Collection of peripheral blood leukocytes for the development of immune cell therapy drugs
Conditions
Interventions
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Nationality is not limited, age is 18-45 years (inclusive of boundary values), gender is not allowed; 2.Weight: >= 50 kg for men, >= 45 kg for women and 18.5 kg / m^2 <= BMI <= 30 kg / m^2 (BMI, body mass index = weight (kg) ÷ height (m)^ 2); 3. Blood pressure and pulse test indicators are normal or not clinically meaningful; 4.Body temperature: forehead temperature 35.9-37.6 ° C; 5. Normal or abnormal chest CT had no clinical significance; 6. The results of blood HCG showed negative pregnancy; 7. The general condition is good: no damage to vital organs such as heart, lungs, liver, kidneys, no serious or uncontrolled infections, no history of serious mental disorders; 8. Clinical examinations must meet the following criteria: 8.1 Normal or abnormal markers of blood routine are not clinically significant; 8.2 Normal or abnormal indicators of liver and kidney function are not clinically significant; 8.3 Normal or abnormal clotting function is not clinically significant; 8.4 Normal or abnormal blood electrolytes and fasting blood sugar are not clinically significant 8.5 Hepatitis B virus (HBsAg) negative; 8.6 Hepatitis B virus e antibodies are negative; 8.7 Hepatitis B virus core antibodies are negative; 8.8 Hepatitis C virus antibody (HCV antibody) negative; 8.9 Negative for human immunodeficiency virus (HIV-1) antibodies; 8.10 TPPA was negative. 9. The subject personally consents to participate in the clinical trial and signs an informed consent form indicating that the subject understands the purpose and procedures of the trial and voluntarily participates in the trial.
Exclusion criteria
Exclusion criteria: 1. The following diseases are considered clinically significant by the researchers: 1.1 Diseases of the respiratory, circulatory, digestive, urinary, haematological, immune, endocrine system or metabolic disorders; Persons with a history of nervous system disorders, psychiatric disorders, Creutzfeldt-Jakob disease and family history, or who are treated with tissues or tissue derivatives that may be infected with Creutzfeldt-Jakob disease causative agent; 1.2 Have chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases; People with allergic diseases or recurrent allergies; 1.3 Persons with malignant tumors or benign tumors affecting health; 2. People who have undergone minor surgery for less than 3 months, such as appendix removal, eye surgery, etc.; People who have undergone major surgery for less than 1 year, such as: benign gynecologic tumors, and gastrointestinal malignancies after surgery; 3. A woman who is less than six months pregnant or after a miscarriage, or who has given birth and breastfeeding for less than one year; 4. Less than 1 week after recovery from upper respiratory tract infection, or less than 3 months after recovery from pneumonia; 5. A person whose acute renal prostatic nephritis has lasted less than 3 months, or whose urinary tract stones are onset; 6. A person who has been injured or contaminated by equipment contaminated with blood or tissue fluid, or who has been tattooed for less than 1 year; 7.1 Persons who have received an infusion of whole blood and blood components within a year; 8. Within 2 weeks of receiving the last attenuated live vaccination against measles, mumps or polio, or within 4 weeks of receiving the last attenuated live vaccination against rubella or gray matter of spinal cord; 9. Persons who have been vaccinated against rabies after being bitten by an animal within one year of their last immunization; 10 Persons who received anti-toxin or immune serum injections within 4 weeks of their last vaccination, or within 1 year of receiving human immunoglobulin for hepatitis B; Donors of white blood cell, plasmapheresis, platelets and whole blood; 12.Alcoholics or regular drinkers during the previous 3 days of the trial, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine); Or a person who is unwilling to stop drinking or using any alcoholic products during the trial; 13. Those who have smoked for more than 10 years or who smoke more than 20 cigarettes a day; 14. A drug user or a person with a history of drug use; 15. The researchers did not consider it appropriate to participate in this study. 16. Female subjects were delayed collection on the day of collection when they were menstruating (Note: admission criteria were not met during menstruation to participate in this study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| leukocyte count ;Red Blood Cell Count;Hemoglobin;Platelet Count; | — |
Countries
China
Contacts
Public ContactWu Jianlong
Shenzhen Second People's Hospital
Outcome results
None listed