Rheumatoid ArthritisPhase 2SECRETOME-RANCT07715045
Umbilical Cord Mesenchymal Stromal Cell Secretome for Moderate Rheumatoid Arthritis
A Phase 2 study testing Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) Secretome in people with Rheumatoid Arthritis, run by Universitas Sriwijaya at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) Secretome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Feb 2026to 4 Jun 2026
- Phase
- Phase 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -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.
Who cannot join
- 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.
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- Pregnancy or breastfeeding.
- Known hypersensitivity to the study intervention or its components.
- Participation in another interventional clinical trial within the previous 3 months.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Mohammad Hoesin General Hospital
Palembang, South Sumatera, 30126
About this study
Official title: Clinical and Biological Effects of Intramuscular Umbilical Cord-Derived Mesenchymal Stromal Cell Secretome in Patients With Moderate Rheumatoid Arthritis: A Randomized Double-Blind Placebo-Controlled Trial
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.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by persistent synovial inflammation, progressive cartilage destruction, bone erosion, and functional disability. Although conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) remain the standard treatment, a substantial proportion of patients continue to experience active disease, highlighting the need for adjunctive therapeutic strategies.
Umbilical cord-derived mesenchymal stromal cell (UC-MSC) secretome is a cell-free biological product containing cytokines, growth factors, extracellular vesicles, and other bioactive molecules with immunomodulatory, anti-inflammatory, and regenerative properties. Compared with live-cell therapy, secretome-based treatment may offer advantages including lower immunogenicity, easier storage and transportation, and standardized manufacturing.
This prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of intramuscular UC-MSC secretome administered in combination with stable csDMARD therapy in patients with moderate rheumatoid arthritis. Participants were randomly assigned to receive either UC-MSC secretome or placebo in addition to standard treatment. The intervention consisted of six weekly intramuscular injections, followed by protocol-defined clinical and safety follow-up.
The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% improvement response (ACR20). Key secondary endpoints included ACR50 and ACR70 response rates, changes in inflammatory biomarkers (including TNF-α, IL-6, and TGF-β), disease activity, patient-reported outcomes, and treatment safety.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) Secretome, Placebo (Normal Saline)
- Keywords
- UC-MSC Secretome, Randomized Controlled Trial, Immunomodulation, Biologic Therapy, ACR 20
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) SecretomeBiological
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start4 Feb 2026
- Primary completion24 Apr 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Mohammad Hoesin General Hospital, PT Bifarma Adiluhung
- Responsible party
- Sponsor
- Investigators
- Radiyati Umi Partan, Professor, MD, PhD, Study chair, Universitas Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715045
- Sponsor's protocol ID
- RSMH-RA-UCMSC-2026
- Acronym
- SECRETOME-RA
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Only aggregated and de-identified study results will be reported in scientific publications. Individual participant data will be kept confidential in accordance with the informed consent, ethical approval, and applicable data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Effects of Intramuscular Umbilical Cord-Derived Mesenchymal Stromal Cell Secretome in Patients With Moderate Rheumatoid Arthritis: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07715045
- Acronym / sponsor ID
- SECRETOME-RA / RSMH-RA-UCMSC-2026
- Conditions
- Rheumatoid Arthritis
- Keywords
- UC-MSC Secretome, Randomized Controlled Trial, Immunomodulation, Biologic Therapy, ACR 20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Collaborators
- Dr. Mohammad Hoesin General Hospital, PT Bifarma Adiluhung
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 20 Jul 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.
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.
Detailed description
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by persistent synovial inflammation, progressive cartilage destruction, bone erosion, and functional disability. Although conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) remain the standard treatment, a substantial proportion of patients continue to experience active disease, highlighting the need for adjunctive therapeutic strategies.
Umbilical cord-derived mesenchymal stromal cell (UC-MSC) secretome is a cell-free biological product containing cytokines, growth factors, extracellular vesicles, and other bioactive molecules with immunomodulatory, anti-inflammatory, and regenerative properties. Compared with live-cell therapy, secretome-based treatment may offer advantages including lower immunogenicity, easier storage and transportation, and standardized manufacturing.
This prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of intramuscular UC-MSC secretome administered in combination with stable csDMARD therapy in patients with moderate rheumatoid arthritis. Participants were randomly assigned to receive either UC-MSC secretome or placebo in addition to standard treatment. The intervention consisted of six weekly intramuscular injections, followed by protocol-defined clinical and safety follow-up.
The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% improvement response (ACR20). Key secondary endpoints included ACR50 and ACR70 response rates, changes in inflammatory biomarkers (including TNF-α, IL-6, and TGF-β), disease activity, patient-reported outcomes, and treatment safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| UC-MSC Secretome + Standard csDMARD | Experimental | Biological: Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) SecretomeParticipants 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. |
| Placebo + Standard csDMARD | Placebo comparator | Other: Placebo (Normal Saline)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- -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.
Key exclusion criteria (9 listed)
- 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.
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-Derived Mesenchymal Stromal Cell (UC-MSC) SecretomeUmbilical 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. | Biological | UC-MSC Secretome + Standard csDMARD |
| Placebo (Normal Saline)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. | Other | Placebo + Standard csDMARD |
Primary outcome
ACR20 Response Rate
Time frame: Week 7
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.
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 16 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Only aggregated and de-identified study results will be reported in scientific publications. Individual participant data will be kept confidential in accordance with the informed consent, ethical approval, and applicable data protection requirements.
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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.
Radiyati Umi Partan, Professor, MD, PhD study chair
Universitas Sriwijaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) Secretome in people with Rheumatoid Arthritis, run by Universitas Sriwijaya at 1 site 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 6 inclusion and 9 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
ACR20 Response Rate (time frame: Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.