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| Name | Class |
|---|---|
| Shenzhen Third People's Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells. |
|
| Control Group | Placebo Comparator | Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The adoptive treatment of allogeneic γδT cells | Biological | Allogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| sputum 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Fecal microbiome analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhinan Yin, Ph.D. | Contact | (+86)18818801179 | zhinan.yin@yale.edu | |
| Yangzhe Wu, Ph.D. | Contact | (+86)18826469480 | 190374157@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Guofang Deng, Master | Partner | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Third People's Hospital | Recruiting | Shenzhen | Guangdong | 518000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34975844 | Derived | Liang J, Fu L, Li M, Chen Y, Wang Y, Lin Y, Zhang H, Xu Y, Qin L, Liu J, Wang W, Hao J, Liu S, Zhang P, Lin L, Alnaggar M, Zhou J, Zhou L, Guo H, Wang Z, Liu L, Deng G, Zhang G, Wu Y, Yin Z. Allogeneic Vgamma9Vdelta2 T-Cell Therapy Promotes Pulmonary Lesion Repair: An Open-Label, Single-Arm Pilot Study in Patients With Multidrug-Resistant Tuberculosis. Front Immunol. 2021 Dec 15;12:756495. doi: 10.3389/fimmu.2021.756495. eCollection 2021. |
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| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| Control | Other | No allogeneic γδT cells will be administered to patients with MDR-TB. |
|
| Conventional treatment | Drug | Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study. |
|
The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter. |
| 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 . | 6 months |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |