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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015789
Receipt No. R000018372
Scientific Title Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation
Date of disclosure of the study information 2015/11/29
Last modified on 2015/07/02

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Basic information
Public title Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation
Acronym Operational tolerance by a Treg therapy in LDLT
Scientific Title Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation
Scientific Title:Acronym Operational tolerance by a Treg therapy in LDLT
Region
Japan

Condition
Condition non-compenzated liver cirrhosis(HBV,HCV, alcoholic, etc), primary biliary cirrhosis (PBC), primary screlosing cholangitis (PSC), hepatocellular carcinoma (HCC within Milan criteria), non-alcoholic steatohepatitis (NASH), others
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To generate regulatory T cells, recipient lymphocytes collected before LDLT were co-cultured for 2 weeks with irradiated donor lymphocytes under the presence of anti-CD80/86 monoclonal antibodies. The cultured cells were intravinously given to the recipients on postoperative days 13 to evaluate the safety and the efficacy in reduction and discontinuation of immunosuppressants by the cell therapy.
Basic objectives2 Others
Basic objectives -Others To evaluate quantitative and functional changes (MLR) of Treg during drug weaning anf after discontinuation, along with immunopathological determination of scheduled-liver biopsies.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 1.Safety
Immediate systemic changes (blood pressure, pulse, respiration, fever, et al), and intermediate and long-term effect on infection, de-novo malignancy, immune diseases, et al.
2.Efficacy:
Liver function (ALT/AST/T-Bil/g-GTP, et al) and pathological changes (rejection/cell infiltrate/biliary changes/vascular damages, etal) of protocol-liver biopsies.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 The patient is given cyclophosphamide (40mg/kg,iv) on postoperative days (POD) 5, and ex-vivo generated regulatory T cells on POD 13. Postoperative immunosuppression is with comventioal method. Tke 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
18 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. A case who is approved by the Tranplantation Evaluation Committee and the IRB at Hokkaidou University
2.Recipient; 1). paitent suffering from end-stage liver disease that is indicated for liver transplantation for cure, 2). Patient who understands the protocol with a written informed concent
3. Donor; 1).Within 6 degree relatives 2).Donor who understands the protocol with a written informed concent, 3). 18 years old and more
Key exclusion criteria 1.Recipient; 1).extrahepatic malignancy,
2). extrahepatic infection or sepsis, 3)pregnant woman, 4).sever cardio-pulmonary disease, 5). patients who are regarded as inadequate for the study by investigators
2.Donor; 1). Those with with abnormality or inadequacy in the liver as a. functional (fatty liver, autoimmune liver disease, et al), b. morhological (anomaly of hepatic artery, kepatic vein, portal vein or biliary tract), c.too small graft or remnant liver for transplantation, 2).
with malignanct or infection, 3). with scychological inadequacy 4). beyond 6 degree relatives
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Todo
Organization Hokkaidou Universitu Graduate School of Medicine
Division name Professor Emeritus
Zip code
Address W-5,N-14,Kita-ku, Sapporo 060-8638, Japan
TEL 011-706-7062
Email stodo@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichirou Yamashita
Organization Hokkaidou Graduate School of Medicine
Division name Department of Organ Transplantation
Zip code
Address W-5,N-14,Kita-ku, Sapporo 060-8638, Japan
TEL 011-706-7062
Homepage URL
Email kenchan@med.hokudai.ac.jp

Sponsor
Institute Traslational Research and Clinical Trial Center
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Welfare and Labour (No.22130701)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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 、北海道大学病院

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 29 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
2011 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 29 Day
Last modified on
2015 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018372

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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