Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Junten Bio Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical trial is to examine the immunotolerance-inducing ability (effectiveness) of induced inhibitory T cells JB-101 in patients with living-donor liver transplantation using "whether or not operational tolerance is achieved" as an index.
And the safety of JB-101 will be evaluated.
This trial is a phase I / II, open-label, single-arm, multicenter clinical trial of JB-101, an inducible inhibitory T cell, in patients with end-stage liver failure who undergo living-donor liver transplantation.
The primary endpoint of efficacy is withdrawal from immunosuppressant by 78 weeks (up to 91 weeks) after liver transplantation, and then "whether or not operational tolerance is achieved".
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JB-101 | Experimental | induced T cell with suppressive function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JB-101 | Biological | induced T cell with suppressive function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of operational tolerance | Achievement of "Operational Tolerance" defined as no biopsy proven rejection diagnosed by Banff criteria for more than 52 weeks after withdrawal of immunosuppressive drugs post transplant | immunosuppressive drug cessation was maintained for at least 12 months |
Not provided
Not provided
Inclusion Criteria:
Patients with end-stage liver failure undergoing living-donor liver transplantation.
Subjects who are healthy physically and psychologically and willing to donate organs voluntarily.
Relative within the second degree of relationship or partner. (Acceptable degree conforms eligibility criteria of the institution.)
Exclusion Criteria:
Patients who have clinical findings of active infection.
Patients with advanced heart disease, fulminant hepatitis in liver failure, renal disease, malignant tumors and complications of immunodeficiency.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Koichiro Uchida, M.D.,Ph.D. | Juntendo University Advanced Research Institute for Health Science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juntendo University Hospital | Bunkyoku | Tokyo | Japan | |||
| Tokyo Women's Medical University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26773713 | Result | Todo S, Yamashita K, Goto R, Zaitsu M, Nagatsu A, Oura T, Watanabe M, Aoyagi T, Suzuki T, Shimamura T, Kamiyama T, Sato N, Sugita J, Hatanaka K, Bashuda H, Habu S, Demetris AJ, Okumura K. A pilot study of operational tolerance with a regulatory T-cell-based cell therapy in living donor liver transplantation. Hepatology. 2016 Aug;64(2):632-43. doi: 10.1002/hep.28459. Epub 2016 Mar 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Shinjuku |
| Tokyo |
| Japan |
| Hiroshima University Hospital | Hiroshima | Japan |
| Kyoto University Hospital | Kyoto | Japan |
| Nagasaki University Hospital | Nagasaki | Japan |