a Study That Collection of Peripheral Blood Mononuclear Cells From Healthy Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Disease of the Blood
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Enrollment
- 50
- Primary Endpoint
- Exploratory research and process development of immunocytotherapy-related products.
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 B
- •Negative for Human T Lymphocytic leukemia Virus (HTLV).
Exclusion Criteria
- •You have diseases in respiratory, circulatory, digestive, urinary, blood, immune, endocrine system or metabolic disorders;
- •You have neurological diseases, mental diseases, Creutzfeldt-Jakob disease and have a family medical history or those who have received treatment with tissues or tissue derivatives that may be infected by Creutzfeldt-Jakob pathogen;
- •You have chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- •You have allergic diseases or frequent relapse;
- •You have/had malignant tumors or benign tumors cause health problems;
- •You have an infectious disease, a carrier of an infectious disease, a suspected infectious disease;
- •You have allogeneic tissue organ graft recipients.
- •You have undergone the removal of important internal organs such as the stomach, kidneys, spleen, lungs and so on;
- •Those who have caused the recipient to have infectious diseases related to blood transfusion.
- •You have had minor surgery within 3 months, including appendectomy, eye surgery, etc.; major surgery within 1 year, such as: surgical treatment of gynecological benign tumor, superficial benign tumor, etc.;
Outcomes
Primary Outcomes
Exploratory research and process development of immunocytotherapy-related products.
Time Frame: September10 2025
Cultured cells under normal culture conditions or under the treatment of potential drug molecules, observe and record cell viability, proliferation, apoptosis, and functional expression.