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Clinical Trial Summary

In accordance with the selection criteria, component blood collection will be carried out and peripheral blood mononuclear cells will be isolated, cryopreserved and in vitro culture of peripheral blood mononuclear cells. Cultivating cells under normal culture conditions or potential drug molecule treatment, observing and recording key parameters such as cell viability, proliferation, apoptosis and functional gene expression, will also provide an important reference for the production of CAR-T cell drugs.


Clinical Trial Description

aged 18-40, regardless of nationalities, and had no adverse reactions in blood donation; Weight: male≥50kg, female≥45kg, and 18.5kg/m2≤BMI≤30kg/m2 (BMI =weight(kg)÷height(m)2); Blood pressure: 12.0Kpa(90mmHg)≤systolic pressure<18.7Kpa(140mmHg) 8.0Kpa(60mmHg)≤diastolic pressure<12.0Kpa(90mmHg); Pulse rate: 60 beats/ min ~ 100 beats/ min, the athlete with high-level stamina≥50 beats/ min, normal and tidy rhythm. Body temperature:36.3-37.2℃; Generally in good condition: no impairment of major organs, including heart, lung, liver, and kidney, no serious or uncontrolled infections, and no history of severe mental illness; The clinical lab tests must meet the following standards: Blood routine, blood biochemistry, normal or abnormal liver and kidney function have no clinical significance; Normal testing of coagulation function; Negative for antibody to Hepatitis A Virus (HAV-IgM); Negative for Hepatitis B Virus Surface Antigen (HBsAg); Negative for antibody to Hepatitis C Virus (HCV); Negative for antibody to Human Immunodeficiency Virus (HIV-1 and HIV-2); Negative for Syphilis; Negative for DNA to Epstein-Barr Virus (EBV). Negative for DNA to cytomegalovirus (CMV) . Negative for DNA to B19. Negative for Human T Lymphocytic leukemia Virus (HTLV). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05560217
Study type Observational
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact
Status Not yet recruiting
Phase
Start date October 10, 2022
Completion date September 10, 2025