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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
Sponsor:
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Leukapheresis or Plasmapheresis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Healthy Donors
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).





Primary Outcome Measures :
  1. Ex vivo expended Allogeneic Natural killer cells(MG4101) viability [ Time Frame: 21 days ]
  2. Purity of ex vivo expended Allogeneic Natural killer cells(MG4101) [ Time Frame: 21 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jung-Hwan Yoon, M.D., Ph.D. Seoul National University Hospital
Publications:
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Responsible Party: Jung-Hwan Yoon, Professor,, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02716571    
Other Study ID Numbers: MG4101_HCC_Donor
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Undecided
Keywords provided by Jung-Hwan Yoon, Seoul National University Hospital:
Healthy Subjects
Healthy Participants