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;
Parallel
MSC
Biological/Vaccinea single injection dose i.v.
AE
Adverse events and serious adverse events.
Forced Vital Capacity（FVC）
Absolute change in FVC
Forced Expiratory Volume in One Second (FEV1)
Forced expiratory volume in 1 second (FEV1)
Diffusing Capacity of the Lung for Carbon Monoxide (DLco)
Absolute change in carbon monoxide diffusing capacity (DLco)
St. George's Respiratory Questionnaire (SGRQ）
Score range: 0-100； Higher scores indicate worse health status, while lower scores indicate better health； Changes in the St George's Respiratory questionnaire (SGRQ)
Short Form Health Survey (SF-36)
Score range: 0-100； Higher scores indicate better health status, while lower scores indicate worse health； Changes in the Short Form Health Survey (SF-36)；
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