Rheumatoid Arthritis (RA)NCT06947746
HiSCs in the Treatment of Rheumatoid Arthritis
A study testing hiSCs in people with Rheumatoid Arthritis (RA), run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- hiSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria
- 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);
- Subjects must have received csDMARD therapy for ≥3 months, with a stable dose for ≥4 weeks prior to screening;
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- Background treatment with stable-dose MTX standard therapy, biologics, or small molecule targeted drugs, either alone or in combination, is permitted;
- The following csDMARDs, either alone or in combination, are permitted as background treatment, provided the dose has been stable for ≥4 weeks prior to screening: oral or IV MTX (10-25 mg/week; for subjects intolerant to doses ≥10 mg/week, the dose should be ≥7.5 mg/week), SAS (≤3 g/day), hydroxychloroquine (≤400 mg/day), and LEF (≤20 mg/day);
- Stable-dose NSAIDs are permitted, provided the dose has remained stable for ≥2 weeks prior to screening;
- All females of childbearing potential must have a negative blood pregnancy test within 7 days prior to treatment initiation and must not be breastfeeding. Females not of childbearing potential may be exempt from the pregnancy test and contraception. All enrolled patients (regardless of gender) must use at least one highly effective method of contraception, including adequate barrier methods, throughout the study duration;
- Subjects must be in good overall health, able to ambulate independently (excluding those requiring a wheelchair, walker, or crutches);
- Willingness and ability to adhere to scheduled visits, treatment regimens, laboratory tests, and other study-related procedures.
Who cannot join
- Subjects who meet any of the following exclusion criteria will be excluded from this study：
- 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;
- Any other acute or chronic disorder leading to coagulation dysfunction that, in the investigator's judgment, may compromise patient safety and/or interfere with the evaluation of target knee outcomes;
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- Clinically significant infection within 1 month prior to the screening visit (requiring hospitalization and parenteral administration of antibiotics, antivirals, antifungals, etc., for ≥3 days) or active infection being treated during the screening period;
- Infection in the target knee within 3 months before baseline;
- Intra-articular corticosteroid or other drug injections in the target knee within 3 months before baseline;
- History of knee injury or prior knee surgery in the target knee within 1 year prior to the baseline visit;
- Serum transaminase (ALT or AST) levels ≥2 times the upper limit of normal (ULN) during screening;
- Creatinine clearance (Ccr) <45 mL/min (based on the Cockcroft-Gault formula) during screening;
- Evidence of hematopoietic dysfunction during screening:
- Hemoglobin level <9.0 g/dL or hematocrit <30%;
- White blood cell count <3.0×10⁹/L or absolute neutrophil count (ANC) <1.2×10⁹/L;
- Platelet count <100×10⁹/L;
- Abnormal 12-lead ECG findings at screening or baseline that, in the investigator's judgment, may increase the safety risk of the study intervention or affect the interpretation of study results;
- Uncontrolled hypertension with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥90 mmHg at screening/baseline;
- Body mass index (BMI) >30 kg/m² during screening;
- Contraindications to MRI, including but not limited to the presence of cardiac pacemakers, stents, artificial heart valves, etc.;
- Subjects with a current psychiatric disorder such as anxiety or depression, or a history of such disorders, and who are deemed by the investigator to be unsuitable for participation in the study;
- Subjects with a history of malignancy (except for adequately treated or excised non-metastatic basal cell or squamous cell carcinoma of the skin);
- Pregnant or breastfeeding women, women planning to become pregnant during the study, and men planning to donate sperm during the study;
- Use of high-dose corticosteroids (i.e., intravenous or intramuscular corticosteroids or oral prednisone equivalent >10 mg/day) or unstable doses (regardless of treatment for rheumatoid arthritis or other conditions) within 28 days prior to the baseline visit;
- Subjects with a history of hypersensitivity to any component of the study intervention or similar compounds;
- Participation in another interventional clinical study within 4 weeks prior to the baseline visit or within 5 half-lives of the last dose of the investigational drug at baseline;
- History of alcohol or drug abuse within 6 months prior to the start of study intervention treatment, deemed by the investigator to hinder study participation;
- Receipt of any live virus vaccination within 8 weeks prior to the baseline visit;
- Subjects classified as legally disabled according to the April 2008 version of the "Law of the People's Republic of China on the Protection of Persons with Disabilities";
- Subjects with potential health, mental, or social conditions that, in the investigator's judgment, may prevent or hinder compliance with the study protocol;
- Peripheral or central nervous system disorders that, in the investigator's judgment, may interfere with the assessment of knee pain and function, such as fibromyalgia, significant low back pain, hip pain, sciatica, lumbar disc herniation, etc.;
- Any other condition that is deemed by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai ChangZheng hospital
Shanghai, 200003
Huji Xu, 86021-81885514, huji_xu@tsinghua.edu.cn
About this study
Official title: A Single-arm Clinical Study Assessing the Safety, Tolerability, and Preliminary Efficacy of a Single Intra-Articular Injection of hiSCs for Rheumatoid Arthritis Treatment
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.
