Idiopathic pulmonary fibrosis
Conditions
Interventions
Received intravenous infusion of SC01009 injection and placebo at weeks 1 and 13 respectively.:placebo and SC01009 injection
Received intravenous infusion of SC01009 injection and placebo at weeks 1 and 13 respectively.:placebo
Group 1: received intravenous infusion of SC01009 injection at a total dose of 9×107 cells in the first and thirteenth weeks respectively
Group 2: received intravenous infusion of SC01009 injection at a total dose of 9×107 cells in the first week and placebo in the thirteenth week respectively.:SC01009 injection
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the written informed consent form (ICF) and agree to complete the trial according to the protocol requirements; 2. Age >=18 years old and =50% and =30% and =60 mmHg at screening; Able to complete the 6-minute walk test (6MWT) and the walking distance > 150 m; 7. Subjects of childbearing potential (including spouses of male subjects) who are willing to use at least one effective contraceptive measure for contraception during the study.
Exclusion criteria
Exclusion criteria: 1. Other pulmonary diseases within 6 months prior to screening, including chronic obstructive pulmonary disease (forced expiratory volume/forced vital capacity (FEV1/FVC) =50% of the entire HRCT according to the central review of HRCT, or the degree of emphysema is greater than the degree of fibrosis), cardiac ultrasound suggests pulmonary hypertension >=50 mmHg, active tuberculosis, pulmonary embolism, uncontrolled asthma, pneumothorax, pneumoconiosis, Bronchiolitis obliterans or other active pulmonary disease; 2. Other types of interstitial lung disease (ILD) other than IPF, including ILD with known etiology (such as exposure to the home or occupational environment, connective tissue disease, drug toxicity, etc.), granulomatous ILD (such as sarcoidosis), and other rare ILDs (such as alveolar proteinosis, pulmonary amyloidosis, etc.); Among them, for the exclusion of connective tissue disease-associated interstitial lung disease (CTD-ILD), relevant examinations within 12 months prior to screening; 3. In the acute exacerbation phase of IPF at screening, or AE-IPF within 3 months before screening (determined by the investigator); AE-IPF is defined as: patients with IPF have significant acute respiratory deterioration in the short term, mainly characterized by new diffuse ground-glass shadows and/or consolidated shadows in both lungs on the background of chest HRCT (see Appendix 2 for diagnostic criteria); 4. Those who have lung infection or other serious infections requiring intravenous antibiotic treatment within 4 weeks before screening; 5. History or evidence of major cardiovascular disease within 6 months before screening, including but not limited to: myocardial infarction, coronary angioplasty or bypass grafting, heart valve repair, second-degree or III atrioventricular block, malignant arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.), unstable angina, transient ischemic attack, cerebrovascular accident, congestive heart failure with New York Heart Association (NYHA) cardiac function class III or IV, etc.; or left ventricular ejection fraction (LVEF) 3×upper limit of normal (ULN), or total bilirubin (TBIL) >1.5× ULN at screening; 8. Estimated glomerular filtration rate (eGFR) = lower limit of detection value, or positive hepatitis C virus (HCV) antibody and hepatitis C virus ribonucleic acid (HCV-RNA) >= lower limit of detection value, or positive human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody positive (those who are positive for Treponema pallidum antibody need to be tested for syphilis non-specific antibody and judged by the investigator to participate in the test); 10. Blood pressure is still uncontrolled after antihypertensive drug tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FVC; | — |
Secondary
| Measure | Time frame |
|---|---|
| DLCO;FVC;Laboratory tests, vital signs, physical examination, ECG;FVC%;Infusion reaction;L-PF Impacts?(L-PF Symptoms;AE)/(SAE);DLCO%;PaO2; | — |
Countries
China
Contacts
Public ContactQu jieming
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed