End-stage liver failure patients eligible for liver transplantation
Conditions
Interventions
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 conve
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunosuppressive drug free rate at 30-month after liver transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactAkinobu Taketomi
Hokkaido University Graduate School of Medicine Department of Gastroenterological Surgery I
Outcome results
None listed