cell Secretome in Patients With Sjogren's Syndrome
A Phase 1/2 study testing Umbilical cord mesenchymal stem cell-derived secretome in people with Sjogren's Syndrome, run by Universitas Sebelas Maret Hospital at 2 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Umbilical cord mesenchymal stem cell-derived secretome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 May 2024to 20 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 60 years
- Sjogren's syndrome fulfilling the 2016 ACR/EULAR classification criteria
- Outpatient of the rheumatology clinic at Universitas Sebelas Maret Hospital or Dr. Moewardi General Hospital
- Willing to provide written informed consent
Who cannot join
- Pregnancy
- History of cancer
- History of allergy
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Universitas Sebelas Maret Hospital
Sukoharjo, Central Java
Dr. Moewardi General Hospital
Surakarta, Central Java, 57126
About this study
Official title: The Effect of Mesenchymal Stem Cell Secretome on Inflammation Activity and Markers in Sjogren Syndrome: A Randomized, Placebo-Controlled, Double-Blind Trial
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.
Read the detailed description
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.
- Conditions
- Sjogren's Syndrome
- Being tested
- Umbilical cord mesenchymal stem cell-derived secretome, Placebo (0.9% sodium chloride)
- Keywords
- Sjogren's syndrome, mesenchymal stem cells, secretome, umbilical cord, ESSDAI, cell-free therapy
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord mesenchymal stem cell-derived secretomeBiological
Also called UC-MSC secretome, Mesenchymal stem cell conditioned medium
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)Drug
Also called Normal saline
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.
| Study group | Role | What they receive |
|---|---|---|
| UC-MSC Secretome | Experimental | Not described Receives: Biological: Umbilical cord mesenchymal stem cell-derived secretome |
| Placebo (0.9% NaCl) | Placebo comparator | Not described Receives: Drug: Placebo (0.9% sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score
Measured: Baseline (before first injection), Day 22 and Day 43
Secondary outcomes (3)
Change in erythrocyte sedimentation rate (ESR)
Measured: Baseline, Day 22 and Day 43
Change in high-sensitivity C-reactive protein (hs-CRP)
Measured: Baseline, Day 22 and Day 43
Number of participants with adverse events
Measured: From first injection through Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 May 2024
- Primary completion1 Jun 2024
- Study completion20 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- PT Bifarma Adiluhung
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, Universitas Sebelas Maret Hospital
- Investigators
- Nurhasan Agung Prabowo, MD, Principal investigator, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910526
- Sponsor's protocol ID
- 1.093/IV/HREC/2024
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be shared.
Publications
Nurudhin A, Werdiningsih Y, Sunarso I, Marwanta S, Damayani A, Prabowo NA, Affandi A, Gazali I, Safitri AS, Sidarta BR. Umbilical cord mesenchymal stem cell-derived secretome as a potential treatment for systemic lupus erythematosus: A double-blind randomized controlled trial. Narra J. 2025 Apr;5(1):e1799. doi: 10.52225/narra.v5i1.1799. Epub 2025 Mar 3.
PubMed 40352183
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mesenchymal Stem Cell Secretome on Inflammation Activity and Markers in Sjogren Syndrome: A Randomized, Placebo-Controlled, Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07910526
- Acronym / sponsor ID
- 1.093/IV/HREC/2024
- Conditions
- Sjogren's Syndrome
- Keywords
- Sjogren's syndrome, mesenchymal stem cells, secretome, umbilical cord, ESSDAI, cell-free therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universitas Sebelas Maret HospitalUniversity, hospital or other
- Collaborators
- PT Bifarma Adiluhung
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-MSC Secretome | Experimental | Biological: Umbilical cord mesenchymal stem cell-derived secretome |
| Placebo (0.9% NaCl) | Placebo comparator | Drug: Placebo (0.9% sodium chloride) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18 to 60 years
- Sjogren's syndrome fulfilling the 2016 ACR/EULAR classification criteria
- Outpatient of the rheumatology clinic at Universitas Sebelas Maret Hospital or Dr. Moewardi General Hospital
- Willing to provide written informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- History of cancer
- History of allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord mesenchymal stem cell-derived secretomeAlso: UC-MSC secretome, Mesenchymal stem cell conditioned mediumCell-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. | Biological | UC-MSC Secretome |
| Placebo (0.9% sodium chloride)Also: Normal salineSterile 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. | Drug | Placebo (0.9% NaCl) |
Primary outcome
Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score
Time frame: Baseline (before first injection), Day 22 and Day 43
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 40352183Nurudhin A, Werdiningsih Y, Sunarso I, Marwanta S, Damayani A, Prabowo NA, Affandi A, Gazali I, Safitri AS, Sidarta BR. Umbilical cord mesenchymal stem cell-derived secretome as a potential treatment for systemic lupus erythematosus: A double-blind randomized controlled trial. Narra J. 2025 Apr;5(1):e1799. doi: 10.52225/narra.v5i1.1799. Epub 2025 Mar 3.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurhasan Agung Prabowo, MD principal investigator
Universitas Sebelas Maret
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Umbilical cord mesenchymal stem cell-derived secretome in people with Sjogren's Syndrome, run by Universitas Sebelas Maret Hospital at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score (time frame: Baseline (before first injection), Day 22 and Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.