Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-26
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:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 185kgm2 BMI 30kgm2 BMI body mass index weight kg height m2
3 Blood pressure
120Kpa 90mmHgsystolic blood pressure187Kpa 140mmHg 80Kpa 60mmHg diastolic blood pressure 120Kpa 90mmHg
4 Pulse 60 beatsmin pulse 100 beatsmin 50 beatsmin for high endurance athletes or rhythmic abnormalities without clinical significance
5 Ear temperature 357 body temperature 375
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
71 Hemoglobin Hb measurement is normal or abnormal without clinical significance 72 White blood cell WBC measurement 35-10 109L 73 Platelet count PLT determination normal or abnormal without clinical significance 74 Neutrophil count NEU determination normal or abnormal without clinical significance 75 Normal or abnormal liver and kidney function test indexes without clinical significance 76 Normal or abnormal coagulation function without clinical significance 77 Hepatitis B virus surface antigen HBsAg negative 78 Hepatitis C virus antibody HCV antibody negative 79 human immunodeficiency virus antibody HIV-1 and HIV-2 antibody negative 710 Syphilis negative
2 Body weight male 50kg female 45kg and 185kgm2 BMI 30kgm2 BMI body mass index weight kg height m2
3 Blood pressure
120Kpa 90mmHgsystolic blood pressure187Kpa 140mmHg 80Kpa 60mmHg diastolic blood pressure 120Kpa 90mmHg
4 Pulse 60 beatsmin pulse 100 beatsmin 50 beatsmin for high endurance athletes or rhythmic abnormalities without clinical significance
5 Ear temperature 357 body temperature 375
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
71 Hemoglobin Hb measurement is normal or abnormal without clinical significance 72 White blood cell WBC measurement 35-10 109L 73 Platelet count PLT determination normal or abnormal without clinical significance 74 Neutrophil count NEU determination normal or abnormal without clinical significance 75 Normal or abnormal liver and kidney function test indexes without clinical significance 76 Normal or abnormal coagulation function without clinical significance 77 Hepatitis B virus surface antigen HBsAg negative 78 Hepatitis C virus antibody HCV antibody negative 79 human immunodeficiency virus antibody HIV-1 and HIV-2 antibody negative 710 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?:
None