Ignite Creation Date:
2024-05-06 @ 2:15 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04260698
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-28
First Post:
2020-02-05
Brief Title:
Expanded Access of Omidubicel for Allogeneic Transplantation in Patients With Hematological Malignancies
Sponsor:
Gamida Cell ltd
Organization:
Gamida Cell ltd
Study Overview
Official Title:
An Open Label Expanded Access Study of Omidubicel for Allogeneic Transplantation in 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:
Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies
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
Omidubicel is a stemprogenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of umbilical cord blood Omidubicel 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 overall study objectives are to provide access to omidubicel for transplantation in patients with hematological malignancies and to collect additional safety and efficacy data
Omidubicel is a stemprogenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of umbilical cord blood Omidubicel 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 overall study objectives are to provide access to omidubicel for transplantation in patients with hematological malignancies and to collect additional safety and efficacy data
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