CompletedNot Applicable

Recruiting Blood Donor With Allogeneic Natural Killer Cell

South Korea90 participantsStarted 2016-03-28

Plain-language 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.

Who can participate

Age range

20 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ex vivo expended Allogeneic Natural killer cells(MG4101) viability

Timeframe: 21 days

Purity of ex vivo expended Allogeneic Natural killer cells(MG4101)

Timeframe: 21 days

Trial details

NCT IDNCT02716571

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-02

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