Healthy Volunteers Clinical Trial
Official title:
Recruiting Blood Donor With Allogeneic Natural Killer Cell Which Will be Used for HCC After TACE
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.
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