Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06947746

HiSCs in the Treatment of Rheumatoid Arthritis

Led by Shanghai Changzheng Hospital · Updated on 2026-02-27

15

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HiSCs in the Treatment of Rheumatoid Arthritis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign the informed consent
  • Male or female aged 18-65 years (inclusive)
  • Diagnosis of rheumatoid arthritis for at least 3 months according to ACR/EULAR 2010 criteria
  • Recurrent swelling and pain in at least one knee with WOMAC pain score 4, confirmed synovial inflammation by joint ultrasound, and no significant improvement after 3 months of anti-RA treatment
  • Received csDMARD therapy for at least 3 months with stable dose for 4 weeks prior to screening
  • Permitted background treatment with stable-dose MTX, biologics, or small molecule targeted drugs alone or combined
  • Permitted csDMARDs: oral or IV MTX (10-25 mg/week; doses 7.5 mg/week if intolerant), SAS (3 g/day), hydroxychloroquine (400 mg/day), LEF (20 mg/day) with stable dose for 4 weeks prior
  • Stable-dose NSAIDs allowed with stable dose for 2 weeks prior
  • Females of childbearing potential must have negative pregnancy test within 7 days before treatment and not be breastfeeding; all participants must use effective contraception during study
  • Good overall health and able to walk independently
  • Willing and able to follow study visits, treatments, lab tests, and procedures
Not Eligible

You will not qualify if you...

  • Other immune-mediated disorders interfering with treatment or evaluation
  • Clinically significant cardiovascular, neuropsychiatric, renal, hepatic, immune, or endocrine disorders or abnormal labs that may affect safety or efficacy
  • Positive tests for HIV, HBV, HCV, or syphilis
  • Active tuberculosis or history of active TB without adequate treatment
  • Acute or chronic coagulation disorders compromising safety or knee evaluation
  • Significant infection within 1 month prior requiring hospitalization and intravenous medications, or active infection during screening
  • Infection in target knee within 3 months prior
  • Intra-articular corticosteroid or drug injections in target knee within 3 months prior
  • Knee injury or surgery in target knee within 1 year prior
  • Elevated liver enzymes (ALT or AST 2 times upper limit of normal)
  • Creatinine clearance below 45 mL/min
  • Hematopoietic dysfunction including anemia, low white blood cell or platelet counts
  • Abnormal ECG findings increasing safety risk or affecting results
  • Uncontrolled hypertension (systolic 160 mmHg or diastolic 90 mmHg)
  • Body mass index over 30 kg/m2
  • Contraindications to MRI such as pacemakers or stents
  • Current or history of psychiatric disorders unsuitable for participation
  • History of malignancy except treated non-metastatic skin cancers
  • Pregnant or breastfeeding women, or men planning sperm donation during study
  • Use of high-dose or unstable corticosteroids within 28 days prior
  • Hypersensitivity to study intervention components
  • Participation in another interventional study within 4 weeks or 5 half-lives of last drug dose
  • Recent history of alcohol or drug abuse affecting participation
  • Receipt of live virus vaccine within 8 weeks prior
  • Legally disabled individuals
  • Health, mental, or social conditions hindering study compliance
  • Peripheral or central nervous system disorders affecting knee pain assessment
  • Any other condition deemed unsuitable by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai ChangZheng hospital

Shanghai, China, 200003

Actively Recruiting

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Research Team

H

Huji Xu, Ph.D, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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