Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01856582
Status:
TERMINATED
Last Update Posted:
2019-11-22
First Post:
2013-05-15
Brief Title:
CD34 Stem Cell Infusion to Augment Graft Function
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Post Transplant CD34 Selected Stem Cell Infusion to Augment Graft Function in Children With Primary Immunodeficiency Diseases and Bone Marrow Failure Syndromes
Status:
TERMINATED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CliniMACS CD34 Reagent System was FDA approved for clinical use therefore patients were treated clinically
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if infusing additional special donor cells will help to improve graft or immune function in previously transplanted children with immune deficiencies and bone marrow failures
Detailed Description:
The purpose of this study is to investigate the usefulness of infusing purified CD34 cells of donor origin in order to augment graft function in response to declining chimerism after initially performing an allogeneic hematopoietic stem cell transplant HSCT for children with primary immunodeficiency diseases This protocol will be utilized for patients with waning mixed donor chimerism that is inadequate for correction of clinical condition or disease for which stem cell transplant was performed or for augmentation of immune function An infusion of selected CD34 stem cells will be given without any preparative regimen As the children eligible for this protocol have reduced immune function and pre-existing donor chimerism we hypothesize that stem cells will be able to engraft and the infusion will augment graft function This therapy serves as an alternative to a second stem cell transplant that is known to be associated with significant morbidity and mortality CD34 stem cells will be collected from the donor used for initial stem cell transplant Cells will be T-cell depleted TCD by performing a CD34 selection using the CliniMACS device Miltenyi Biotec in order to prevent development of new or exacerbation of existing graft versus host disease GVHD as avoidance of GVHD in nonmalignant diseases is desirable There is sufficient data showing that mixed donor chimerism is adequate for reverting disease phenotype in certain primary immunodeficiencies Observations from Europe and CCHMC show that donor chimerism might be boosted by CD34 stem cell infusion alone without any specific preparative regimen This therapy is likely to be associated with low toxicity due to the absence of a preparative regimen and lack of exposure to fresh donor cells capable of initiating GVHD and offers potential significant benefit
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