Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001451
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Evaluation of Healthy Volunteer Marrow Donors Participating in the National Marrow Donor Program NMDP
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Healthy Volunteer Marrow Donors Participating in the National Marrow Donor Program NMDP
Status:
COMPLETED
Status Verified Date:
2011-02-01
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:
Individuals interested in becoming prospective bone marrow donors and joining the Registry of the National Marrow Donor Program NMDP should do so by calling 301-496-0572 the phone number of the NIH Marrow Donor Center An appointment will be made to have a health history taken and to have a buccal swab collected for tissue HLA typing The current protocol only involves donors already registered with the NMDP who have been identified as perfect matches for an unrelated patient requiring a bone marrow transplant and who require expedited medical evaluation prior to marrow collection
Detailed Description:
The National Marrow Donor Program NMDP was established in 1987 in order to 1 create a registry of volunteer prospectively tissue-typed unrelated bone marrow donors 2 facilitate the performance of matched unrelated donor marrow transplants through a coordinated circuit of Donor Centers Collection Centers and Transplant Centers throughout the United States and 3 evaluate the outcome of such transplants and identify future areas of research in the field of unrelated donor marrow transplants The NIH Marrow Donor Center a participant in the NMDP is currently the second largest hospital-based Donor Center in the nation with approximately 55900 active donors on its registry 402 NIH unrelated donors to date have undergone 429 marrow or blood stem cell harvest for an NMDP recipient and the current rate of such harvests is three per month Once an HLA-matched donor in the NIH Donor Center registry is identified through the NMDP computer network the donor must undergo a medical evaluation to determine suitability for marrow harvest This evaluation consists of a medical history a physical examination routine blood work EKG chest x-ray and urinalysis and generally takes 4 to 6 weeks A third party non-NIH physician usually performs the evaluation with the costs reimbursed by the NMDP Occasionally an expedited evaluation of an unrelated donor must be performed due to the urgency of the need for a transplant in the recipient and there is insufficient time to accomplish this work-up using the routine third-party physicians office mechanism This protocol shall provide a means by which prospective NIH unrelated marrow donors participating in the NMDP program can undergo an expedited medical evaluation to determine suitability for marrow donation It is expected that not more than 5 to 10 donors per year shall require such expedited evaluation
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 |
|---|---|---|---|
| 95-CC-0123 | None | None | None |