Not yet recruiting NCT07177456
Study on Safety and Efficacy of UCB-MNCs for Radiation-induced Lung Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UCB-MNCs.
- Who it may be relevant to
- Registry conditions: Radiation-induced Lung Injury. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Radiation-induced Lung Injury
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 .
Interventions
- Biological UCB-MNCs
UCB-MNCs were administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion.
Primary outcome measures
- Chest Enhanced CT Scan report [Time frame: Baseline and at 1、3、6 and 12 months after the last treatment.]
Secondary outcome measures (10)
- Modified Medical Research Council Dyspnea Scale (mMRC Score) [Time frame: Baseline and at 1、3 、6 and 12 months after the last treatment.]
- 6-minute walking distance test（6MWT） [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) [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) [Time frame: 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 [Time frame: We measuredFEV1/ FVC at baseline and at 1、3 、6 months and 12 months after the last treatment.]
- Change from baseline in lung Carbon Monoxide Diffusion Capacity (DLCO) [Time frame: We measured DLCO at baseline and at 1、3 、6 months and 12 months after the last treatment.]
- Arterial blood gas parameter like pH value [Time frame: We measured pH value at baseline and at 1、3 、6 months and 12 months after the last treatment.]
- Arterial blood gas parameter like partial pressure of oxygen (PO2) [Time frame: We measured PO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.]
- Arterial blood gas parameter like oxygen saturation (SO2) [Time frame: We measured SO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.]
- Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2) [Time frame: We measured PCO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.]
Eligibility criteria
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;
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07177456 · 2025&UCB-MNCs&RILI