To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease.
To evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease (CTD-ILD).
Both sexes, aged 18-80 years;
Pulmonary fibrosis ≥10% was confirmed by high-resolution chest computed tomography (HRCT);
A decline of 10% or more in the percentage of predicted forced vital capacity (FVC%p) within 24 months (significant decline in ventilatory function) despite treatment;
A decline of ≥5% in FVC%p + a decline of ≥15% in DLco (a decline in ventilation function + a decline in diffusion capacity) within 24 months despite treatment;
The patients were diagnosed with other lung diseases other than SSc-ILD, such as COPD, lung abscess, lung cancer and other types of connective tissue disease-related interstitial lung disease.
Have obvious acute lung infection requiring anti-infection treatment (treatment of 4 weeks prior to the start of the respiratory tract infection and systemic infection);
History of severe pulmonary hypertension, including right heart failure, cardiac intubation, and parenteral administration of prostaglandin analogues;
History of myocardial infarction or angina pectoris within 6 months before enrollment;