UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015789 |
|---|---|
| Receipt number | 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 10:18:10 |
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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
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
kenchan@med.hokudai.ac.jp
Sponsor or person
Institute
Traslational Research and Clinical Trial Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018372
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