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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030612
Receipt No. R000034895
Scientific Title A multi-center clinical trial of tolerance induction using autologous regulatory T cells in liver transplantation
Date of disclosure of the study information 2018/01/01
Last modified on 2019/08/20

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Basic information
Public title A multi-center clinical trial of tolerance induction using autologous regulatory T cells in liver transplantation
Acronym Treg multicenter clinical trial
Scientific Title A multi-center clinical trial of tolerance induction using autologous regulatory T cells in liver transplantation
Scientific Title:Acronym Treg multicenter clinical trial
Region
Japan

Condition
Condition End-stage liver failure patients eligible for liver transplantation
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To induce tolerance by infusing autologous donor antigen-specific regulatory T cells, generated ex-vivo from peripheral blood mononuclear cells, in living donor liver transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Immunosuppressive drug free rate at 30-month after liver transplantation
Key secondary outcomes 1.Amount of immunosuppressive drugs at 1, 2, 3, 4 and 5 years after liver transplantation
2.Drug free interval time after complete cessation of immunosuppressive drugs
3.Successful rate of immunosuppressive drug withdrawal at 30-month after liver transplantation by age
4.Safety of autologous regulatory T cell infusion
5.Safety of leukopheresis

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 The liver transplant recipient is given cyclophosphamide (40 mg/kg, iv) on postoperative days (POD) 5, and ex-vivo generated regulatory T cells on POD 13. Postoperative immunosuppression is with conventioal method. The immunosuppressant is reduced to 3/4 daily dose of the twice daily dose at 6 months, which is reduced to 3 times/week, 2 times/ week and 1 time/week every 3 months after confirming normal graft function and liver biopsy. The immunosuppressant is completely discontinued by 18 months after transplantation.
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. A case considered to have eligibility for liver transplantation by the specialists (liver transplant surgeons, physicians, anesthesiologists, radiologists, psychiatrists and pathologists) at the associated institutions
2. A case who is approved for liver transplantation by the medical IRB at the associated institutions
3. A patient over 20 years old. Each institute determine the upper limit of age.
4. A patient who receives informed consent and is well-understood for this protocol and given a consent in writing voluntarily
Donor
1. A case considered to have eligibility for liver transplantation donor by the specialists (liver transplant surgeons, physicians, anesthesiologists, radiologists, psychiatrists and pathologists) at the associated institutions
2. A case who is approved for liver transplantation donor by the medical IRB at the associated institutions
3. Platelet >= 100x103/micro L and Hb >= 12.0 g/dL
4. A donor who receives informed consent and is well-understood for this protocol and given a consent in writing voluntarily
Key exclusion criteria Recipient
1. A person who has no recognition capacity
2. A person who is judged inadequate for the protocol due to the following past history or ongoing infections
1) Bacterial infection such as Treponema pallidum, Neisseria gonorrhea or Mycobacterium tuberculosis
2) Sepsis
3) Malignant diseases (except for hepatocellular carcinoma)
4) Severe metabolic diseases
5) Collagen disease or hematological disorders
6) Transmissible spongiform encephalopathy or dementia
7) A specific hereditary disease or associated familial history
8) Human immunodeficiency virus infection
9) Human T-cell leukemia virus type 1 infection
10) Human parvovirus B19 infection
11) Active infection such as Cytomegalovirus, Epstein-Barr virus or West Nile virus
3. A person
1) with systolic blood pressure under 90 mmHg or over 180 mmHg,
2) with diastolic blood pressure under 50 mmHg or over 100 mmHg
4. A person considered ineligible due to some medical reasons by principal investigator or co-researchers

Donor
1. A donor who has no recognition capacity
2. A donor who is judged inadequate for the protocol due to the following past history or ongoing infections
1) Bacterial infection such as Treponema pallidum, Neisseria gonorrhea or Mycobacterium tuberculosis
2) Sepsis
3) Malignant diseases
4) Severe metabolic diseases
5) Collagen disease or hematological disorders
6) Liver diseases
7) Transmissible spongiform encephalopathy or dementia
8) A specific hereditary disease or associated familial history
9) HBV infection
10) HCV infection
11) Human immunodeficiency virus infection
9) Human T-cell leukemia virus type 1 infection
10) Human parvovirus B19 infection
11) Active infection such as Cytomegalovirus, Epstein-Barr virus or West Nile virus
3. A donor
1) with systolic blood pressure under 90 mmHg or over 180 mmHg,
2) with diastolic blood pressure under 50 mmHg or over 100 mmHg
4. A person considered ineligible due to some medical reasons by principal investigator or co-researchers
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akinobu Taketomi
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterological Surgery I
Zip code
Address N-14, W-5, Kita-ku, Sapporo 060-8648, Japan
TEL 011-706-5927
Email taketomi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akinobu Taketomi
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterological Surgery I
Zip code
Address N-14, W-5, Kita-ku, Sapporo 060-8648, Japan
TEL 011-706-5927
Homepage URL
Email taketomi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2018 Year 01 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
2018 Year 01 Month 18 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2023 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 28 Day
Last modified on
2019 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034895

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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