Read the detailed description
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.
In this trial, participants who have given informed consent will be screened to determine their eligibility according to the inclusion and exclusion criteria. The study intervention consists of a single injection of hiSCs, and the primary endpoint will be assessed during the 24-week follow-up visit after the cell injection.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- hiSCs
- Keywords
- Sertoli cells, Rheumatoid Arthritis (RA), intra-articular injection, hiSCs
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hiSCsBiological
hiSCs are derived from human induced pluripotent stem cells and exhibit immunomodulatory properties.
| Study group | Role | What they receive |
|---|---|---|
| hiSCs treatment | Experimental | hiSCs，human induced Sertoli-like cells Receives: Biological: hiSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs and SAEs
The incidence of TEAEs and SAEs related to the study intervention
Measured: Within 12 weeks after the injection of hiSCs
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
Measured: At 12 weeks after the injection of hiSCs
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
Measured: At 12 weeks after the injection of hiSCs
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
Measured: At 12 weeks after the injection of hiSCs
Secondary outcomes (26)
ACR20, ACR50, ACR70
The proportion of subjects who achieved ACR20, ACR50, and ACR70(American College of Rheumatology 20%/50%/70% improvement)
Measured: At Weeks 2, 4, 8, 12, and 24
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)
Measured: At Weeks 2, 4, 8, 12, and 24
SJC
Change from baseline in 66-joint swollen joint count (SJC; ACR Core Set measure; range 0-66, higher scores indicate worse disease activity)
Measured: At Weeks 2, 4, 8, 12, and 24
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)
Measured: At Weeks 2, 4, 8, 12, and 24
Patient-reported pain intensity (VAS）
Change from baseline in patient-reported pain intensity (Visual Analog Scale [VAS]; ACR Core Set measure; 0-100 mm, higher scores indicate severe pain)
Measured: At Weeks 2, 4, 8, 12, and 24
Patient-reported global disease activity (VAS)
Change from baseline in patient-reported global disease activity (VAS; ACR Core Set measure; 0-100 mm, higher scores indicate worse status)
Measured: At Weeks 2, 4, 8, 12, and 24
Physician-evaluated global disease activity (VAS)
Change from baseline in physician-evaluated global disease activity (VAS; ACR Core Set measure; 0-100 mm, higher scores indicate worse status)
Measured: At Weeks 2, 4, 8, 12, and 24
Acute-phase reactant
Change from baseline in acute-phase reactant (C-reactive protein [CRP; high-sensitivity assay; 0-10 mg/L] or erythrocyte sedimentation rate [ESR; 0-15 mm/h]; ACR Core Set measure; higher values indicate worse inflammation)
Measured: At Weeks 2, 4, 8, 12, and 24
DAS28 (CRP or ESR) score of <2.6 and <3.2
The proportion of subjects achieving a DAS28 (CRP or ESR) score of <2.6 and <3.2
Measured: At Weeks 2, 4, 8, 12, and 24
DAS28 (CRP or ESR)
The change from baseline in Disease Activity Score 28 (DAS28) using C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), with higher scores indicating greater disease activity
Measured: At Weeks 2, 4, 8, 12, and 24
SDAI score of ≤3.3
The proportion of subjects achieving Simplified Disease Activity Index (SDAI) remission (score ≤3.3; total score range: 0-86), with lower scores indicating better disease control
Measured: At Weeks 2, 4, 8, 12, and 24
SDAI
The change from baseline in Simplified Disease Activity Index (SDAI)score（total score range: 0-86), with lower scores indicating better disease control
Measured: At Weeks 2, 4, 8, 12, and 24
CDAI score of ≤2.8
The proportion of subjects achieving Clinical Disease Activity Index (CDAI) remission (score ≤ 2.8; total score range: 0-76), with lower scores indicating better disease control
