Umbilical Cord Mesenchymal Stromal Cell Secretome for Moderate Rheumatoid Arthritis (SECRETOME-RA)
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
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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South Sumatera
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Palembang, South Sumatera, Indonésia, 30126
- Dr. Mohammad Hoesin General Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
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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.
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Comparador de Placebo: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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ACR20 Response Rate
Prazo: Week 7
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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.
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Week 7
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Radiyati Umi Partan, Professor, MD, PhD, Universitas Sriwijaya
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças musculoesqueléticas
- Artrite
- Doenças articulares
- Doenças Reumáticas
- Doenças do Tecido Conjuntivo
- Doenças autoimunes
- Doenças do sistema imunológico
- Doenças da Pele e do Tecido Conjuntivo
- Artrite, Reumatóide
- Preparações farmacêuticas
- Soluções cristalóides
- Soluções isotônicas
- Soluções
- Metabolismo
- Metaboloma
- Solução salina
- Secretoma
Outros números de identificação do estudo
- RSMH-RA-UCMSC-2026
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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