Multi-drug Resistant Tuberculosis Clinical Trial
— MDR-TBOfficial title:
Clinical Study on Adoptive Treatment of Multidrug Resistant Pulmonary Tuberculosis With Allogeneic γδT Cells
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | December 31, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Shenzhen Third People's Hospital | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zhinan Yin, Ph.D. | Shenzhen Third People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Fecal microbiome analysis | The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter. | 6 months | |
Secondary | Assessment of immune function | Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic ?dT cells . | 6 months |
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