Measured: At Weeks 2, 4, 8, 12, and 24
CDAI
The change from baseline in Clinical Disease Activity Index (CDAI)score (total score range: 0-76), with lower scores indicating better disease control
Measured: At Weeks 2, 4, 8, 12, and 24
VAS
The change from baseline in Visual Analog Scale (VAS) pain score (range: 0-100 mm) for the target knee, as assessed by the subject, with higher scores indicating greater symptom severity and worse physical function
Measured: At Weeks 2, 4, 8, 12, and 24
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
Measured: At Weeks 2, 4, 8, and 24
KOOS
The change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) (range: 0-100; including Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and Quality of Life subscales), as assessed by the subject, with higher scores indicating better function and fewer symptoms
Measured: At Weeks 2, 4, 8, 12, and 24
WORMS
The change from baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) (assessing ：cartilage morphology [0-6 per subregion], bone marrow lesions [0-3 per subregion], meniscal pathology [0-4 per meniscus], subchondral cysts [0-3 per subregion], osteophytes [0-7 per subregion], bone attrition [0-3 per subregion], synovitis/effusion [0-3], ligament abnormalities [0-1 per ligament], periarticular cysts [0-3], and loose bodies [0-3]), as assessed by MRI, with higher scores indicating more severe structural damage
Measured: At 12 weeks after the injection of hiSCs
MOAKS
The change from baseline in the MRI Osteoarthritis Knee Score (MOAKS) (assessing: cartilage damage [0-3 per subregion], bone marrow lesions [0-3 per subregion], osteophytes [0-3 per subregion], meniscal pathology [0-3 per region, location；0-1 per region, morphology], synovitis/effusion [0-3], ligament/tendon abnormalities [0-1 per ligament/tendon], and periarticular features [0-1]), as assessed by MRI, with higher scores indicating more severe structural damage
Measured: At 12 weeks after the injection of hiSCs
BLOKS
The change from baseline in the Boston-Leeds Osteoarthritis Knee Score (BLOKS) (assessing: cartilage morphology [0-3 per region], bone marrow lesions [0-3 per region], osteophytes [0-3 per region], meniscal pathology [0-3 per region, location；0-1 per region, morphology], synovitis/effusion [0-3], ligament abnormalities [0-1 per ligament], and periarticular features [0-1]), as assessed by MRI, with higher scores indicating more severe structural damage
Measured: At 12 weeks after the injection of hiSCs
Synovial thickness
The change from baseline in synovial thickness (mm), as assessed by MRI, with increased values indicating greater synovial inflammation
Measured: At 12 weeks after the injection of hiSCs
Synovial blood flow
The change from baseline in synovial blood flow (measured in mL/min/100g tissue), as assessed by MRI, with increased values indicating greater vascularity
Measured: At 12 weeks after the injection of hiSCs
Joint effusion volume
The change from baseline in joint effusion volume(mL), as assessed by MRI, with increased values indicating greater effusion severity
Measured: At 12 weeks after the injection of hiSCs
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
Measured: At Weeks 2, 4, 8, and 24
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
Measured: At Weeks 2, 4, 8, and 24
ROM
The change from baseline in the range of motion (ROM) for the target knee, as assessed by a goniometer, with greater improvement indicating better physical function
Measured: At Weeks 2, 4, 8, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 May 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu huji, Shanghai Changzheng Hospital
- Investigators
- Huji Xu, Ph.D, MD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947746
- Sponsor's protocol ID
- HWHY-hiSC-01
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to concerns about the security of patients' personal information
