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

University of Chinese Academy Sciences

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Radiation-induced Lung Injury

Treatments: Biological: UCB-MNCs

Study type: Interventional

Funder types: Other

Identifiers

NCT07177456

2025&UCB-MNCs&RILI

Details and patient eligibility

About

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 .

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

UCB-MNCs

Experimental group

Description:

UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation

Treatment:

Biological: UCB-MNCs