Status:
COMPLETED
A Study on Radiation-induced Pulmonary Fibrosis Treated With Clinical Grade Umbilical Cord Mesenchymal Stem Cells
Lead Sponsor:
Jianwu Dai
Collaborating Sponsors:
Southwest Hospital, China
Conditions:
Post-radiotherapy Pulmonary Fibrosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Radiation therapy is one of the main means for treating malignant tumor, during which radioactive lung injury is inevitable. Currently there is nearly no effective clinical treatment for late post-rad...
Eligibility Criteria
Inclusion
- Male or female, 18-70 years old.
- Subjects with a clear history of malignancy.
- Subjects with a clear history of chest radiation therapy at least 3 months earlier.
- Subjects diagnosed as chronic phase of radiation-induced pneumonitis or radiation-induced pulmonary fibrosis stage (see Annex 3 for diagnosis).
- Subjects signed informed consent.
Exclusion
- Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures.
- Subjects with syphilis or HIV positive antibody.
- Subjects with infection aggravated within the past month.
- 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..
- Subjects suffering from other serious diseases, such as myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis.
- Subjects with progression-free survival (PFS) less than 0.5 years or Karnofsky performance scores less than 60 points.
- Subjects with leukopenia (WBC less than 4x109 / L) or agranulocytosis (WBC less than 1.5x109 / L or neutrophils less than 0.5x109 / L) caused by any reason.
- Subjects with severe renal impairment, serum creatinine\> 1.5 times the upper limit of normal.
- Subjects with liver disease or liver damage: ALT, AST, total bilirubin\> 2 times the upper limit of normal
- Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
- 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.
- Subjects with a history of alcohol or illicit drug abuse.
- Subjects accepted by any other clinical trials within 3 months before the enrollment
- Subjects with poor compliance, difficult to complete the study.
- Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02277145
Start Date
October 1 2014
End Date
December 1 2018
Last Update
July 24 2019
Active Locations (1)
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1
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
Chongqing, Chongqing Municipality, China, 400038