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

NCT07177456 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2025&UCB-MNCs&RILI
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Conditions

Radiation-induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• Chest Enhanced CT Scan report

  Evaluate changes in lung damage ，and calculate the change in total lesion volume as a percentage of total lung volume.

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

Secondary Outcomes (10)

• Modified Medical Research Council Dyspnea Scale (mMRC Score)

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

• 6-minute walking distance test（6MWT）

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

• Change from baseline in forced expiratory volume in 1st second (FEV1)

  We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment.

• Change from baseline in forced vital capacity (FVC)

  We measured FVC at baseline and at 1、3 、6 months and 12 months after the last treatment.

• Change from baseline in FEV1/FVC ratio

  We measuredFEV1/ FVC at baseline and at 1、3 、6 months and 12 months after the last treatment.

Study Arms (1)

UCB-MNCs

EXPERIMENTAL

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

Biological: UCB-MNCs

Interventions

UCB-MNCs BIOLOGICAL

UCB-MNCs were administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.

UCB-MNCs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Central Study Contacts

Ji ZHU

CONTACT

0571-88128212; zhuji@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share