Skip to content

Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Development of Cellular Immunotherapy Product

Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Development of Cellular Immunotherapy Product

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030396
Enrollment
Unknown
Registered
2020-03-01
Start date
2020-03-06
Completion date
Unknown
Last updated
2020-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematology

Interventions

Healthy Subjects:Apheresis

Sponsors

Zhaxin Hospital of Shanghai Zhaxin integrated hospital of traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Healthy people aged 18-40 with unlimited gender; 2. Weight: Male>=50 kg, female>=45 kg, BMI 18.5 to 30; 3. Healthy subjects will to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. People with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders; 2. People with known neurological diseases, mental illnesses, Creutzfeldt-Jakob disease and those with a family history, or those treated with tissue or tissue derivatives that may be derived from Creutzfeldt-Jakob infected people; 3. People with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases; 4. People with known allergic diseases or recurrent allergies; 5. People with known malignant tumors or health-affecting benign tumors; 6. Twice or more times of blood pressure measurement exhibit (except for white coat hypertension): systolic blood pressure =140mmHg, or diastolic blood pressure =90 mmHg, or pulse pressure difference 100 beats/min; 7. Laboratory tests: hemoglobin determination: male <120 g/L, female <115 g/L, or liver and kidney function is more than 1.5 times the upper limit of normal and clinically significant, or 12-lead ECG is abnormal and clinically significant, or abdominal B-mode ultrasound is abnormal and clinically significant, or chest X-ray is abnormal and clinically significant, and T cell detection of tuberculosis infection is over the limit or positive; 8. People with positive hepatitis B surface antigen or HBV DNA, or hepatitis B e antigen, or hepatitis C antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody; 9. Recipients of allogeneic tissue and organ transplants; 10. People received resection of vital internal organs such as stomach, kidney, spleen and lung; 11. People caused blood transfusion-associated infectious diseases; 12. People underwent minor surgery within less than 3 months, such as appendectomy and ophthalmic surgery; those who have undergone major surgery within less than 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors; 13. Women who are pregnant, or have an abortion within less than 6 months or have undergone less than 1 year after childbirth and lactation; 14. People with upper respiratory tract infection recovered for less than 1 week, or pneumonia has recovered for less than 3 months; 15. People with acute pyelonephritis has recovered for less than 3 months, or those with acute exacerbation of urinary calculi; 16. Those who have been injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or who have got a tattoo for less than 1 year; 17. People who received whole blood and blood component transfusion within 1 year; 18. People who received the last vaccination of live attenuated vaccines such as measles, mumps, or polio within 2 weeks, or the last vaccination of rubella live vaccine, human rabies vaccine, live attenuated Japanese encephalitis vaccine within 4 weeks; 19.People who received the last vaccination of rabies vaccines after being bitten by an animal within 1 year; 20.People who received the last vaccination of antitoxin or immune serum injection within 4 weeks, or those who received the last vaccination of hepatitis B human immunoglobulin injection within 1 year; 21.People who participated in clinical trials within 1 month; if they have used investigational drugs, they need to be discussed case by case; 22.Those who are considered by the investigator as unsuitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
routine blood test;

Countries

China

Contacts

Public ContactZhu Jun

Shanghai Zhaxin integrated hospital of traditional Chinese and Western Medicine

zhuj@bohuhealthcare.com+86 21-36561999-8020

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026