Rheumatoid Arthritis
Conditions
Interventions
Trial group1:Single intravenous injection, 5 × 10^7 cells per person per dose
Trial group 2:Single intravenous injection, 1.5 × 10^8 cells per person per dose
Trial group 3:Single intravenous injection, 2.5 × 10^8 cells per person per dose
Control group:Single intravenous injection, placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, no gender restrictions 2. Body Mass Index (BMI) >= 18 kg/m^2 and <= 30 kg/m^2 3. Diagnosed with rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria 4. After at least 3 months of treatment, the response remains inadequate or intolerable, and the disease persists at moderate to high disease activity levels 5. Positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) antibody 6. Clinical parameters stable and no significant changes in general physical condition from screening initiation to dosing 7. All participants and their partners have no plans for pregnancy from screening through 6 months post-dosing and agree to use effective non-pharmacological contraception during the trial 8. Willingness to adhere to study protocols and ensure good compliance throughout the study period 9. Voluntary participation in this clinical trial and signing of the informed consent form
Exclusion criteria
Exclusion criteria: 1. History of severe allergies; individuals with a history of allergic reactions to any component, including the investigational product and excipients 2. Participants diagnosed with ACR functional classification IV rheumatoid arthritis 3. Individuals with a tendency toward spontaneous bleeding or delayed blood coagulation (e.g., hemophilia, purpura, thrombocytopenia) 4. Individuals with peptic ulcer disease, active trauma, or postpartum hemorrhage. 5. Individuals who received treatment with the following biologics or targeted inhibitors within the specified periods prior to study initiation: Infliximab: 8 weeks; Etanercept: 4 weeks; Adalimumab and Secukinumab: 8 weeks; Abatacept, tocilizumab, and golimumab: 8 weeks; Rituximab: 24 weeks; Tofacitinib, baricitinib, and upadacitinib: 4 weeks 6. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) for symptoms and signs of rheumatoid arthritis within 7 days prior to screening, except for those with stable dosing for 14 days prior to screening 7. History of any severe infection or recent serious infection within 3 months prior to screening (any requiring hospitalization and/or intravenous antibiotic therapy) 8. Active pulmonary tuberculosis, latent tuberculosis infection, or pulmonary infection 9. Clinically diagnosed severe cardiovascular, neurological/psychiatric, hepatic, renal, or endocrine disorders (including uncontrolled diabetes or thyroid disease), or hematologic abnormalities deemed by the investigator to potentially interfere with participant compliance or study assessments 10. History of cerebrovascular accident (stroke) within 1 year prior to screening 11. Clinically significant cardiac disease (New York Heart Association [NYHA] functional class III or IV) 12. Participants with congenital immunodeficiency. 13. Positive screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponemal antibody (Tp-Ab), or human immunodeficiency virus antibody (HIV-Ab). 14. Screening laboratory results meeting any of the following criteria: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin (TBIL) > 2 times ULN; Serum creatinine (Scr) > 1.5 times ULN; Estimated glomerular filtration rate (eGFR) <= 60 mL/min/1.73m² [calculated using the CKD-EPI (EPI-(Scr)) formula]; Hemoglobin <= 70 g/L 15. Previous receipt of stem cell therapy, solid organ transplantation, or hematopoietic stem cell transplantation 16. Participation in other clinical trials and receipt of other investigational drug treatments within 3 months prior to screening 17. Females who are pregnant or breastfeeding at the time of screening 18. History of malignant tumors 19. Other patients deemed unsuitable for this trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| American College of Rheumatology 20/50/70 Response Criteria?;28-joint Disease Activity Score based on C-reactive protein; Health Assessment Questionnaire;Simplified disease activity index;Clinical disease activity index;Visual analogue scale;Physician global assesssment of disease activity;Patient global assessment of disease activity; | — |
Countries
China
Contacts
Public ContactLi Zhenguo
Peking University People's Hospital
Outcome results
None listed