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This multi-center study is an access and distribution protocol that lets doctors provide cryopreserved (frozen) cord blood units (CBUs) for patients who need them for treatment of disease, providing that the CBUs meet standards of the National Marrow Donor Program. Since 2011, the Food and Drug Administration (FDA) has considered CBUs a biological drug that must meet certain FDA standards to be used. Most CBUs available in the United States were collected before the FDA established these standards; however, the FDA allows use of these “unlicensed” CBUs if the transplant is being done as part of a study.
Subject to certain exclusion criteria, this study is enrolling participants of any age who need a CBU transplant to treat a disorder affecting the hematopoietic system.
Males and Females: All ages
CBUs will be infused through a vein in accordance with standard protocols for the patient’s condition and treatment. Medical information about each participant’s disease, transplant and outcome will be sent to the Center for International Blood and Marrow Transplant Research (CIBMT) by the participant’s doctor. Participation in the study will end a year after the patient’s cord blood transplant.
Visits: None beyond normal clinical care for the condition
Duration: 1 year post transplant
Study Description at the National Institutes of Health
Be The Match: National Marrow Donor Program
Blood and Marrow Transplantation and Cellular Therapies Research
Paul Szabolcs, MD
For more information about the study or enrollment, please contact:
Shawna McIntyre, Clinical Research Supervisor
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
In addition to the main hospital, Children's has many convenient locations in other neighborhoods throughout the greater Pittsburgh region.
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