Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497926
Status:
TERMINATED
Last Update Posted:
2023-10-11
First Post:
2007-07-06
Brief Title:
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
Sponsor:
Talaris Therapeutics Inc
Organization:
Talaris Therapeutics Inc
Study Overview
Official Title:
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
living donor kidney program terminated due to slow pace of phase 3 study enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An open-label study to assess the safety efficacy and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor
Detailed Description:
Research study which involves the use of a combination of an Enriched Hematopoietic Stem Cell Infusion stem cells produced by the bone marrow generate the cells that form the blood elements help fight infection and assist in clotting and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy The desired result of this study is to allow the body to develop tolerance to the transplanted kidney Tolerance means that the body would see the transplanted kidney as part of the patient and not try to get rid of or reject it To prevent rejection drugs called immunosuppressive agents must be taken on a daily basis The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications
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