Disease of the BloodNCT05560217
Collection of Peripheral Blood Mononuclear Cells From Healthy Subjects
An observational study of Disease of the Blood, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
In accordance with the selection criteria, component blood collection will be carried out and peripheral blood mononuclear cells will be isolated, cryopreserved and in vitro culture of peripheral blood mononuclear cells. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Disease of the Blood
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2022to 10 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Regardless of race and nationality, healthy subjects aged between 18 and 40 years old (including the tipping point), who have not previously donated blood.
Who may be able to join
- aged 18-40, regardless of nationalities, and had no adverse reactions in blood donation;
- Weight: male≥50kg, female≥45kg, and 18.5kg/m2≤BMI≤30kg/m2 (BMI =weight（kg）÷height（m）2)；
- Blood pressure:
- 12.0Kpa（90mmHg）≤systolic pressure<18.7Kpa（140mmHg） 8.0Kpa（60mmHg）≤diastolic pressure<12.0Kpa（90mmHg）； Pulse rate: 60 beats/ min ~ 100 beats/ min, the athlete with high-level stamina≥50 beats/ min, normal and tidy rhythm.
- Body temperature:36.3-37.2℃;
- Generally in good condition: no impairment of major organs, including heart, lung, liver, and kidney, no serious or uncontrolled infections, and no history of severe mental illness;
- The clinical lab tests must meet the following standards:
- Blood routine, blood biochemistry, normal or abnormal liver and kidney function have no clinical significance; Normal testing of coagulation function; Negative for antibody to Hepatitis A Virus (HAV-IgM); Negative for Hepatitis B Virus Surface Antigen (HBsAg); Negative for antibody to Hepatitis C Virus (HCV); Negative for antibody to Human Immunodeficiency Virus (HIV-1 and HIV-2); Negative for Syphilis; Negative for DNA to Epstein-Barr Virus (EBV). Negative for DNA to cytomegalovirus (CMV) . Negative for DNA to B19. Negative for Human T Lymphocytic leukemia Virus (HTLV).
Who cannot join
- You have diseases in respiratory, circulatory, digestive, urinary, blood, immune, endocrine system or metabolic disorders;
- You have neurological diseases, mental diseases, Creutzfeldt-Jakob disease and have a family medical history or those who have received treatment with tissues or tissue derivatives that may be infected by Creutzfeldt-Jakob pathogen;
- You have chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- You have allergic diseases or frequent relapse;
- You have/had malignant tumors or benign tumors cause health problems;
- You have an infectious disease, a carrier of an infectious disease, a suspected infectious disease;
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- You have allogeneic tissue organ graft recipients.
- You have undergone the removal of important internal organs such as the stomach, kidneys, spleen, lungs and so on;
- Those who have caused the recipient to have infectious diseases related to blood transfusion.
- You have had minor surgery within 3 months, including appendectomy, eye surgery, etc.; major surgery within 1 year, such as: surgical treatment of gynecological benign tumor, superficial benign tumor, etc.;
- Women in pregnancy or had a miscarriage within 6 months, or post partum and in lactation within 1 year;
- Recovered from Upper respiratory tract infection no longer than one week, or from pneumonia no longer than three months;
- Recovered from Acute pyelonephritis no longer than 3 months, or within the attack period of the urinary tract stones;
- Injuries caused by or wounds contaminated by devices/apparatuses contaminated by blood or tissue fluid or tattooed within one year;
- You have received whole blood and blood component transfusion within 1 year;
- You have got the last vaccination of live attenuated vaccines within 2 weeks including measles, parotitis, or infantile paralysis, or got the last vaccination of live attenuated vaccines within 4 weeks including Rubella Vaccine, Rabies Vaccine for Human Use, Japanese Encephalitis Live Vaccine;
- You have accepted last immunization of Rabies Vaccine for Human Use after being bitten by an animal within 1 year;
- You have received the last vaccination of antitoxin or immune serum injection within 4 weeks, or got the last vaccination of hepatitis B human immunoglobulin within 1 year;
- You have been in a clinical trial within 6 months;
- You have clinical trial records within 3 months for the donation of WBC, plasma and platelet;
- You are evaluated by Investigator s as an unsuitable participant for this research.
About this study
Official title: a Study That Collection of Peripheral Blood Mononuclear Cells From Healthy Subjects
In accordance with the selection criteria, component blood collection will be carried out and peripheral blood mononuclear cells will be isolated, cryopreserved and in vitro culture of peripheral blood mononuclear cells. Cultivating cells under normal culture conditions or potential drug molecule treatment, observing and recording key parameters such as cell viability, proliferation, apoptosis and functional gene expression, will also provide an important reference for the production of CAR-T cell drugs.
Read the detailed description
aged 18-40, regardless of nationalities, and had no adverse reactions in blood donation; Weight: male≥50kg, female≥45kg, and 18.5kg/m2≤BMI≤30kg/m2 (BMI =weight（kg）÷height（m）2)；
Blood pressure:
12.0Kpa（90mmHg）≤systolic pressure<18.7Kpa（140mmHg） 8.0Kpa（60mmHg）≤diastolic pressure<12.0Kpa（90mmHg）； Pulse rate: 60 beats/ min ~ 100 beats/ min, the athlete with high-level stamina≥50 beats/ min, normal and tidy rhythm.
