Actively Recruiting
RY_SW01 Cell Injection Therapy in Systemic Sclerosis
Led by Jiangsu Renocell Biotech Company · Updated on 2024-01-18
81
Participants Needed
1
Research Sites
640 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
Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Although guidelines recommend various drugs for symptomatic treatment, there is currently no standard therapy or effective medication to slow the progression of the disease. Therefore, for patients with diffuse SSc, as defined by a skin score of 10≤mRSS≤30 points, who have been treated with at least two therapies, including steroids, immunosuppressive agents, biologics, etc., within 5 years of diagnosis, the applicant intends to develop a drug that can both modulate the immune system and counteract fibrosis. The goal is to provide long-term benefits to patients through early intervention.
CONDITIONS
Official Title
RY_SW01 Cell Injection Therapy in Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form.
- Aged between 18 and 65 years (inclusive), regardless of gender.
- Diagnosed with systemic sclerosis (SSc) based on the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria.
- Have diffuse cutaneous SSc with disease duration of 5 years or less.
- Previously treated with at least two of these therapies: corticosteroids, immunosuppressants, biologic agents, and others.
- Have a skin score between 10 and 30 points (mRSS).
You will not qualify if you...
- Forced vital capacity (FVC) predicted percentage less than 50% at screening.
- Previously diagnosed with pulmonary arterial hypertension or have high pulmonary artery pressure at screening.
- Hospitalization-required conditions within 6 months: myocardial infarction, stroke, renal crisis, severe uncontrolled hypertension (≥160/100mmHg).
- Hospitalization-required conditions within 3 months: unstable ischemic heart disease, uncontrolled arrhythmia, heart failure (NYHA III/IV), left ventricular ejection fraction less than 50%, renal insufficiency, or hypertensive crisis.
- Other autoimmune connective tissue diseases except secondary Sjögren's syndrome.
- Laboratory abnormalities: low hemoglobin (<100g/L), low white blood cell count (<3.0×10⁹/L), low neutrophils (<1.5×10⁹/L), low platelets (<100×10⁹/L), high ALT or AST (>3 times upper limit), high bilirubin (>3 times upper limit), low estimated glomerular filtration rate (<60 mL/min/1.73m2).
- Positive for HIV antibody, active syphilis, active hepatitis C, or active hepatitis B infection.
- History of severe active infections during screening.
- Received live or attenuated vaccines within 2 months before enrollment.
- Major trauma or surgery within 3 months before enrollment or planned major surgery during study.
- Plasma exchange or extracorporeal photopheresis treatment within 3 months before enrollment.
- Participation in any other clinical trials within 3 months before enrollment.
- Prior treatment with stem cell-related drugs.
- History of any malignancy within 5 years except certain treated skin cancers or cervical carcinoma in situ.
- Allergy to albumin or lack of suitable peripheral venous access.
- Smoking 5 or more cigarettes daily within 3 months prior to screening.
- Alcohol abuse defined as over 14 units per week within 3 months prior to screening.
- History of drug abuse.
- Plans for conception or unwillingness to use contraception during the trial and for 1 year after cell infusion.
- Investigator judgment deeming unsuitable for participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Rheumatology and Immunology, Nanjing Drum Tower Hospital, the Affiliated Drum Tower Hospital of Nanjing University Medical School
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
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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