Multi-drug Resistant Tuberculosis
Conditions
Keywords
MDR-TB, Allogeneic γδT cells, adoptive treatment
Brief summary
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.
Detailed description
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
Interventions
BIOLOGICALThe adoptive treatment of allogeneic γδT cells
Allogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months.
OTHERControl
No allogeneic γδT cells will be administered to patients with MDR-TB.
DRUGConventional treatment
Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.
Sponsors
Shenzhen Third People's Hospital
Zhinan Yin, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-50 years old, male or female; 2. Informed consent; 3. Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture.
Exclusion criteria
1. AIDS, hepatitis B and other viruses, bacterial infections; 2. Patients with other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system diseases, mental diseases, neurological diseases, and vascular circulatory diseases; 3. Others After being evaluated by clinicians participating in this project, it is not suitable to participate in immune cell therapy; 4. Those who do not agree to be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sputum smear | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sputum tubercle bacillus culture | 6 months | 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. |
| Fecal microbiome analysis | 6 months | The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter. |
| Assessment of immune function | 6 months | Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic γδT cells . |
Countries
China
Contacts
Primary ContactZhinan Yin, Ph.D.
Backup ContactYangzhe Wu, Ph.D.
Outcome results
None listed