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Clinical Study Assessing the Safety, Tolerability, and Preliminary Efficacy of a Single Intra-Articular Injection of hiSCs for Rheumatoid Arthritis Treatment
- ClinicalTrials.gov ID
- NCT06947746
- Acronym / sponsor ID
- HWHY-hiSC-01
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Sertoli cells, Rheumatoid Arthritis (RA), intra-articular injection, hiSCs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
In this trial, participants who have given informed consent will be screened to determine their eligibility according to the inclusion and exclusion criteria. The study intervention consists of a single injection of hiSCs, and the primary endpoint will be assessed during the 24-week follow-up visit after the cell injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hiSCs treatment | Experimental | Biological: hiSCshiSCs，human induced Sertoli-like cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must meet all of the following inclusion criteria
- 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);
Key exclusion criteria (32 listed)
- Subjects who meet any of the following exclusion criteria will be excluded from this study：
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hiSCshiSCs are derived from human induced pluripotent stem cells and exhibit immunomodulatory properties. | Biological | hiSCs treatment |
Primary outcome
TEAEs and SAEs
Time frame: Within 12 weeks after the injection of hiSCs
The incidence of TEAEs and SAEs related to the study intervention
WOMAC
Time frame: At 12 weeks after the injection of hiSCs
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
GSUS
Time frame: At 12 weeks after the injection of hiSCs
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
PDUS
Time frame: At 12 weeks after the injection of hiSCs
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
26 secondary outcomes
ACR20, ACR50, ACR70
Time frame: At Weeks 2, 4, 8, 12, and 24
TJC
Time frame: At Weeks 2, 4, 8, 12, and 24
SJC
Time frame: At Weeks 2, 4, 8, 12, and 24
HAQ-DI
Time frame: At Weeks 2, 4, 8, 12, and 24
Patient-reported pain intensity (VAS）
Time frame: At Weeks 2, 4, 8, 12, and 24
Patient-reported global disease activity (VAS)
Time frame: At Weeks 2, 4, 8, 12, and 24
Physician-evaluated global disease activity (VAS)
Time frame: At Weeks 2, 4, 8, 12, and 24
Acute-phase reactant
Time frame: At Weeks 2, 4, 8, 12, and 24
DAS28 (CRP or ESR) score of <2.6 and <3.2
Time frame: At Weeks 2, 4, 8, 12, and 24
DAS28 (CRP or ESR)
Time frame: At Weeks 2, 4, 8, 12, and 24
SDAI score of ≤3.3
Time frame: At Weeks 2, 4, 8, 12, and 24
SDAI
Time frame: At Weeks 2, 4, 8, 12, and 24
CDAI score of ≤2.8
Time frame: At Weeks 2, 4, 8, 12, and 24
CDAI
Time frame: At Weeks 2, 4, 8, 12, and 24
VAS
Time frame: At Weeks 2, 4, 8, 12, and 24
WOMAC
Time frame: At Weeks 2, 4, 8, and 24
KOOS
Time frame: At Weeks 2, 4, 8, 12, and 24
WORMS
Time frame: At 12 weeks after the injection of hiSCs
MOAKS
Time frame: At 12 weeks after the injection of hiSCs
BLOKS
Time frame: At 12 weeks after the injection of hiSCs
Synovial thickness
Time frame: At 12 weeks after the injection of hiSCs
Synovial blood flow
Time frame: At 12 weeks after the injection of hiSCs
Joint effusion volume
Time frame: At 12 weeks after the injection of hiSCs
GSUS
Time frame: At Weeks 2, 4, 8, and 24
PDUS
Time frame: At Weeks 2, 4, 8, and 24
ROM
Time frame: At Weeks 2, 4, 8, 12, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. Due to concerns about the security of patients' personal information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huji Xu, Ph.D, MD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hiSCs in people with Rheumatoid Arthritis (RA), run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huji Xu, Ph.D, MD (86021-81885514, huji_xu@tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEAEs and SAEs (time frame: Within 12 weeks after the injection of hiSCs). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.