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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

No restriction on nationality, age 18-55 years old (including borderline value), no restriction on gender;

Body weight: Male ≥50kg, female ≥45kg and 18.5kg/m2≤BMI≤30kg/m2 (BMI=Body Mass Index (BMI) = Weight (kg)÷Height (m)2);

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

Ear temperature: 35.7 ≤ body temperature ≤ 37.5 ℃;

Disqualifiers

the following diseases considered clinically significant by the investigator: 1.1 Have respiratory, circulatory, gastrointestinal, urinary, hematologic, immunologic, endocrine system diseases or metabolic disorders; neurological disorders, psychiatric disorders, Creutzfeldt-Jakob disease, and those with a family history of the disease, or those who are receiving treatment with tissues or tissue derivatives that may have originated from infection with Creutzfeldt-Jakob pathogens; 1.2 Persons with chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases; persons with allergic diseases or recurrent allergic attacks; 1.3 persons with malignant tumors or benign tumors affecting health;

those who have not completed 3 months of minor surgery, such as appendectomy, ophthalmic surgery after healing, etc.; those who have not completed 1 year of major surgery, such as: benign gynecological tumors, gastrointestinal malignant tumors after surgery, etc;

Women during pregnancy, less than 6 months after abortion, and less than 1 year after delivery and breastfeeding;

Less than 1 week after recovering from upper respiratory tract infection or less than 3 months after recovering from pneumonia;

Trial population

Healthy volunteers of any nationality, aged 18-55 (including boundary values) and of any gender

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • inapplicable

    Other intervention

    inapplicable

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Exploring the effectiveness and factors affecting the collection of single nucleated cells from different volunteers

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.

Time frame
MAY 1, 2027

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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