A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for the Development of Allogeneic Cellular Immunotherapy Products
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Collection of Peripheral Blood Mononuclear Cells by Means of Apheresis
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- the number of PBMC
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and development of allogeneic cellular immunotherapy products.
Detailed Description
The study is a single-center study. 1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled. 2. Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Investigators
WEI XU
Chief Physician of hematology department
The First Affiliated Hospital with Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years and ≤ 40 years, male or female;
- •Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤ 30;
- •Healthy volunteers who signed informed consent form.
Exclusion Criteria
- •Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders;
- •Those 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;
- •Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- •Those with known allergic diseases or recurrent allergies;
- •Those with known malignant tumors or health-affecting benign tumors;
- •Two or more physical examination results of blood pressure have shown (except for white coat hypertension): systolic blood pressure \< 90 or ≥ 140mmHg, or diastolic blood pressure \< 60 or ≥ 90 mmHg, or pulse pressure difference \< 30 mmHg, heart rate: \< 60 beats/min or \>100 beats/min;
- •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;
- •lymphocyte subsets （lymphocyte proportion、CD3+、CD3+CD4+、CD3+CD8+、CD3-CD16+CD56+、CD19+）Abnormal detection and clinical significance;
- •Those 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;
- •Recipients of allogeneic tissue and organ transplants;
Outcomes
Primary Outcomes
the number of PBMC
Time Frame: two year