Recruiting Blood Donor With Allogeneic Natural Killer Cell
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|ClinicalTrials.gov Identifier: NCT02716571|
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Other: Leukapheresis or Plasmapheresis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Recruiting Blood Donor With Allogeneic Natural Killer Cell Which Will be Used for HCC After TACE|
|Actual Study Start Date :||March 28, 2016|
|Actual Primary Completion Date :||June 2, 2017|
|Actual Study Completion Date :||July 27, 2017|
Healthy Donors will given white blood cell and plasma
Other: Leukapheresis 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).
- Ex vivo expended Allogeneic Natural killer cells(MG4101) viability [ Time Frame: 21 days ]
- Purity of ex vivo expended Allogeneic Natural killer cells(MG4101) [ Time Frame: 21 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716571
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 03080|
|Principal Investigator:||Jung-Hwan Yoon, M.D., Ph.D.||Seoul National University Hospital|