Clinical Study on Adoptive Treatment of Multidrug Resistant Pulmonary Tuberculosis With Allogeneic γδT Cells
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- sputum smear
研究概览
简要总结
Brief summary: Allogeneic γδT cells from healthy donor will be administrated intravenously to patients with the MDR-TB，and then the safety and efficacy of γδT cells will be evaluated.
详细描述
All patients with multi-drug resistant pulmonary tuberculosis will be assigned into 2 groups(study group and control group)，both groups will receive conventional treatment. Allogeneic γδT cell will be administrated intravenously to patients in the study group (but not the control group) every two weeks for 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-50 years old, male or female;
- •Informed consent;
- •Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture.
排除标准
- •AIDS, hepatitis B and other viruses, bacterial infections;
- •Patients with other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system diseases, mental diseases, neurological diseases, and vascular circulatory diseases;
- •Others After being evaluated by clinicians participating in this project, it is not suitable to participate in immune cell therapy;
- •Those who do not agree to be included.
研究组 & 干预措施
Control Group
Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells.
干预措施: Control (Other)
Study group
Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells.
干预措施: The adoptive treatment of allogeneic γδT cells (Biological)
Study group
Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells.
干预措施: Conventional treatment (Drug)
Control Group
Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells.
干预措施: Conventional treatment (Drug)
结局指标
主要结局
sputum smear
时间窗: 6 months
The sputum specimens will be collected biweekly in the first 2 months and bimonthly thereafter for sputum smear to study the time (months) of the sputum conversion. The sputum conversation rate will be analyzed at the end of study.
次要结局
- Assessment of immune function(6 months)
- Sputum tubercle bacillus culture(6 months)
- Fecal microbiome analysis(6 months)
研究者
Zhinan Yin, Ph.D.
Dean of Biomedical Translational Research Institute，jinan University
Jinan University Guangzhou