Healthy VolunteersNCT02716571
Recruiting Blood Donor With Allogeneic Natural Killer Cell
A study testing Leukapheresis or Plasmapheresis in people with Healthy Volunteers, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Leukapheresis or Plasmapheresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2016to 27 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recruiting Blood Donor With Allogeneic Natural Killer Cell Which Will be Used for HCC After TACE
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.
Read the 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
- Being tested
- Leukapheresis or Plasmapheresis
- Keywords
- Healthy Subjects, Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukapheresis or PlasmapheresisOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Healthy Donors | Other | Healthy Donors will given white blood cell and plasma Receives: Other: Leukapheresis or Plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex vivo expended Allogeneic Natural killer cells(MG4101) viability
Measured: 21 days
Purity of ex vivo expended Allogeneic Natural killer cells(MG4101)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start28 Mar 2016
- Primary completion2 Jun 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Hwan Yoon, Seoul National University Hospital
- Investigators
- Jung-Hwan Yoon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716571
- Sponsor's protocol ID
- MG4101_HCC_Donor
- Status last verified
- Jul 2017
- First submitted
- 9 Mar 2016
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Undecided
Publications
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.
PubMed 23326467
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recruiting Blood Donor With Allogeneic Natural Killer Cell Which Will be Used for HCC After TACE
- ClinicalTrials.gov ID
- NCT02716571
- Acronym / sponsor ID
- MG4101_HCC_Donor
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Subjects, Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Mar 2016 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Donors | Other | Other: Leukapheresis or PlasmapheresisHealthy Donors will given white blood cell and plasma |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukapheresis or PlasmapheresisLeukapheresis: 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). | Other | Healthy Donors |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Background: PubMed 23326467Lim 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.
- Individual participant dataSharing planned: No. Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Hwan Yoon, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leukapheresis or Plasmapheresis in people with Healthy Volunteers, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ex vivo expended Allogeneic Natural killer cells(MG4101) viability (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02716571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.