Radiation pneumonitis
Conditions
Interventions
Trial group:Treatment with umbilical cord blood mononuclear cells (UCB-MNCs) combined with umbilical cord mesenchymal stem cell-derived exosomes (UCMSC-exos).
Control group:Standardized treatment protocol
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18-75 years, regardless of gender; 2. History of chest radiotherapy with symptoms of pneumonia developing after treatment; 3. Diagnosed with grade 2-3 radiation pneumonitis according to CTCAE 5.0 classification criteria in the "Chinese Expert Consensus on Diagnosis and Treatment of Radiation-induced Pneumonitis"; 4. Well-controlled tumor for >=3 months (i.e., no progression or stable disease confirmed by imaging); 5. No significant liver or kidney dysfunction: ALT, AST = 3 months; 7. Signed informed consent form; 8. Willing and able to receive treatment and follow-up as required by the protocol, and able to follow basic treatment instructions.
Exclusion criteria
Exclusion criteria: 1. Severe cardiac insufficiency (such as NYHA class III or IV), uncontrolled hypertension (systolic blood pressure >=160mmHg or diastolic blood pressure >=110mmHg); 2. Hepatitis B (HBsAg positive and HBV DNA >=2000IU/mL), hepatitis C (HCV-Ab positive and HCV-RNA > upper limit of normal), human immunodeficiency virus (HIV) antibody positive, Treponema pallidum antibody positive; 3. ECOG score >=2 points; 4. Currently participating in or participated in other clinical trials within 4 weeks; 5. Patients with allergic constitution or known allergy to the trial preparations (umbilical cord blood mononuclear cells, mesenchymal stem cell exosomes); 6. Patients with mental illness who cannot cooperate with treatment; 7. Pregnant or lactating women; 8. Uncontrolled infections (such as septicemia, active tuberculosis, etc.); 9. Severe coagulation dysfunction (INR >1.5 or APTT >1.5 times the upper limit of normal); 10. Patients with a history of myocardial infarction or stroke within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest Enhanced CT Scan; | — |
Secondary
| Measure | Time frame |
|---|---|
| mMRC score;6-minute walk distance;Pulmonary function parameters (FEV1, FVC, FEV1/FVC, DLCO);Blood gas analysis indices (pH, PaO2, SaO2, PaCO2);Inflammatory factors and fibrosis markers;Immune function; | — |
Countries
China
Contacts
Public ContactZang Chunbao
Anhui Provincial Cancer Hospital
Outcome results
None listed