BridgeMD
New treatment option for Rheumatoid Arthritis (RA)
Official title HiSCs in the Treatment of Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT06947746
What this study is testing
What is hiSCs?
hiSCs is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people must meet all of the following 1. 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...
- people must have received csDMARD therapy for ≥3 months, with a stable dose for ≥4 weeks prior to screening;
You likely can't join if
- people 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 how well it works evaluation of the...
- History or current evidence of clinically significant cardiovascular, neuropsychiatric, renal, hepatic, immune, or endocrine disorders (including...
- people with positive test results for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (refer to...
- 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...
See the full eligibility criteria
Who can join
- people must meet all of the following 1. 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...
- people must have received csDMARD therapy for ≥3 months, with a stable dose for ≥4 weeks prior to screening;
- 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 people intolerant to...
- 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...
- people 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.
What rules you out
- people 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 how well it works 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...
- people 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;
- 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...
- 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.;
- people 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;
- people 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)...
- people with a history of hypersensitivity to any component of the study intervention or similar compounds;
- Participation in another treatment 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;
- people 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";
- people 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...
- Any other condition that is deemed by the investigator to be unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.