Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02258490
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-03-15
First Post:
2014-09-16
Brief Title:
Expanded Use of G-CSF Mobilized Donor CD34 Selected Cells for Allogeneic Transplantation
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Expanded Use of G-CSF Mobilized Donor CD34 Selected Cells for Allogeneic Transplantation to Recipients With Limited Donor Engraftment
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2022-02
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:
Allogeneic hematopoietic stem cell transplantation HSCT is an established form of treatment for hematological abnormalities Poor graft function occurs when there poor donor engraftment A second infusion of unselected donor hematopoietic stem cells HSC can result in improvement but can potentially increase the incidence of graft versus host disease Cluster of differentiation 34 CD34 selected stem cells depleted of T-cells is an attractive alternative for treatment of poor graft function as it may be associated with less Graft versus Host Disease GVHD and enhanced count recovery The investigators are using the Miltenyi CliniMACS device and CD34 cell selection reagents for the preparation of allogeneic hematopoietic progenitor cell HPC transplants for patients who have had prior stem cell transplants and require a stem cell boost from the original donor
Detailed Description:
This is a single-arm open label single institution compassionate study which will enroll patients who are marginally engrafted and transfusion andor growth factors dependent after allogeneic hematopoietic stem cell transplant HSCT regardless of the underlying disease for which the transplant was performed Study subjects will receive a booster infusion of CD34 cell selected and T-cell depleted G-CSF mobilized apheresis product from the original stem cell donor in order to improve engraftment The booster infusion will be administered without prior conditioning
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPIC-HPC001 | OTHER | Winship Cancer Institute | None |