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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Allogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months.
No allogeneic γδT cells will be administered to patients with MDR-TB.
Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China
RECRUITINGsputum smear
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.
Time frame: 6 months
Sputum tubercle bacillus culture
The sputum specimens will be collected for culture to detect the TB biweekly in the first 2 months and bimonthly thereafter to study the time (months) of the sputum conversion. The sputum conversation rate will be analyzed at the end of study.
Time frame: 6 months
Fecal microbiome analysis
The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter.
Time frame: 6 months
Assessment of immune function
Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic γδT cells .
Time frame: 6 months
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