Recruiting Blood Donor With Allogeneic Natural Killer Cell
Recruiting Blood Donor With Allogeneic Natural Killer Cell
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.
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.
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