Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03943238
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2019-05-07
Brief Title:
TLI TBI ATG Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Phase 1 Study of Total Lymphoid Irradiation Total Body Irradiation Anti-Thymocyte Globulin and Purified Donor CD34 T-cell and Recipient T Regulatory Cell Transfusion in Human Leukocyte Antigen Mismatched Living Donor Kidney Transplantation
Status:
RECRUITING
Status Verified Date:
2023-11
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:
This study will determine whether a preparatory regimen including total lymphoid irradiation TLI total body irradiation TBI anti-thymocyte globulin ATG and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells Tregs will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation
Detailed Description:
It has been demonstrated that hematopoietic mixed chimerism or the coexistence of both donor and recipient immune cells can lead to tolerance to the graft in absence of graft versus host disease GVHD The goal of this pilot study is to determine if recipients of living donor kidney transplant can be successfully withdraw from immunosuppressive drugs The patients will receive a preparatory regimen consisting of TLI and a low single dose of TBI and ATG following their kidney transplantation Two weeks later they will receive purified hematopoietic stem cells CD34 and Tcells that have been collected 6 weeks prior from their kidney donor Regulatory T cells Tregs that have been collected from the recipient prior to the transplantation and expanded in vitro will be infuse the following day to enhance the chance of engraftment of the donor bone marrow cells If chimerism develops and persists the immunosuppressive drug will be tapered and stop Mycophenolate mofetil MMF will be stopped 12 months after transplantation and if the chimerism remains stable tacrolimus will be stopped 6 months later The dose of Tregs will be escalated if the of donor chimerism is not at least 25 during the first 60 days
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