Not Yet RecruitingEarly Phase 1

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

10 participantsStarted 2025-10-01

Plain-language 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 therapeutic effect and adverse reactions of UCB-MNCs in treating RILI .

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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.

What they're measuring

Chest Enhanced CT Scan report

Timeframe: Baseline and at 1、3、6 and 12 months after the last treatment.

Trial details

NCT IDNCT07177456

SponsorZhejiang Cancer Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

Ji ZHU

0571-88128212 zhuji@zjcc.org.cn

View on ClinicalTrials.gov More Radiation-induced Lung Injury trials