Systemic sclerosis-associated interstitial lung disease
Conditions
Interventions
Control Group:Normal saline 5 mL, nebulized inhalation, once weekly for a total of 9 times
Low-dose hUCMSCs-MVs Group:hUCMSCs-MVs 1×10^11 nanoparticles per person, nebulized inhalation, once weekly for a total of 9 times
Medium-dose hUCMSCs-MVs Group:hUCMSCs-MVs 5×10^11 nanoparticles per person, nebulized inhalation, once weekly for a total of 9 times
High-dose hUCMSCs-MVs Group:hUCMSCs-MVs 2.5×10^12 nanoparticles per person, nebulized inhalation, once weekly for a total of 9 times
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Study Participants: 1. Age 18–65 years (inclusive), either gender. 2. Diagnosed with systemic sclerosis according to the 2013 ACR/EULAR classification criteria. 3. Clearly diagnosed with interstitial lung disease (ILD), with high-resolution CT (HRCT) score ranging from 2 to 3. (Note: Assessment layers include the aortic arch, carina, and 1 cm above the diaphragm; scoring is performed separately for ground-glass opacities, reticular changes, and honeycombing. 0 points: no change; 1 point: involvement =5%; 2 points: involvement 5%–25%; 3 points: involvement 25%–50%; 4 points: involvement 50%–75%; 5 points: involvement >75%. Total HRCT score is the sum of the three categories.) 4. Treated with conventional DMARDs and corticosteroids for at least 3 months with inadequate improvement in respiratory symptoms, and forced vital capacity as percentage of predicted value (FVC%) between 40% and 80% (inclusive of 40%, exclusive of 80%) or carbon monoxide diffusing capacity as percentage of predicted value (DLco%) between 30% and 80% (inclusive). 5. No participation in other clinical trials within the past 6 months; voluntarily enrolled in this study with good compliance; capable of understanding and providing informed consent prior to the study. Donors: 1. The umbilical cord donor’s family has no genetic disorders, including autosomal dominant/recessive or polygenic genetic diseases. 2. The umbilical cord donor’s family has no autoimmune diseases, including systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, hyperthyroidism, juvenile diabetes, idiopathic thrombocytopenic purpura, or autoimmune hemolytic anemia. 3. The mother has no malignancies or other chronic diseases. 4. The mother has no parasitic infections or other endemic diseases. 5. Prenatal viral screening for the mother is negative for HBV, HIV, HCV, and syphilis. 6. Signed the Umbilical Cord Storage Agreement.
Exclusion criteria
Exclusion criteria: Study Participants: 1. ALT or AST > 3 times the upper limit of normal (ULN). 2. Total bilirubin (TBiL) > 1.5 times ULN. 3. Creatinine clearance 2, prothrombin time (PT) or activated partial thromboplastin time (APTT) prolonged >1.5 times ULN, etc. 10. Conditions that may interfere with study procedures (e.g., inability to tolerate pulmonary function testing without supplemental oxygen) or other diseases or comorbidities that, in the investigator’s judgment, may compromise study participation or place the patient at risk. 11. History of thrombotic event (including stroke and transient ischemic attack) within the past 12 months. 12. Prior hematopoietic stem cell transplantation (HSCT), or planned HSCT within the next year. 13. Planned major surgery during the study period. 14. Female patients who are pregnant, breastfeeding, or planning to become pregnant during the study. 15. Women of childbearing potential unwilling or unable to use highly effective contraception from 28 days prior to dosing through 3 months after dosing. 16. Alcohol abuse or drug dependence, as determined by the investigator. 17. Patients unable to understand or comply with study procedures. 18. Patients with psychiatric disorders. 19. Participation in another drug clinical trial within the past 3 months. 20. Use of the following medications: (1) Nintedanib or pirfenidone within the past 3 months; (2) Prednisone >30 mg/day or equivalent glucocorticoid dose within the past 3 months; (3) Biologics (TNF antagonists, CD20 inhibitors, IL-6 inhibitors, abatacept) within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine, biochemical profile, coagulation profile, Pre-transfusion Panel (for HBV, HCV, HIV, TP), tumor markers (AFP, CEA, CA199)?Urine routine test.;A 12-lead electrocardiogram;Fever, rash, tachypnea, dyspnea and epilepsy;Immunoglobulin, T cell subsets, B cell subsets, NK cells, ANA, dsDNA, ENA, complement, ESR, CRP, ferritin?IL 6;Body temperature, heart rate, blood pressure, respiratory rate, and oxygen saturation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lung High Resolution CT(HRCT);6-minute walk distance (6MWD) 36-Item Short Form Survey (SF-36) St. George’s Respiratory Questionnaire (SGRQ).;Pulmonary function and KL-6; | — |
Countries
China
Contacts
Public ContactLiu Yi
West China Hospital of Sichuan University
Outcome results
None listed