UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019183 |
|---|---|
| Receipt number | R000022074 |
| Scientific Title | Adoptive immunotherapy using donor liver graft derived natural killer (NK) cells for preventing severe infection after liver transplantation |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2019/10/04 21:34:05 |
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Basic information
Public title
Adoptive immunotherapy using donor liver graft derived natural killer (NK) cells for preventing severe infection after liver transplantation
Acronym
Liver NK cell therapy for preventing infection after liver transplant
Scientific Title
Adoptive immunotherapy using donor liver graft derived natural killer (NK) cells for preventing severe infection after liver transplantation
Scientific Title:Acronym
Liver NK cell therapy for preventing infection after liver transplant
Region
| Japan |
Condition
Condition
decompensated liver cirrhosis patients who will receive liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to analyze the safety and efficacy of adoptive immunotherapy using donor liver derived natural killer (NK) cells for preventing severe infection after liver transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of blood stream infection during one month after liver transplantation
Key secondary outcomes
1. Overall survival (6 months, 1 and 3 years)
2. Effect on immunological reaponse after liver transplantation
3. Incidence of recurrence of hepatocellular carcinoma and de novo malignancy
4. Incidence of other infectious disease
5. Safety evaluation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Single infusion of donor liver graft derived NK cells to the recipient 3 days after liver trasplantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Recipient
1) decompensated liver cirrhotic patients who will receive liver transplantation
2) 20 years old or older
3) written informed consent from patients or legal guardian
Donor
1) healthy person who will receive living donor liver operation
2) 20 years old or older
3) written informed consent
Key exclusion criteria
1) patients who will receive re-transplantation
2) patients who will receive deceased donor liver transplantation
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ohdan |
Organization
Applied Life Sciences Institute of Biomedical and Health Sciences Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery
Zip code
734-8551
Address
1-2-3 Kasumi Minami-ku, Hiroshima city
TEL
082-257-5220
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Ohira |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
1-2-3 Kasumi Minami-ku, Hiroshima city
TEL
082-257-5222
Homepage URL
mohira@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Committee for Regenerative Medicine
Address
1-2-3 Kasumi, Minami-ku, Hiroshima city
Tel
082-257-5186
kasumi-kenkyu@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2019 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022074
