Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005730
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-05-25
Brief Title:
National Marrow Donor Program NMDP
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
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:
To serve as a focal point for bone-marrow research
Detailed Description:
BACKGROUND
In 1986 the Department of the Navy initiated the National Bone Marrow Donor Registry Because the support of a National Bone Marrow Donor Registry was not very closely related to the Navys primary missions in 1989 the management of the contract for the program was transferred by the Congress from the Navy to the NHLBI
By 1989 bone marrow transplantation had become an effective and accepted treatment for an increasing number of diseases of the bone marrow and the immune system Until only a few years prior to 1989 most marrow donors were siblings carefully matched for HLA tissue antigens Since only a small proportion of candidates for a bone marrow transplant have matched brothers or sisters additional family members were tried as donors These included parents children slightly mismatched siblings and other relatives Even with the broadening of the bone marrow donor source no more than 30-40 percent of patients with diseases amenable to marrow transplant therapy had available donors Improved results with these selectively mismatched relatives and a distinct need to provide appropriate treatment for more patients led to trials with unrelated HLA-matched community volunteers as bone marrow donors By 1989 research had progressed to the point where transplants from such unrelated donors were nearly as successful as those from matched siblings when stratified by disease status and risk parameters In 1989 20 to 25 percent of patients for whom a formal donor search was initiated received a transplant This was expected to increase substantially
DESIGN NARRATIVE
The program was established by the Department of the Navy in 1986 and transferred to the NHLBI in 1989 The purpose was to develop and maintain a registry of individuals willing to donate bone marrow for patients in need of transplants to facilitate marrow transplants by serving as a coordinating and communications center for a network of donor collection and transplant centers in the United States and internationally and to facilitate research into the efficacy of unrelated donor marrow transplants In 1992 the program was enlarged to support a limited number of demonstration projects to develop implement and evaluate innovative models for minority marrow donor recruitment In 1995 the NMDP was transferred to the Health Resources and Services Administration HRSA although NHLBI provided funds in this year
In 1986 the Department of the Navy initiated the National Bone Marrow Donor Registry Because the support of a National Bone Marrow Donor Registry was not very closely related to the Navys primary missions in 1989 the management of the contract for the program was transferred by the Congress from the Navy to the NHLBI
By 1989 bone marrow transplantation had become an effective and accepted treatment for an increasing number of diseases of the bone marrow and the immune system Until only a few years prior to 1989 most marrow donors were siblings carefully matched for HLA tissue antigens Since only a small proportion of candidates for a bone marrow transplant have matched brothers or sisters additional family members were tried as donors These included parents children slightly mismatched siblings and other relatives Even with the broadening of the bone marrow donor source no more than 30-40 percent of patients with diseases amenable to marrow transplant therapy had available donors Improved results with these selectively mismatched relatives and a distinct need to provide appropriate treatment for more patients led to trials with unrelated HLA-matched community volunteers as bone marrow donors By 1989 research had progressed to the point where transplants from such unrelated donors were nearly as successful as those from matched siblings when stratified by disease status and risk parameters In 1989 20 to 25 percent of patients for whom a formal donor search was initiated received a transplant This was expected to increase substantially
DESIGN NARRATIVE
The program was established by the Department of the Navy in 1986 and transferred to the NHLBI in 1989 The purpose was to develop and maintain a registry of individuals willing to donate bone marrow for patients in need of transplants to facilitate marrow transplants by serving as a coordinating and communications center for a network of donor collection and transplant centers in the United States and internationally and to facilitate research into the efficacy of unrelated donor marrow transplants In 1992 the program was enlarged to support a limited number of demonstration projects to develop implement and evaluate innovative models for minority marrow donor recruitment In 1995 the NMDP was transferred to the Health Resources and Services Administration HRSA although NHLBI provided funds in this year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: