Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06361602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Effectiveness and Factors Affecting the Collection of Single Nucleated Cells From Different Volunteers
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Study Overview
Official Title:
Exploring the Effectiveness and Factors Affecting the Collection of Single Nucleated Cells From Different Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYX-AN-01
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.
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;
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: