Ignite Creation Date:
2024-05-06 @ 8:26 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02730299
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-28
First Post:
2016-03-28
Brief Title:
Stem Cell Transplantation With NiCord Omidubicel vs Standard UCB in Patients With Leukemia Lymphoma and MDS
Sponsor:
Gamida Cell ltd
Organization:
Gamida Cell ltd
Study Overview
Official Title:
A Multicenter Randomized Phase III Registration Trial of Transplantation of NiCord Ex Vivo Expanded UCB-derived Stem and Progenitor Cells vs Unmanipulated UCB for Patients With Hematological Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 is an open-label controlled multicenter international Phase III randomized study of transplantation of NiCord versus transplantation of one or two unmanipulated unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia myelodysplastic syndrome chronic myeloid leukemia or lymphoma all with required disease features rendering them eligible for allogeneic transplantation
Detailed Description:
Successful blood and marrow transplantation BMT requires the infusion of a sufficient number of hematopoietic stemprogenitor cells HSPCs capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion
A major drawback of Umbilical Cord Blood UCB is the low stem cell dose available for transplantation compared to mobilized peripheral blood PB or bone marrow This low stem cell dose can compromise the chances of engraftment and contributes to delayed kinetics of neutrophil and platelet recovery as well as other transplant outcomes
The aim of ex vivo expansion of cord blood is to provide a graft with sufficient numbers of cells that have rapid and robust in vivo neutrophil and platelet producing potential to enable successful transplantation
NiCord is a stemprogenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of UCB NiCord utilizes the small molecule nicotinamide NAM as an epigenetic approach to inhibit differentiation and to increase the migration bone marrow BM homing and engraftment efficiency of Hematopoietic Progenitor Cells HPC expanded in ex vivo cultures The chief aim of the study is to compare the safety and efficacy of NiCord single ex-vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following conditioning therapy
A major drawback of Umbilical Cord Blood UCB is the low stem cell dose available for transplantation compared to mobilized peripheral blood PB or bone marrow This low stem cell dose can compromise the chances of engraftment and contributes to delayed kinetics of neutrophil and platelet recovery as well as other transplant outcomes
The aim of ex vivo expansion of cord blood is to provide a graft with sufficient numbers of cells that have rapid and robust in vivo neutrophil and platelet producing potential to enable successful transplantation
NiCord is a stemprogenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of UCB NiCord utilizes the small molecule nicotinamide NAM as an epigenetic approach to inhibit differentiation and to increase the migration bone marrow BM homing and engraftment efficiency of Hematopoietic Progenitor Cells HPC expanded in ex vivo cultures The chief aim of the study is to compare the safety and efficacy of NiCord single ex-vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following conditioning therapy
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