Recruiting Blood Donor With Allogeneic Natural Killer Cell

NCT ID: NCT02716571

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-28
• Study Completion Date: 2017-07-27

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.

Conditions

Healthy Volunteers

Keywords

Healthy Subjects; Healthy Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy Donors

Healthy Donors will given white blood cell and plasma

Group Type: OTHER

Leukapheresis or Plasmapheresis

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jung-Hwan Yoon

Professor,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jung-Hwan Yoon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 23326467 (View on PubMed)

Other Identifiers

MG4101_HCC_Donor

Identifier Type: -

Identifier Source: org_study_id