Healthy Volunteers
Conditions
Keywords
Healthy Subjects, Healthy Participants
Brief summary
This study on manufacture of MG4101 (allogeneic natural killer cell) to use for Hepatocellular carcinoma(HCC) after Transarterial Chemoembolization(TACE) will be harvested WBC(white blood cell) and plasma from healthy donors, or plasma from healthy donors by leukapheresis or plasmapheresis procedure.
Detailed description
The purpose of this study is to manufacture MG4101 (allogeneic natural killer cell) which will be used for clinical trial in HCC after TACE. Manufacturing MG4101 involves WBC(white blood cell) and plasma harvesting from healthy donors. Another methodology for plasma harvesting can be performed through the leukapheresis procedure. Healthy donors were requested to visit the institution twice for receiving either leukapheresis or plasmapheresis procedure. During the screening, study participants (subjects) were given a written informed consent, which was written in accordance with the Declaration of Helsinki and regional laws. Following the screening, study participants (subjects) each received a questionnaire for medical examination and a preliminary examination to evaluate their suitability as donors. If the study subjects' test result is suitable for clinical study standards either leukapheresis or plateletpheresis process will be performed for the following three weeks. The MG4101 will be manufactured from harvesting WBC and plasma, under the conditions of both GMP(Good Manufacturing Practice) at Green Cross Lab Cell Corp. (Korea). Also, the resulting MG4101, will be cryopreserved for using clinical trial in HCC after TACE.
Interventions
OTHERLeukapheresis or Plasmapheresis
Leukapheresis: Donate 5x10\^9 white blood cells and 400 ml of plasma. Plasmapheresis: Donate 400ml of plasma. Donated white blood cell and plasma will be manufactured MG4101(allogeneic natural killer cell) to use for Hepatocellular carcinoma(HCC) patients after Transarterial Chemoembolization(TACE).
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male body weight must be over 50 ㎏, Female body weight must be over 45㎏, * Temperature less than 37.5 Celsius, * Systolic blood pressure greater than 90 and less than 180 ㎜Hg, * Diastolic blood pressure less than 100 ㎜Hg, * Heart rate between 50 to 100 beats per minute. * No abnormality in CBC(complete blood count) and PT/aPTT(prothrombin time /activated Partial Thromboplastin Time)Test * ALT(ALanine Transaminase) Less than 65IU/L * No history of bleeding and bleeding diathesis
Exclusion criteria
* Drinking more than 3 alcoholic drinks per week. * Under the 12.5g/dl hemoglobin (38% packed cell volume) * Positive tests for blood borne pathogens (HBV, HCV(Hepatitis C Virus), HIV, HTLV(human T lymphotropic virus)-I,II, syphilis, CMV(Cyto-Megalo-Virus), EBV(Epstein-Barr Virus)) * Person who falls short of health standards, such as a patient with an infectious disease or a patient who take medication, who is prescribed by Ordinance of the Ministry of Health and Welfare as unfit to donate blood. * Donor taking prescription medications other than those deemed allowable by the investigator. * Aspirin within prior 3 days * Ticlopidine within prior 2 weeks * Isotretinoin, Finasteride within prior 1 month * Dutasteride within prior 6 months * Hepatitis B immune globulin(HBIG), Placental Extract within prior 1 year * People vaccinate against Cholera, diphtheria, influenza, A hepatitis, B hepatitis, typhoid, poliomyelitis, Japanese encephalitis, tetanus, pertussis, Korean hemorrhagic fever, Bacillus anthracis, rabies virus cannot donate blood for 24 hours. * People vaccinate against measles, epidemic parotitis, yellow fever and administer Oral Polio-Vaccine, Oral Poliomyelitis Vaccine cannot donate blood for 2 weeks. * People vaccinate against rubella virus, varicella virus, BCG cannot donate blood for 1 month. * If female, pregnant or parturition or miscarriage within prior 6 months * Transfusion within prior 1 years * A Whole blood donation within prior 2 months. * A Plasmapheresis, a plateletpheresis and a 2 units plateletpheresis within the prior 14 days * A Leukapheresis within prior 72 hours * Having received more than 5 whole blood donation within prior 1 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ex vivo expended Allogeneic Natural killer cells(MG4101) viability | 21 days |
| Purity of ex vivo expended Allogeneic Natural killer cells(MG4101) | 21 days |
Countries
South Korea
Outcome results
None listed