RY_SW01 Cell Injection Therapy in Systemic Sclerosis
Recruiting
Phase 1Phase 2Interventional Study
Systemic Sclerosis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
81 (estimated)
Sponsor
Jiangsu Renocell Biotech Company · Industry
Who this trial is looking for
This trial is looking for people with systemic sclerosis who have already tried multiple treatments. Participants will receive a new therapy that aims to help their immune system and reduce fibrosis.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with systemic sclerosis.
I have diffuse cutaneous systemic sclerosis and my disease has lasted 5 years or less.
I have tried at least two different treatments for my condition.
I have a skin score between 10 and 30.
You may not be able to join if
I have a lung function test showing my capacity is less than 50%.
I have been diagnosed with pulmonary arterial hypertension.
I have had major health issues like a heart attack or stroke in the past 6 months.
I have a serious infection or long-term illness that might affect my participation.
I have received live vaccines in the past 2 months.
I have a history of cancer in the past 5 years, except for some skin cancers.
I am currently using drugs or have abused drugs in the past 12 months.
I have plans to have a baby or am not willing to use birth control during the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 medicatio…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Voluntarily sign the informed consent form.
2. Aged between 18 and 65 years (inclusive), regardless of gender.
3. Diagnosed with systemic sclerosis (SSc) based on the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for SSc.
4. S…
Inclusion Criteria:
1. Voluntarily sign the informed consent form.
2. Aged between 18 and 65 years (inclusive), regardless of gender.
3. Diagnosed with systemic sclerosis (SSc) based on the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for SSc.
4. Screened as diffuse cutaneous SSc patients with a disease duration of ≤5 years (disease onset defined as the time of the initial diagnosis of SSc).
5. Previously treated with at least two of the following therapies: corticosteroids, immunosuppressants, biologic agents, and others, and have a skin score of 10≤mRSS≤30 points.
Exclusion Criteria:
1. At screening, subjects with a forced vital capacity (FVC) predicted percentage \<50%.
2. Previously diagnosed with pulmonary arterial hypertension or, at rest, had a mean pulmonary arterial pressure \>25mmHg measured by right heart catheterization or had a systolic pulmonary artery pressure \>45mmHg measured by echocardiography at screening.
3. Presence of clinical symptoms requiring hospitalization for one of the following conditions at screening, whether newly occurring or worsening of pre-existing symptoms within 6 months: myocardial infarction, stroke, renal crisis, severe uncontrolled hypertension (≥160/100mmHg); or within 3 months: unstable ischemic heart disease, uncontrolled arrhythmia, heart failure (New York Heart Association III/IV stage), left ventricular ejection fraction \<50% as indicated by echocardiography, renal insufficiency, or hypertensive crisis as judged by the investigator.
4. Concurrent autoimmune connective tissue diseases other than systemic sclerosis, with the exception of patients with secondary Sjögren's syndrome.
5. Presence of any of the following laboratory abnormalities at screening:
1. Hematology abnormalities: Hemoglobin \<100g/L; White blood cell count \<3.0×109/L; Neutrophil absolute count \<1.5×109/L; Platelet count \<100×109/L.
2. Hepatic function abnormalities: ALT or AST \>3 times the upper limit of normal (ULN); Total bilirubin \>3 times ULN.
3. Renal function abnormalities: Estimated glomerular filtration rate (eGFR) \<60mL/min/1.73m2 or any clinically significant laboratory abnormalities that may affect the interpretation of study data or the subject's participation in the study as determined by the investigator.
6. Positive testing for human immunodeficiency virus (HIV) antibody, active syphilis, active hepatitis C (positive HCV antibodies and positive HCV-RNA), HBsAg positive and HBV-DNA positive at screening; history of severe active bacterial, viral, fungal, parasitic, or other infections during the screening period.
7. Receipt of live vaccines/attenuated vaccines within 2 months prior to enrollment.
8. Occurrence of any of the following within 3 months prior to enrollment: a. Major trauma or major surgery (including joint surgery) or anticipated major surgery during the study, which the investigator believes would pose an unacceptable risk to the subject. b. Plasma exchange or extracorporeal photopheresis treatment. c. Participation in any other clinical trials.
9. Prior treatment with stem cell-related drugs.
10. History of any malignancy within the past 5 years prior to enrollment, except for adequately treated or excised basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical carcinoma.
11. Intolerance or contraindication to the study treatment, including any of the following: a. Allergy to albumin contained in the investigational product excipient. b. Lack of suitable peripheral venous access.
12. History of smoking, alcohol abuse, or drug abuse within the past 12 months or during the screening period:
1. Smoking defined as an average daily consumption of ≥5 cigarettes within the 3 months prior to screening.
2. Alcohol abuse defined as consuming more than 14 units of alcohol per week (1 unit of alcohol = 350ml of beer, or 45ml of spirits, or 150ml of wine) within the 3 months prior to screening.
3. Drug abuse defined as having a history of drug abuse.
13. Plans for conception during the trial period until at least 1 year after cell infusion, unwillingness to use effective contraceptive measures with their partners, or plans for sperm or egg donation.
14. Deemed unsuitable for participation in the study by the investigator.
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