Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319657
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-06-18
First Post:
2006-04-28
Brief Title:
Kidney and Blood Stem Cell Transplantation That Eliminates Requirement for Immunosuppressive Drugs
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Total Lymphoid Irradiation Anti-Thymocyte Globulin and Purified Donor CD34 and T-Cell Transfusion in HLA-Matched Living Donor Kidney Transplantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone Marrow Transplantation are enrolling patients into a research study to determine if blood stem cells injected after kidney transplantation in combination with lymphoid irradiation will change the immune system such that immunosuppressive drugs can be completely withdrawn Patients must have a healthy completely human leukocyte antigen HLA-matched brother or sister as the organ and stem cell donor
One to two months before kidney transplant surgery blood stem cells will be removed from the donor and the cells will be frozen After transplant surgery the recipient will receive radiation and anti-T cell antibody treatments for two weeks to prepare for injection of the stem cells The stem cells will be injected at the end of the two-week treatment If the stem cells persist in the recipient immunosuppressive drugs will be gradually reduced until they are withdrawn completely at least six months after transplantation Patients will be followed in the Stanford clinics for transplant patients Patients who live outside of the San Francisco Bay Area must remain near Stanford for six weeks after transplant surgery
One to two months before kidney transplant surgery blood stem cells will be removed from the donor and the cells will be frozen After transplant surgery the recipient will receive radiation and anti-T cell antibody treatments for two weeks to prepare for injection of the stem cells The stem cells will be injected at the end of the two-week treatment If the stem cells persist in the recipient immunosuppressive drugs will be gradually reduced until they are withdrawn completely at least six months after transplantation Patients will be followed in the Stanford clinics for transplant patients Patients who live outside of the San Francisco Bay Area must remain near Stanford for six weeks after transplant surgery
Detailed Description:
The purpose of this study is to determine the proportion of patients that can be withdrawn completely from immunosuppressive drugs while maintaining normal function of HLA-matched living related donor kidney transplants Fifteen participants will be conditioned with total lymphoid irradiation TLI and rabbit anti-thymocyte globulin ATG and given an infusion of donor mobilized blood mononuclear cells prior to transplantation
This is a single-center open-label study in adult renal transplant patients Fifteen patients will receive TLI ATG and an infusion of CD34 selected G-CSF mobilized blood cells combined with a fixed number 1x106 of CD3 T cells from the same mobilized blood cell source Patients will receive a one-month course of mycophenolate mofetil and a six to 12 month tapering course of cyclosporine that will be discontinued at six months At serial timepoints 1 graft function will be monitored 2 chimerism will be measured in recipient white blood cell subsets 3 mixed lymphocyte response MLR assays of peripheral blood mononuclear cells against donor and third party cells will be performed and 4 protocol biopsies of the graft will be obtained An attempt will be made to discontinue cyclosporine at six months if 1 chimerism is detectable for at least 180 days after CD34 and CD3 cell infusion 2 there is stable graft function without clinical rejection episodes and 3 there is lack of histologic rejection on protocol biopsies In the proposed study patients will be given a target dose of 8-10x106 CD34 cellskg and 1x106 CD3 cellskg because sustained chimerism may be necessary for sustained tolerance to the graft
This is a single-center open-label study in adult renal transplant patients Fifteen patients will receive TLI ATG and an infusion of CD34 selected G-CSF mobilized blood cells combined with a fixed number 1x106 of CD3 T cells from the same mobilized blood cell source Patients will receive a one-month course of mycophenolate mofetil and a six to 12 month tapering course of cyclosporine that will be discontinued at six months At serial timepoints 1 graft function will be monitored 2 chimerism will be measured in recipient white blood cell subsets 3 mixed lymphocyte response MLR assays of peripheral blood mononuclear cells against donor and third party cells will be performed and 4 protocol biopsies of the graft will be obtained An attempt will be made to discontinue cyclosporine at six months if 1 chimerism is detectable for at least 180 days after CD34 and CD3 cell infusion 2 there is stable graft function without clinical rejection episodes and 3 there is lack of histologic rejection on protocol biopsies In the proposed study patients will be given a target dose of 8-10x106 CD34 cellskg and 1x106 CD3 cellskg because sustained chimerism may be necessary for sustained tolerance to the graft
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01HL075462-02 | NIH | None | httpsreporternihgovquickSearchP01HL075462-02 |