JPRN-jRCT2073200067进行中（未招募）1 期
Phase I/II Study to Evaluate the Safety and Efficacy of JB-101(Induced T Cell With Suppressing Functions), to Induce Operational Tolerance in Living Donor Liver Transplantation. - Induction of Transplant Tolerance in LDLT Via iTS
chida Koichiro0 个研究点目标入组 10 人开始时间: 2020年12月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •(1) Recipient
- •1) Patients who have given written informed consent to participate in the clinical trial.
- •2) Male or Female patients aged between 20 and 80 years old at the time of obtaining informed consent.
- •3) Patients who have been approved or will be approved for living-donor liver transplantation at the Medical Ethics Committee or equivalent organization established by the institution.
- •1) Patients who are healthy physically and psychologically and willing to donate organs voluntarily.
- •2) Patients who have given written informed consent to participate in the clinical trial.
- •3) Relative within the second degree of relationship or partner. (Acceptable degree conforms eligibility criteria of the institution.)
- •4) Male or Female patients aged between 20 and 65 years old at the time of obtaining informed consent.
- •5) Patients who match or adapt to recipients blood type.
- •6) Patients who have been approved or will be approved for living-donor liver transplantation at the Medical Ethics Committee or equivalent organization established by the institution.
- •7) Patients who are tolerable to vessel blood access for apheresis or will be obtained informed consent for catheter insertion (Neck or Groin).
排除标准
- •(1) Recipient
- •1) Patients who have clinical findings of active infection at the time of screening.
- •2) Patients who meet the following criteria at the time of screening.
- •SBP 90 or >=180 mmHg
- •DBP <50 or >= 100 mmHg
- •3) Patients who have following complications at the time of screening. (Previous medical history is acceptable.)
- •- Severe cardiac disease; Heart failure, Myocardial infarction, Myocarditis
- •- The hepatitis fulminant of the hepatic failure state.
- •- Renal disease; Nephrotic syndrome, Renal failure (acute and chronic), Uremia, Hydronephrosis
- •- Malignant neoplasm(Hepatocellular carcinoma is acceptable.)
- •- Immunodeficiency
- •4)Female who are pregnant (patients with a positive pregnancy test at screening) or are lactating during the study period. Female and male who do not agree to adequate contraception during the study period.
- •5) Patients who have used unapproved drugs, medical device or regenerative medical product in other clinical trial within 3 months before informed consent of the study.
- •6)Patients who have previous medical history of the risk factor for Torsades de pointes as follows.
- •- Heart failure, Hypokalemia, Family medical history of long QT syndrome; Parent, sibling, child
- •7) Patients who have hypersensitivity to the ingredients of Cyclophosphamide.
- •8) Patients who have hypersensitivity to the biological materials of investigational products; Fetal bovine serum, Ingredient derived from a rodent and human serum albumin.
- •9) Patients who have hypersensitivity to the ingredients of G-CSF.
- •10) Patients who are judged not to be appropriate in the study by principal investigators or sub-investigators.
- •1) Patients who have following disease or state.
- •1.HIV antibody positive 2.HBs antigen positive 3.Creutzfeldt-Jakob disease
- •2) Patients who have clinical findings of active infection at the time of screening.
- •3) Patients who meet the following laboratory values at the time of screening.
- •1.Platelet < 100*10^3/uL 2.Hemoglobin < 12.0 g/dL
- •4) Patients who meet the following criteria at the time of screening.
- •SBP <90 or >=180 mmHg
- •DBP <50 or >= 100 mmHg
- •5) Patients who have following complications at the time of screening. (Previous medical history is acceptable)
- •- Severe cardiac disease; Heart failure, Myocardial infarction, Myocarditis
- •- The hepatitis fulminant of the hepatic failure state.
- •- Renal disease; Nephrotic syndrome, Renal failure (acute and chronic), Uremia, Hydronephrosis
- •6) Female who are pregnant (patients with a positive pregnancy test at screening) or are lactating during the study period.
- •7) Patients who have used unapproved drugs, medical device or regenerative medical product in other clinical trial within 3 months before informed consent of the study.
- •8) Patients who have previous medical history of the risk factor for Torsades de pointes as follows.
- •- Heart failure, Hypokalemia, Family medical history of long QT syndrome; Parent, sibling, child
- •9) Patients who are judged not to be appropriate in the study by principal investigators or sub-investigators.
研究者
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