Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03606746
Status:
WITHDRAWN
Last Update Posted:
2024-06-07
First Post:
2018-07-20
Brief Title:
Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch Living Donor Kidney Transplants
Sponsor:
Medeor Therapeutics Inc
Organization:
Medeor Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Prospective Multi-center Open-label Trial to Assess the Safety Efficacy of Cellular Immunotherapy With MDR-103 for Induction of Mixed Chimerism Immune Tolerance in Past Recipients of HLA Zero-mismatch LD Kidney Transplants
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen HLA-matched living donor kidney transplants
Detailed Description:
Currently patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney These medications carry substantial side effects In addition these medicines often do not completely control damage to the kidney from the recipients immune system ultimately causing the kidney to fail
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the past recipients immune system to accept the transplanted kidney without the concurrent need for long term use of immunosuppressive drugs
The purpose of the current Phase 2 study is to demonstrate the efficacy and safety of MDR-103 for the induction of transplant immune tolerance in a prospective multicenter clinical trial MDR-103 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function avert transplant kidney rejection and eliminate the cumulative and serious side effects associated with immunosuppressive drugs
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the past recipients immune system to accept the transplanted kidney without the concurrent need for long term use of immunosuppressive drugs
The purpose of the current Phase 2 study is to demonstrate the efficacy and safety of MDR-103 for the induction of transplant immune tolerance in a prospective multicenter clinical trial MDR-103 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function avert transplant kidney rejection and eliminate the cumulative and serious side effects associated with immunosuppressive drugs
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