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

Early Phase 1Not Yet RecruitingNCT07177456

Zhejiang Cancer Hospital10 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Radiation-induced Lung Injury

Interventions

UCB-MNCsBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Modified Medical Research Council Dyspnea Scale (mMRC Score)

mMRC Score is a subjective scale for assessing the severity of breathing difficulties,dyspnea is classified into five grades (0 to 4). The higher the grade, the more severe the symptoms and the more obvious the limitation of movement.

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

6-minute walking distance test（6MWT）

The 6-minute walking distance (6MWD) is a method for assessing a patient's cardiopulmonary function and exercise endurance by measuring the maximum distance they can walk as fast as possible within 6 minutes.

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

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

FEV1 is the maximal volume of air that can be expired in 1st second of forced vital capacity maneuver using spirometry. We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment.

Time frame: 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)

Forced vital capacity (FVC) is the maximal volume of air that can be expired while patient performs forced expiration as fast and as deep as possible using spirometry. We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment.

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

Central Contacts

Ji ZHU

CONTACT

0571-88128212 zhuji@zjcc.org.cn

Data from ClinicalTrials.gov

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