Status:
UNKNOWN
Dead Mesenchymal Stem Cells for Radiation Lung Injury
Lead Sponsor:
Sichuan University
Conditions:
Radiation Lung Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of hDMSCs in the treatment of radiation pneumonitis.
Detailed Description
As a single-center, single-arm, prospective clinical trial, this study aims to explore the safety and efficacy of hDMSCs in the treatment of radiation pneumonia. This study will include patients who h...
Eligibility Criteria
Inclusion
- Received chest radiotherapy;
- EOCG PS score of 0 to 3 points;
- Diagnosis of radiation lung injury by the attending physician, grade 2 to 3 (according to the CTCAE v5.0 standards);
- Main organs function is normal, that meet the following criteria: blood routine examination (within 7 days of unused hematopoietic growth factors and blood transfusion) : ANC ≥ 1.5 x 10\^9 / L, PLT ≥ 80 x 10\^9 / L, HGB ≥ 80 g/L;Biochemical examination: TBil ≤ 1.5 x ULN (upper limit of normal);ALT or AST ≤ 2.5 x ULN; Creatinine clearance ≥ 60 mL/min (Cockcroft - Gault formula); Blood coagulation function: INR or PT ≤ 1.5 x ULN, if the subjects are receiving anticoagulant therapy, as long as the scope of PT in anticoagulant drugs for it. Heart function examination, electrocardiogram (ECG) normal or abnormal ECG (by the researchers to determine the clinical significance). Heart doppler ultrasound assessment: LVEF ≥ 50%;
- Radiation lung injury lasts less than 2 months；
- Survival expectation ≥6 months;
- Signed and dated written informed consent
Exclusion
- Pregnant or lactating women, men and women of childbearing age who are unwilling or unable to take effective contraceptive measures;
- People with a history of chronic bronchitis, emphysema, or cor pulmonale;
- History of lung resection surgery;
- Tumor progression;
- People with severe lung infection;
- Uncontrollable severe systemic diseases (e.g., central nervous system, cardiovascular system, blood system, digestive system, endocrine system, respiratory system, genitourinary system, immune system, etc.) and psychosis;
- Serious cardiovascular events: a period of 6 months in heart failure (NYHA class III level IV), myocardial infarction, unstable angina, severe arrhythmia, cerebral infarction, cerebral hemorrhage;
- Abnormal liver and kidney function: AST and ALT exceed the upper limit of normal by 2.5 times. Serum creatinine is greater than 1.5 mg/dl in men and 1.4 mg/dl in women;
- Co-infection with HIV, Treponema pallidum, tuberculosis, influenza virus, adenovirus and other respiratory infections;
- Hemorrhage or thrombosis, bleeding or anticoagulant drugs;
- Combined with cachexia or other organ failure (requiring organ support);
- Shock or invasive ventilation;
- Combined with pulmonary interstitial pneumonia caused by other reasons or damage, or lung imaging showed radioactive lung injury diagnosed with pulmonary interstitial pneumonia or damage before;
- Patients who have participated in clinical studies of stem cells;
- The investigators believed that there were other reasons why participants were not suitable for the study.
Key Trial Info
Start Date :
September 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06021067
Start Date
September 10 2023
End Date
September 30 2024
Last Update
September 1 2023
Active Locations (1)
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1
West China Hospital
Chengdu, Sichuan, China, 610000