Body temperature:36.3-37.2℃; Generally in good condition: no impairment of major organs, including heart, lung, liver, and kidney, no serious or uncontrolled infections, and no history of severe mental illness;
The clinical lab tests must meet the following standards:
Blood routine, blood biochemistry, normal or abnormal liver and kidney function have no clinical significance; Normal testing of coagulation function; Negative for antibody to Hepatitis A Virus (HAV-IgM); Negative for Hepatitis B Virus Surface Antigen (HBsAg); Negative for antibody to Hepatitis C Virus (HCV); Negative for antibody to Human Immunodeficiency Virus (HIV-1 and HIV-2); Negative for Syphilis; Negative for DNA to Epstein-Barr Virus (EBV). Negative for DNA to cytomegalovirus (CMV) . Negative for DNA to B19. Negative for Human T Lymphocytic leukemia Virus (HTLV).
- Conditions
- Disease of the Blood
- Medical subject headings
- Hematologic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory research and process development of immunocytotherapy-related products.
Cultured cells under normal culture conditions or under the treatment of potential drug molecules, observe and record cell viability, proliferation, apoptosis, and functional expression.
Measured: September10 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start10 Oct 2022 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease of the BloodStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560217
- Sponsor's protocol ID
- SYSKY-2022-115-02
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Study That Collection of Peripheral Blood Mononuclear Cells From Healthy Subjects
- ClinicalTrials.gov ID
- NCT05560217
- Acronym / sponsor ID
- SYSKY-2022-115-02
- Conditions
- Disease of the Blood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In accordance with the selection criteria, component blood collection will be carried out and peripheral blood mononuclear cells will be isolated, cryopreserved and in vitro culture of peripheral blood mononuclear cells. Cultivating cells under normal culture conditions or potential drug molecule treatment, observing and recording key parameters such as cell viability, proliferation, apoptosis and functional gene expression, will also provide an important reference for the production of CAR-T cell drugs.
Detailed description
aged 18-40, regardless of nationalities, and had no adverse reactions in blood donation; Weight: male≥50kg, female≥45kg, and 18.5kg/m2≤BMI≤30kg/m2 (BMI =weight（kg）÷height（m）2)；
Blood pressure:
12.0Kpa（90mmHg）≤systolic pressure<18.7Kpa（140mmHg） 8.0Kpa（60mmHg）≤diastolic pressure<12.0Kpa（90mmHg）； Pulse rate: 60 beats/ min ~ 100 beats/ min, the athlete with high-level stamina≥50 beats/ min, normal and tidy rhythm.
Body temperature:36.3-37.2℃; Generally in good condition: no impairment of major organs, including heart, lung, liver, and kidney, no serious or uncontrolled infections, and no history of severe mental illness;
The clinical lab tests must meet the following standards:
Blood routine, blood biochemistry, normal or abnormal liver and kidney function have no clinical significance; Normal testing of coagulation function; Negative for antibody to Hepatitis A Virus (HAV-IgM); Negative for Hepatitis B Virus Surface Antigen (HBsAg); Negative for antibody to Hepatitis C Virus (HCV); Negative for antibody to Human Immunodeficiency Virus (HIV-1 and HIV-2); Negative for Syphilis; Negative for DNA to Epstein-Barr Virus (EBV). Negative for DNA to cytomegalovirus (CMV) . Negative for DNA to B19. Negative for Human T Lymphocytic leukemia Virus (HTLV).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Regardless of race and nationality, healthy subjects aged between 18 and 40 years old (including the tipping point), who have not previously donated blood.
Key inclusion criteria (8 listed)
- aged 18-40, regardless of nationalities, and had no adverse reactions in blood donation;
- Weight: male≥50kg, female≥45kg, and 18.5kg/m2≤BMI≤30kg/m2 (BMI =weight（kg）÷height（m）2)；
- Blood pressure:
- 12.0Kpa（90mmHg）≤systolic pressure<18.7Kpa（140mmHg） 8.0Kpa（60mmHg）≤diastolic pressure<12.0Kpa（90mmHg）； Pulse rate: 60 beats/ min ~ 100 beats/ min, the athlete with high-level stamina≥50 beats/ min, normal and tidy rhythm.
- Body temperature:36.3-37.2℃;
Key exclusion criteria (21 listed)
- You have diseases in respiratory, circulatory, digestive, urinary, blood, immune, endocrine system or metabolic disorders;
- You have neurological diseases, mental diseases, Creutzfeldt-Jakob disease and have a family medical history or those who have received treatment with tissues or tissue derivatives that may be infected by Creutzfeldt-Jakob pathogen;
- You have chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
- You have allergic diseases or frequent relapse;
- You have/had malignant tumors or benign tumors cause health problems;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exploratory research and process development of immunocytotherapy-related products.
Time frame: September10 2025
Cultured cells under normal culture conditions or under the treatment of potential drug molecules, observe and record cell viability, proliferation, apoptosis, and functional expression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease of the Blood, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory research and process development of immunocytotherapy-related products. (time frame: September10 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.