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Umbilical Cord Mesenchymal Stromal Cell Secretome for Moderate Rheumatoid Arthritis (SECRETOME-RA)

13. september 2026 oppdatert av: Universitas Sriwijaya

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Indonesia
    • South Sumatera
      • Palembang, South Sumatera, Indonesia, 30126
        • Dr. Mohammad Hoesin General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • -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.

Exclusion Criteria:

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: UC-MSC Secretome + Standard csDMARD
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.
Biologisk: Umbilical Cord-Derived Mesenchymal Stromal Cell (UC-MSC) Secretome
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 komparator: Placebo + Standard csDMARD
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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ACR20 Response Rate
Tidsramme: 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.
Week 7

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universitas Sriwijaya

Samarbeidspartnere

PT Bifarma Adiluhung
Dr. Mohammad Hoesin General Hospital

Etterforskere

  • Studiestol: Radiyati Umi Partan, Professor, MD, PhD, Universitas Sriwijaya

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. februar 2026

Primær fullføring (Faktiske)

24. april 2026

Studiet fullført (Faktiske)

4. juni 2026

Datoer for studieregistrering

Først innsendt

15. juli 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

20. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. september 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RSMH-RA-UCMSC-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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