Acute exacerbation of interstitial lung disease
Conditions
Interventions
Experimental drug low dose group:Basic treatment +CAStem cells 1×10^6 cells /kg, intravenous infusion, once a week, a total of 3 times
Experimental drug high dose group:Basic treatment +CAStem cells 3×10^6 cells /kg, intravenous infusion, once a week, a total of 3 times
Placebo control group:Basic treatment + placebo injection, intravenous infusion, once a week, a total of 3 times
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years, =75 years; 2) For those who have been diagnosed with ILD or are currently diagnosed with acute respiratory exacerbation, the following three criteria are met: ? The time of acute respiratory deterioration is usually less than 1 month; (2) Chest HRCT confirmed the appearance of new diffuse ground glass shadows and/or solid shadows of both lungs on the background of fibrotic ILD manifestations such as reticular shadows or honeycomb shadows or tractable bronchiectasis; The worsening of dyspnea could not be explained by heart failure or fluid overload; 3) Voluntarily participate in this study, agree to comply with the requirements of the clinical trial protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1: Have a history of severe allergy or allergy to the main active ingredient or excipient of the drug, such as human blood albumin or dimethyl sulfoxide (DMSO) 2: Patients who had a history of AE-ILD within the past 3 months and were considered unfit to participate in the study 3: Currently suffering from severe pneumothorax or massive pleural effusion 4: WHO grade III or IV pulmonary hypertension 5: Pulmonary embolism has been diagnosed 6: Currently has arrhythmia affecting hemodynamics 7: Patients undergoing mechanical ventilation with tracheal intubation 8: Patients undergoing extracorporeal membrane oxygenation (ECMO), continuous kidney replacement therapy (CRRT), polymyxin-B fixed fiber hemoperfusion (PMX-DHP), plasma exchange and other forms of extracorporeal life support 9: Prospective lung transplant recipients in the near future 10: Patients with connective tissue disease or systemic vasculitis 11: Patients with other serious chronic respiratory diseases, such as chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, etc., or current PaCO2 >50mmHg associated with any cause, and the investigators believe that it is not appropriate to participate in this study 12: People with primary immunodeficiency 13: Patients with a history of malignant tumor or severe atypical hyperplasia without treatment 14: Currently have active infectious diseases, including but not limited to human immunodeficiency virus (HIV) antibody positive, active tuberculosis, etc., and the investigator considers it inappropriate to participate in this study 15: Body mass index (BMI) =35 kg/m2 16: Those who have received immune cell therapy within 3 months 17: Organ transplant patients requiring immunosuppressive therapy 18: Women who are pregnant or nursing or plan to become pregnant during the study, or women or men of childbearing age who are not willing to use contraception throughout the trial 19: Use of another investigational drug within 28 days prior to initiation of treatment, and the investigational drug in question is determined by the investigator to interfere with the evaluation of the safety and efficacy of the investigational drug 20: The investigator considered that participation in this study was not in the best interest of the subjects or was not suitable for other circumstances, such as poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality of 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| The recurrence rate of AE, the time of first AE recurrence after medication, and the number of AE recurrence;PaO2, oxygenation index, P (A-a) O2 change from baseline;Changes in chest HRCT scores improve from baseline;Improvement in lung function;Improvement in 6-MWT ;mMRCimprovement from baseline;Improvement in SGRQ scores;mortality ;Clinical benefits of composite indicators of adverse outcomes(invasive ventilation through tracheal intubation, ECMO, lung transplantation); | — |
Countries
China
Contacts
Public ContactHuaping Dai
China-Japan Friendship Hospital
Outcome results
None listed