Systemic sclerosis
Conditions
Interventions
Single-dose group:89Zr-Oxine-RY_SW01 Cell Injection 2.0 x 10^6 cells/kg treatment
Sponsors
The First Hospital of Suzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary signing of informed consent; 2. Age 18-65 years old (including the threshold), male and female; 3. Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for systemic sclerosis (SSc); 4. Patients diagnosed with diffuse scleroderma after previous treatment with two or more modalities such as hormones, immunosuppressants, and biologics.
Exclusion criteria
Exclusion criteria: 1.Percentage of patient's predicted lung function FVC (forceful lung volume) 45 mmHg measured by echocardiography at screening; 3. The following conditions existed before the screening: (1) myocardial infarction, stroke, renal crisis, severe intestinal disease, severe hypertension (>=160/100mmHg) uncontrolled patients with the onset or exacerbation of clinical symptoms within 6 months; (2) unstable ischemic heart disease, uncontrolled arrhythmia, cardiac arrhythmia, cardiac tachyarrhythmia, and cardiac tachycardia (>=160/100mmHg) uncontrolled patients with the onset or aggravation of clinical symptoms within 3 months. controlled arrhythmia, heart failure, New York Heart Association stage III/IV or echocardiography suggesting left ventricular ejection fraction 3 times the upper limit of normal (ULN); total bilirubin >3 times the ULN; (3) Abnormal renal function: estimated glomerular filtration rate (eGFR) <60mL/min/1.73m^2 or any uncontrolled clinically significant laboratory test abnormality judged by the investigator to be likely to affect the interpretation of the study data or the subject's participation in the study; 6. Patients with a positive human immunodeficiency virus antibody (anti-HIV-Ab) test, active syphilis, active hepatitis C (hepatitis C antibody positive and HCV-RNA positive), HBsAg positive and HBV-DNA positive during the Screening Period may not be enrolled in the study; and patients with a history of severely active or recurrent bacterial, viral, fungal, parasitic or other infections during the Screening Period ; 7. Live/attenuated vaccination within 2 months prior to enrollment; 8. Any of the following within 3 months prior to enrollment: (1) major trauma or major surgery (including joint surgery), or major surgery required during the study period, which, in the opinion of the investigator, poses an unacceptable risk to the subject; (2) treatments such as plasma exchange or extracorporeal light replacement; (3) subjects participating in any other clinical trial; 9. History of any malignancy within 5 years prior to enrollment, except adequately treated or excised basal cell carcinoma of the skin or squamous cell carcinoma of the skin or cervical cancer in situ; 10. Intolerance or contraindication to study treatment, including any of the following: (1) Hypersensitivity or allergy to any of the components in the excipients of the product; (2) No peripheral venous access; 11. Have plans to have children for at least 2 years after injection administration, or are unwilling to use effective contraception with their partner, or have plans for sperm or egg donation; 12. Those who are not suitable for PET/CT, such as those who suffer from claustrophobia; 13.Persons who, in the judgment of the investigator, are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine SUV value;Fecal SUV value;Blood Cmax;Blood t1/2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rodnan Skin Score (mRSS);Percentage of FVC projections;Health Assessment Questionnaire Disability Index (HAQ-DI); | — |
Countries
China
Contacts
Public ContactMiao Liyan; Wu Jian
The First Hospital of Suzhou University
Outcome results
None listed