Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06047886
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-09-14
Brief Title:
CD34 Selection Using the Automated CliniMACS Prodigy
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature Therefore those patients are at increased risk of graft versus host disease and the infusion of a CD34 selected graft would reduce such a risk The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia However the use of the Prodigy would streamline the processing in terms of hands-off procedure allowing to provision of this product to the patients without strains on the cell therapy lab team This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions
Detailed Description:
Patients eligible to be treated on this status are status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function eg marrow cellularity reduced per age andor dropping donor chimerism with cytopenias andor platelets or red blood cells transfusion requirement
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