Umbilical Cord Mesenchymal Stromal Cell Secretome for Moderate Rheumatoid Arthritis: A Randomized Double-Blind Placebo-Controlled Trial (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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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South Sumatera
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Palembang, South Sumatera, 인도네시아, 30126
- Dr. Mohammad Hoesin General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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ACR20 Response Rate
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: Radiyati Umi Partan, Professor, MD, PhD, Universitas Sriwijaya
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RSMH-RA-UCMSC-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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류마티스 관절염에 대한 임상 시험
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Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아