- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001451
Evaluation of Healthy Volunteer Marrow Donors Participating in the National Marrow Donor Program (NMDP)
June 30, 2017 updated by: National Institutes of Health Clinical Center (CC)
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.
Study Overview
Status
Completed
Conditions
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 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.
Study Type
Observational
Enrollment (Actual)
57
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1046/j.1537-2995.1993.33793325052.x.
- 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. doi: 10.1056/NEJM199303043280901.
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 14, 1995
Study Completion
February 1, 2011
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
November 3, 1999
First Posted (ESTIMATE)
November 4, 1999
Study Record Updates
Last Update Posted (ACTUAL)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 30, 2017
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 950123
- 95-CC-0123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet