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Evaluation of Healthy Volunteer Marrow Donors Participating in the National Marrow Donor Program (NMDP) - Article


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Clinical Trial: Evaluation of Healthy Volunteer Marrow Donors Participating in the National Marrow Donor Program (NMDP)

This study is currently recruiting patients.

Sponsored by: Warren G Magnuson Clinical Center (CC)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

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 blood drawn 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.

Condition
Healthy

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Screening

Further Study Details: 

Expected Total Enrollment:  100

Study start: March 14, 1995

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 one of the largest hospital-based Donor Centers in the nation, with 55,200 active donors on its registry. 355 NIH unrelated donors to date have undergone 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. The evaluation is usually performed by a "third party" non-NIH physician, 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" physician's 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.

Eligibility

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA:
Age 18-60.
Must meet same criteria as that of a volunteer blood donor.
EXCLUSION CRITERIA:
History of hepatitis.
History of intravenous use of illicit drugs.
History of activities that increase the risk of exposure to HIV or hepatitis viruses.
Inability to tolerate general anesthesia.
Obesity.
Hypertension.
Asthma.
Diabetic patients will be excluded.
Pregnant patients will be excluded.

Location and Contact Information


Maryland
      Warren G. Magnuson Clinical Center (CC), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Publications

Stroncek D, Bartsch G, Perkins HA, Randall BL, Hansen JA, McCullough J. The National Marrow Donor Program. Transfusion. 1993 Jul;33(7):567-77.

Kernan NA, Bartsch G, Ash RC, Beatty PG, Champlin R, Filipovich A, Gajewski J, Hansen JA, Henslee-Downey J, McCullough J, et al. Analysis of 462 transplantations from unrelated donors facilitated by the National Marrow Donor Program. N Engl J Med. 1993 Mar 4;328(9):593-602.

Stroncek DF, Shankar RA, Herr GP. Quinine-dependent antibodies to neutrophils react with a 60-Kd glycoprotein on which neutrophil-specific antigen NB1 is located and an 85-Kd glycosyl-phosphatidylinositol-linked N-glycosylated plasma membrane glycoprotein. Blood. 1993 May 15;81(10):2758-66.

Study ID Numbers:  950123; 95-CC-0123
Record last reviewed:  March 18, 2005
Last Updated:  March 29, 2005
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001451
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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