human umbilical cord mesenchymal stem cell injection for the treatment of interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: main objective: to explore the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ild); secondary objective: to explore the preliminary effectiveness of human umbilical cord mesenchymal stem cell therapy for interstitial lung disease (ild) and recommend appropriate cell therapy doses for subsequent clinical studies; exploring the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ild).


Eligibility criteria:
inclusion criteria: * gender not limited, age ≥ 18 years old (including threshold); * clinical diagnosis of interstitial lung disease; * blood biochemistry tests must meet the following criteria: alanine aminotransferase (alt) ≤ 2.5 × uln, aspartate aminotransferase (ast) ≤ 2.5 × uln, total bilirubin (tbil) ≤ 2 × uln, direct bilirubin (dbil) ≤ 1.5 × uln, or creatinine (cr) ≤ 3 × uln; * the diffusion capacity of carbon monoxide (dlco) (corrected by hb) in lung function tests within the previous 3 months is 30% to 80% of the expected value (including 30% and 80%); forced vital capacity (fvc) is 40% to 70% of the estimated value (including 40% and 70%) exclusion criteria: * within the first 3 days of enrollment, use high-dose corticosteroids (equivalent to methylprednisolone\>240 mg/day) or irregularly use systemic corticosteroids; * for patients receiving immunosuppressive therapy, unstable background treatment with cyclophosphamide, mycophenolate mofetil/sodium, methotrexate, or other immunosuppressive monotherapy is not allowed (combination therapy is not allowed) * diagnose ipf patients who have previously taken drugs that may cause or worsen pulmonary fibrosis; * individuals with a history of mechanical ventilation or concurrent infectious pneumonia or asthma within the previous month prior to screening; patients with airway obstruction disease (fev1/fvc\ 15h/d); * pregnant and lactating women * screening for malignant tumors that have occurred within the past 5 years, excluding cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma that have been previously treated for curative purposes; * individuals who have been hospitalized for 3 or more times due to acute exacerbation of ild or other respiratory diseases within the past year prior to screening * there is evidence that subjects currently have digestive system, urinary system, cardio cerebrovascular, blood system, nervous system, mental and metabolic diseases that may affect safety, such as type 2 diabetes with poor blood sugar control, hypertension with poor blood pressure control, etc * have a history of abuse or drug use of psychotropic substances * individuals allergic to human serum albumin, anesthetics, or their components * select participants who have participated in any other clinical trials within the previous 3 months; * individuals who have previously received stem cell therapy * researchers have determined that the expected survival period may be less than 1 year; * subjects who cannot tolerate bronchoscopy examination (including but not limited to: active massive hemoptysis; severe hypertension and arrhythmia;

Keywords: interstitial lung disease ild