Trial Parameters
Brief Summary
This trial is a single-center, single-arm exploratory clinical study aimed at assessing the safety, tolerability, and preliminary efficacy of a single intra-articular injection of hiSCs for the treatment of rheumatoid arthritis.
Eligibility Criteria
Inclusion Criteria: Subjects must meet all of the following inclusion criteria 1. Voluntarily sign the informed consent; 2. Male or female aged 18-65 years (inclusive) at the time of signing the informed consent; 3. Diagnosis of RA for ≥3 months according to the ACR/EULAR 2010 Rheumatoid Arthritis Classification Criteria at the screening visit; 4. At the screening visit, presence of recurrent swelling and pain in at least one knee, with a WOMAC pain score ≥4, synovial inflammation confirmed by joint ultrasound, and no significant improvement following 3 months of anti-RA treatment (including prior use of MTX standard therapy, biologics, or small molecule targeted drugs); 5. Subjects must have received csDMARD therapy for ≥3 months, with a stable dose for ≥4 weeks prior to screening; 6. Background treatment with stable-dose MTX standard therapy, biologics, or small molecule targeted drugs, either alone or in combination, is permitted; 7. The following csDMARDs, either alone or in combin