Ignite Creation Date:
2024-05-06 @ 9:08 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02915406
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2017-08-16
First Post:
2016-09-23
Brief Title:
cliniMACs HUD for T Cell Depletion
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
cliniMACs HUD for T Cell Depletion
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2017-08
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 protocol is designed to enable access to related or unrelated CD34 cells manufactured using the CliniMACS Miltenyi under the HUD designation for patients needing T cell depleted allogeneic grafts for hematopoietic stem cell transplant HSCT This will include patients with inherited immunodeficiency disorders as well as patients with malignancies bone marrow failure and other rare diseases amenable to HSCT Finally patients with poor graft function and Graft Versus Host DiseaseGVHD after a previous HSCT may require a boost of T-cell depleted donor Peripheral Blood Stem Cell PBSCs or bone marrow cells that are CD34 selected using the CliniMACS device ENROLLMENT BY INVITATION ONLY
Detailed Description:
None
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