Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186810
Status:
COMPLETED
Last Update Posted:
2009-05-29
First Post:
2005-09-09
Brief Title:
Stem Cell Transplantation With Identical Donors for Patients With Sickle Cell Disease
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Allogeneic Stem Cell Transplantation From HLAMLC Genotype Identical Donors for Patients With High Risk Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2009-05
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 studied the effect of administration of a myeloablative pretransplant preparative regimen followed by an infusion of donor stem cells in children with severe sickle cell disease The donor graft consisted of bone marrow or cord blood derived from a genetically matched sibling
The primary aim of the study was to evaluate how well the donated cells migrated to the bone marrow and begin producing healthy red blood cells white blood cells and platelets engrafted how well the recipients immune system recovered and assess any regimen related toxicities including a potentially life-threatening transplant related complication called graft-versus-host-disease or GVHD
The primary aim of the study was to evaluate how well the donated cells migrated to the bone marrow and begin producing healthy red blood cells white blood cells and platelets engrafted how well the recipients immune system recovered and assess any regimen related toxicities including a potentially life-threatening transplant related complication called graft-versus-host-disease or GVHD
Detailed Description:
The secondary objectives of this protocol evaluated the effect of this transplant procedure on the subsequent clinical course of patients with severe SCD Specifically to determine whether pre-transplant organ dysfunction brain heart lung kidney liver spleen etc resultant from sickle hemoglobinopathy can be reversed following this particular transplant procedure
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