Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01165762
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2010-07-13
Brief Title:
Combined Blood Stem Cell and Kidney Transplant of One Haplotype Match Living Donor Pairs
Sponsor:
Everett Meyer
Organization:
Stanford University
Study Overview
Official Title:
Total Lymphoid Irradiation Anti-Thymocyte Globulin and Purified Donor CD34 and T-cell Transfusion in HLA Haplotype Match Living Donor Kidney Transplantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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 donor stem cells given after a living related one Haplotype match kidney transplantation will change the immune system such that immunosuppressive drugs can be completely withdrawn
Detailed Description:
The goal of this study is for the recipients of a living related kidney transplant of one HLA haplotype to be withdrawn of immunosuppressive medication and become tolerant to their kidney graft The recipient will receive a conditioning regimen composed of low dose radiation to the lymphoid tissue total lymphoid irradiation TLI and anti-thymocyte globulin ATG at the time of transplant They will then be infused with purified stem cell and T-cell from their kidney donors 2 weeks after the transplant to try to achieve mixed chimerism of their white blood cells with the donor the recipient would have a mixture some of the with blood cells of the donor and theirs in their blood The kidney donor has to provide peripheral stem cell 6-8 weeks before kidney donation It is an outpatient procedure done using peripheral veins after treatment with G-CSF filgrastimImmunosuppressive medication will be decreased gradually and possibly stopped by 1 12 year after the transplantation if the recipient meets withdrawing criteria persistence of mixed chimerism more than 18 months no episode of rejection and no rejection on surveillance kidney biopsy Potential candidates need to be approved for kidney transplant and available for close follow-up at Stanford University Medical Center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 | NIH | None | httpsreporternihgovquickSearchP01HL075462 |