HiSCs in the Treatment of Rheumatoid Arthritis
ConditionRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Changzheng Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Voluntarily sign the informed consent;
Male or female aged 18-65 years (inclusive) at the time of signing the informed consent;
Diagnosis of RA for ≥3 months according to the ACR/EULAR 2010 Rheumatoid Arthritis Classification Criteria at the screening visit;
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);
Disqualifiers
Presence of other immune-mediated disorders at the baseline visit that may interfere with the administration or efficacy evaluation of the study intervention;
History or current evidence of clinically significant cardiovascular, neuropsychiatric, renal, hepatic, immune, or endocrine disorders (including uncontrolled diabetes or thyroid disease), abnormal laboratory findings, or conditions requiring medications prohibited by the study protocol. "Clinically significant" refers to conditions that, in the investigator's judgment, may jeopardize subject safety or impact efficacy or safety analyses if the disease/condition exacerbates during the study;
Subjects with positive test results for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (refer to laboratory tests for details);
Evidence of active tuberculosis (TB) or a history of active TB without adequate documented treatment;
Trial design
Design model
Single group
Treatments tested in this trial
hiSCs
Biological/VaccinehiSCs are derived from human induced pluripotent stem cells and exhibit immunomodulatory properties.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: hiSCs treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
TEAEs and SAEs
The incidence of TEAEs and SAEs related to the study intervention
Time frame
Within 12 weeks after the injection of hiSCs2
WOMAC
The change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (range: 0-240 cm; including pain, stiffness, and physical function subscales) for the target knee, as assessed by the subject, with higher scores indicating greater symptom severity and worse physical function
Time frame
At 12 weeks after the injection of hiSCs3
GSUS
The change from baseline in Gray-scale ultrasound (GSUS) (range: 0-12; including suprapatellar, medial, lateral, and posterior planes) for the target knee, as assessed by musculoskeletal ultrasound, with higher scores indicating more severe synovitis
Time frame
At 12 weeks after the injection of hiSCs4
PDUS
The change from baseline in Power Doppler Ultrasound Synovitis (PDUS) score (range: 0-15; including suprapatellar, infrapatellar, medial, lateral, and posterior compartments) for the target knee, as assessed by power Doppler ultrasound, with higher scores indicating more severe synovitis
Time frame
At 12 weeks after the injection of hiSCsSecondary outcomes
1
ACR20, ACR50, ACR70
The proportion of subjects who achieved ACR20, ACR50, and ACR70(American College of Rheumatology 20%/50%/70% improvement)
Time frame
At Weeks 2, 4, 8, 12, and 242
TJC
Change from baseline in 68-joint tender joint count (TJC; American College of Rheumatology \[ACR\] Core Set measure; range 0-68, higher scores indicate worse disease activity)
Time frame
At Weeks 2, 4, 8, 12, and 243
SJC
Change from baseline in 66-joint swollen joint count (SJC; ACR Core Set measure; range 0-66, higher scores indicate worse disease activity)
Time frame
At Weeks 2, 4, 8, 12, and 244
HAQ-DI
Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI; ACR Core Set measure; range 0-3, higher scores indicate worse functional status)
Time frame
At Weeks 2, 4, 8, 12, and 24Other outcomes
1
Cytomorphology
The change from baseline in synovial fluid morphological characteristics (%) in the target knee, as assessed by pathological microscopy
Time frame
At 12 weeks after the injection of hiSCs2
Total protein
The change from baseline in synovial fluidtotal protein concentration (g/L) in the target knee
Time frame
At 12 weeks after the injection of hiSCs3
Cytokine response
The change from baseline in synovial fluid cytokine response（large panel of cytokines characteristic of the inflammatory response, including TNFα, IL-6, IL-8, IL-10, γ-IFN, IL-17A, SERPINA3, TGFβ1, IGFBP7, MMP-3, VEGF) in the target knee
Time frame
At 12 weeks after the injection of hiSCs4
RF
The change from baseline in synovial fluidrheumatoid factor (RF) concentration (IU/ML) in the target knee
Time frame
At 12 weeks after the injection of hiSCsSponsors and contacts
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Source ClinicalTrials.gov