Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-03-13 @ 8:10 PM
Study NCT ID:
NCT05086003
Status:
RECRUITING
Last Update Posted:
2021-10-28
First Post:
2021-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs
Status:
RECRUITING
Status Verified Date:
2021-10
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:
Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: