Study on Safety and Efficacy of UCB-MNCs for Radiation-induced Lung Injury

Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Radiation-induced Lung Injury

This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for radiation-induced lung injuryr (RILI) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating RILI .

Inclusion Criteria:

1. Ages 18-75 years,with no restriction on gender;
2. History of chest radiotherapy;
3. Diagnosed with grade 2-3 radiation-induced lung injury according to CTCAE 4.0 classification criteria in "Diagnosis and Treatment of Radiation-induced Lung Injury";
4. Inadequate response to conventional treatment for two weeks, with no relief or progressive worsening of symptoms;
5. Well-controlled tumor for ≥3 months;
6. No significant liver or kidney dysfunction: ALT, AST ≤ 3 times the upper limit of normal, serum Cr and BUN ≤ 2 times the upper limit of normal;
7. Expected survival ≥ 3 months;
8. Informed consent signed voluntarily by the patient;
9. Willing and able to receive treatment and follow-up as required by the protocol, and able to comply with basic treatment as directed by the physician.

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. Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;
3. ECOG score ≥2;
4. Currently participating in or participated in other clinical trials within 4 weeks;
5. History of allergies or known allergy to the study preparation;
6. Patients with psychiatric disorders who cannot cooperate with treatment; (7) Pregnant or lactating women.