Actively Recruiting
RY_SW01 Cell Injection Therapy in Active Lupus Nephritis
Led by Jiangsu Renocell Biotech Company · Updated on 2024-01-18
60
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Renocell Biotech Company
Lead Sponsor
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsor
AI-Summary
What this Trial Is About
RY\_SW01 Cell Injection's preclinical research results have shown that the injection significantly improved urine biochemical indicators and tissue damage in two lupus nephritis animal models after MSC administration, with no occurrence of rejection and excellent safety. The mechanism of action of RY\_SW01 Cell Injection is relatively clear, demonstrating favorable therapeutic effects in preclinical animal models. Compared to existing conventional therapies, it has the advantages of "convenient treatment and sustained efficacy." It may help reduce the variety and quantity of drugs administered to patients and the various side effects associated with drug treatment. In some cases, it may even lead to the discontinuation of immunosuppressive drugs, reducing mortality and disability rates while improving the quality of life for patients. Its unique advantages have the potential to fundamentally change the current clinical treatment landscape and offer promising prospects for clinical application.
CONDITIONS
Official Title
RY_SW01 Cell Injection Therapy in Active Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign an informed consent form
- Male or female aged 18 to 65 years
- Medical history meeting at least 4 of the 11 SLE classification criteria with a SLEDAI score of 6 or higher
- Previously received induction therapy with steroids and immunosuppressants or biologics and showed intolerance or lack of response
- Confirmed diagnosis of class III or IV lupus nephritis, possibly combined with class V
- Laboratory test showing urinary protein-to-creatinine ratio greater than 1000 mg/g or 1.0
- No plans for pregnancy during the trial and for at least 1 year after injection; agree to use effective contraception and no plans for sperm or egg donation
You will not qualify if you...
- Severe liver dysfunction with bilirubin or liver enzymes more than twice the upper limit of normal
- Severe kidney dysfunction with eGFR below 30 mL/min/1.73m² or serum creatinine over 265.2 µmol/L
- Kidney biopsy showing 50% or more glomerulosclerosis
- Low blood cell counts including white blood cells, hemoglobin, platelets, or neutrophils below specified thresholds
- Severe uncontrolled cardiovascular, neurological, pulmonary, liver, endocrine, or gastrointestinal diseases including severe hypertension, heart failure, recent heart attack or stroke, severe pulmonary hypertension, or serious arrhythmias
- History of IgA deficiency
- Other autoimmune diseases except secondary Sjögren's syndrome
- Recent live vaccine administration within 12 weeks or planned during trial
- Recent plasmapheresis, immunoadsorption, or intravenous immunoglobulin therapy within specified timeframes
- Use of other investigational drugs within 12 weeks
- Positive tests for HIV, active syphilis, active hepatitis C, or active hepatitis B with high viral load
- History of severe or recurrent infections during screening
- Malignant tumors within past 5 years except treated basal cell carcinoma
- Major surgery within past 12 weeks or planned during trial posing unacceptable risk
- Allergies or intolerance to allogeneic mesenchymal stem cells, corticosteroids, or lack of peripheral venous access
- Pregnant or lactating women
- Recent smoking, alcohol misuse, or drug abuse as defined by specified criteria
- Investigator judgment of unsuitability for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
the Affiliated Drum Tower Hospital, Medical School, Nanjing University
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
N
Ning Wei
CONTACT
J
Jing Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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