Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03093844
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2017-03-22
Brief Title:
Haploidentical CD34 Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Safety and Efficacy of Miltenyi CliniMACS CD34 Reagent System for Transplant Protocol Utilizing Haploidentical CD34 Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders
Status:
RECRUITING
Status Verified Date:
2024-02
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 is a study to evaluate the safety and efficacy of Miltenyi CliniMACS CD34 Reagent System to promote engraftment of haploidentical CD34 selected cells combined with single unit umbilical cord blood transplant for treatment of high-risk hematologic disorders
Detailed Description:
In this clinical protocol the CliniMACS CD34 Reagent System will be used for processing hematopoietic progenitor cells collected by apheresis HPC Apheresis from an allogeneic HLA-haploidentical related donor to obtain a CD34 cell-enriched population for hematopoietic reconstitution The haploidentical donor will be mobilized by G-CSF and undergo one apheresis to collect CD34 stem cells The products will be cryopreserved until the time of transplantation Recipients with hematologic disorders who require transplant will receive a standard conditioning regimen and will receive an allograft on day 0 containing donor CD34 cells that have been positively selected and T-cell depleted following G-CSF mobilization combined with a single UCB unit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None