Evaluation of Healthy Volunteer Marrow Donors Participating in the National Marrow Donor Program (NMDP)
Data Collection
Summary
Study start date: March 14, 1995
Actual date on which the first participant was enrolled.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 55,900 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" 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.57 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.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. Confirmed positive test for HIV Inability to tolerate general anesthesia. Obesity. Hypertension. Asthma. Diabetic patients will be excluded. Pregnant patients will be excluded.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps