Exploring the Effectiveness and Factors Affecting the Collection of Single Nucleated Cells From Different Volunteers

Not yet recruiting

• Conditions: Observational Study

• Registration Number: NCT06361602
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

1. 80 cases of healthy donors were subjected to peripheral blood single nucleated cells (PBMC) collection and analyzed the effects of age, body mass index (BMI), blood routine indexes before collection, collection of circulating blood volume, volume of processed blood and the number of circulations, etc., on the PBMC obtained from both men and women, and explored the effects of PBMC collection in different volunteers and the factors affecting the collection. and the influencing factors.

2. The data obtained will provide a reference for the MNC threshold for the subsequent clinical trials of immunocell therapy in hospitals.

3. From the screening of volunteers, PBMC collection and transportation conditions and other specific details of the operation, risk assessment and the establishment of a safe operation standard process, for the hospital to carry out subsequent clinical trials of immune cell therapy to provide an effective reference.

Detailed Description

1. Nationality is not limited, age is 18-55 years old (including boundary value), gender is not limited;

2. Body weight: male ≥ 50kg, female ≥ 45kg and 18.5kg/m2 ≤ BMI ≤ 30kg/m2 (BMI, body mass index = weight (kg) ÷ height (m)2);

3. Blood pressure:

12.0Kpa (90mmHg)≤systolic blood pressure≤18.7Kpa (140mmHg) 8.0Kpa (60mmHg) ≤ diastolic blood pressure ≤ 12.0Kpa (90mmHg);

4. Pulse: 60 beats/min ≤ pulse ≤ 100 beats/min, ≥ 50 beats/min for high endurance athletes, or rhythmic abnormalities without clinical significance;

5. Ear temperature: 35.7 ≤ body temperature ≤ 37.5 ℃;

6. Good general condition of the body: no damage to vital organs such as heart, lungs, liver, kidneys, etc., no serious or uncontrolled infections, no history of serious mental disorders;

7. Clinical examination should fulfill the following criteria:

7.1 Hemoglobin (Hb) measurement is normal or abnormal without clinical significance; 7.2 White blood cell (WBC) measurement: (3.5-10) × 109/L; 7.3 Platelet count (PLT) determination normal or abnormal without clinical significance; 7.4 Neutrophil count (NEU) determination normal or abnormal without clinical significance; 7.5 Normal or abnormal liver and kidney function test indexes without clinical significance; 7.6 Normal or abnormal coagulation function without clinical significance; 7.7 Hepatitis B virus surface antigen (HBsAg) negative; 7.8 Hepatitis C virus antibody (HCV antibody) negative; 7.9 human immunodeficiency virus antibody (HIV-1 and HIV-2 antibody) negative; 7.10 Syphilis negative;

Study Timeline

• Study First Submitted: 2024-03-26
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Study Start: 2024-05-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exploring the effectiveness and factors affecting the collection of single nucleated cells from different volunteers	MAY 1, 2027	We collected peripheral blood single nucleated cells (PBMC) from 80 healthy donors and analyzed the effects of age, body mass index (BMI), pre-collection blood parameters, collection of circulating blood volume, volume of processed blood, and the number of circulations on the PBMC collected from both male and female donors, to explore the effects of different volunteers on the collection of PBMC and the factors affecting the collection of PBMC. The effect of PBMC collection in different volunteers and the influencing factors were investigated.