Radiation-induced Pulmonary Fibrosis
Conditions
Interventions
UC-MSC treatment group:Human umbilical cord MSCs are transplanted by intravenous infusion(1×10^8/person) once every other week, a total of three times.
Control group:Patients will receive the conventional treatment
Sponsors
Yunnan Tumor Hospital /The Third Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged 18-70 years old; 2) Subjects with a clear history of malignancy; 3) Subjects with a clear history of chest radiation therapy at least 3 months earlier; 4) Subjects diagnosed as chronic phase of radiation-induced pneumonitis or radiation-induced pulmonary fibrosis stage (see Annex 3 for diagnosis); 5) Subjects signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures; 2) Subjects with syphilis or HIV positive antibody; 3) Subjects with infection aggravated within the past month; 4) Subjects suffering from any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, severe pneumonia, acute exacerbation of chronic bronchitis, AECOPD, severe and / or extremely severe COPD, etc.; 5) Subjects suffering from other serious diseases, such as myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis; 6) Subjects with progression-free survival (PFS) less than 0.5 years or Karnofsky performance scores less than 60 points; 7) Subjects with leukopenia (WBC less than 4x10^9/L) or agranulocytosis (WBC less than 1.5x10^9/L or neutrophils less than 0.5x10^9 / L) caused by any reason; 8) Subjects with severe renal impairment, serum creatinine> 1.5 times the upper limit of normal; 9) Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times the upper limit of normal; 10) Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders; 11) Subjects with severe arrhythmias (such as ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter, etc.) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG; 12) Subjects with a history of alcohol or illicit drug abuse; 13) Subjects accepted by any other clinical trials within 3 months before the enrollment; 14) Subjects with poor compliance, difficult to complete the study; 15) Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite indicators of UC-MSC on Radiation-induced Pulmonary Fibrosis.; | — |
Countries
China
Contacts
Public ContactDong Jian
Yunnan Tumor Hospital /The Third Affiliated Hospital of Kunming Medical University
Outcome results
None listed