Clinical trial NCT02716571: Recruiting Blood Donor With Allogeneic Natural Killer Cell
Official title: Recruiting Blood Donor With Allogeneic Natural Killer Cell Which Will be Used for HCC After TACE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Healthy Subjects
Healthy Participants
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ex vivo expended Allogeneic Natural killer cells(MG4101) viability
timeFrame: 21 days
measure: Purity of ex vivo expended Allogeneic Natural killer cells(MG4101)
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung-Hwan Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim O, Lee Y, Chung H, Her JH, Kang SM, Jung MY, Min B, Shin H, Kim TM, Heo DS, Hwang YK, Shin EC. GMP-compliant, large-scale expanded allogeneic natural killer cells have potent cytolytic activity against cancer cells in vitro and in vivo. PLoS One. 2013;8(1):e53611. doi: 10.1371/journal.pone.0053611. Epub 2013 Jan 11.