NCT07177456尚未招募1 期
Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Radiation-induced Lung Injury
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Chest Enhanced CT Scan report
研究概览
简要总结
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
UCB-MNCs
Experimental
UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
干预措施: UCB-MNCs (Biological)
结局指标
主要结局
Chest Enhanced CT Scan report
时间窗: Baseline and at 1、3、6 and 12 months after the last treatment.
Evaluate changes in lung damage ，and calculate the change in total lesion volume as a percentage of total lung volume.
次要结局
- 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.)
- Change from baseline in lung Carbon Monoxide Diffusion Capacity (DLCO)(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(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)(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)(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)(We measured PCO2 at baseline and at 1、3 、6 months and 12 months after the last treatment.)
研究者
Ji Zhu
Principal Investigator
Zhejiang Cancer Hospital
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