Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212407
Status:
TERMINATED
Last Update Posted:
2018-11-02
First Post:
2005-09-13
Brief Title:
New York Blood Center National Cord Blood Program
Sponsor:
New York Blood Center
Organization:
New York Blood Center
Study Overview
Official Title:
New York Blood Center National Cord Blood Program
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study NCT01656603 supersedes this study FDA IND 6637
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor The outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment transplant related mortality overall survival graft vs host disease and for patients with leukemia lymphoma or myelodysplasia relapse
Detailed Description:
Umbilical cord blood donated to the New York Blood Centers National Cord Blood Program is collect tested processed cryoprotected and frozen in liquid nitrogen for possible future transplantation to anyone who needs it The Program has operated under a FDA IND exemption since 1996 and is licensed as a tissue bank by the New York State Department of Health
Candidates for transplant are patients who disease requires bone marrow transplantation but who do not have a suitable related bone marrow donor Most patients are those with high risk of refractory leukemia lymphoma myelodysplasia severe aplastic anemia and certain genetic hematologic immunologic and metabolic diseases
Patients are treated at bone marrow transplant centers in the United States and in other countries with active marrow transplant programs Because the NYBC Program operates under IND patients must sign an informed consent for cord blood transplantation
Transplant centers report on the transplant procedure including immediate complications and on transplant outcome at 3 6 and 12 months post-transplant and annually thereafter Data report to the New York Blood Center includes information about the patients disease and pre-transplant conditioning regimen and post-transplant endpoints primarily myeloid and platelet engraftment transplant related mortality overall survival acute and chronic graft vs host disease relapse and other post-transplant complications such as infectious disease The outcome data is used to assess safety and efficacy and will be used to apply for a license from the FDA
Candidates for transplant are patients who disease requires bone marrow transplantation but who do not have a suitable related bone marrow donor Most patients are those with high risk of refractory leukemia lymphoma myelodysplasia severe aplastic anemia and certain genetic hematologic immunologic and metabolic diseases
Patients are treated at bone marrow transplant centers in the United States and in other countries with active marrow transplant programs Because the NYBC Program operates under IND patients must sign an informed consent for cord blood transplantation
Transplant centers report on the transplant procedure including immediate complications and on transplant outcome at 3 6 and 12 months post-transplant and annually thereafter Data report to the New York Blood Center includes information about the patients disease and pre-transplant conditioning regimen and post-transplant endpoints primarily myeloid and platelet engraftment transplant related mortality overall survival acute and chronic graft vs host disease relapse and other post-transplant complications such as infectious disease The outcome data is used to assess safety and efficacy and will be used to apply for a license from the FDA
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