Status:
NOT_YET_RECRUITING
Study on Safety and Efficacy of UCB-MNCs for Radiation-induced Lung Injury
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Radiation-induced Lung Injury
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
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 thera...
Eligibility Criteria
Inclusion
- Ages 18-75 years,with no restriction on gender;
- History of chest radiotherapy;
- 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";
- Inadequate response to conventional treatment for two weeks, with no relief or progressive worsening of symptoms;
- Well-controlled tumor for ≥3 months;
- 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;
- Expected survival ≥ 3 months;
- Informed consent signed voluntarily by the patient;
- 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
- Severe cardiac insufficiency (such as NYHA class III or IV), uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg);
- Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;
- ECOG score ≥2;
- Currently participating in or participated in other clinical trials within 4 weeks;
- History of allergies or known allergy to the study preparation;
- Patients with psychiatric disorders who cannot cooperate with treatment; (7) Pregnant or lactating women.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07177456
Start Date
October 1 2025
End Date
December 31 2026
Last Update
September 17 2025
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