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Unlicensed Umbilical Cord Blood Units Provide a Safe and Effective Graft Source for a Diverse Population: A Study of 2456 Umbilical Cord Blood Recipients.

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Date
2020-04
Authors
Ballen, Karen
Logan, Brent R
Chitphakdithai, Pintip
Kuxhausen, Michelle
Spellman, Stephen R
Adams, Alexia
Drexler, Rebecca J
Duffy, Merry
Kemp, Ann
King, Roberta
Babic, Aleksandar
Delaney, Colleen
Karanes, Chatchada
Kurtzberg, Joanne
Petz, Lawrence
Scaradavou, Andromachi
Shpall, Elizabeth J
Smith, Clayton
Confer, Dennis L
Miller, John P
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Abstract
Umbilical cord blood (UCB) transplantation (UCBT) is a curative procedure for patients with hematologic malignancies and genetic disorders and expands access to transplantation for non-Caucasian patients unable to find a fully matched unrelated donor. In 2011, the US Food and Drug Administration required that unrelated UCBT be performed using either licensed UCB or unlicensed UCB under the Investigational New Drug (IND) program. The National Marrow Donor Program manages an IND under which 2456 patients (1499 adults and 957 children, 564 with malignant diseases and 393 with nonmalignant diseases) underwent single or double UCBT between October 2011 and December 2016. The median patient age was 31 years (range, <1 to 81 years), and 50% of children and 36% of adults were non-Caucasian. The median time to neutrophil engraftment (ie, absolute neutrophil count ≥500/mm<sup>3</sup>) was 22 days for adults, 20 days for pediatric patients with malignant diseases, and 19 days for pediatric patients with nonmalignant diseases, with corresponding rates of engraftment at 42 days of 89%, 88%, and 90%. In these 3 groups of patients, the incidence of acute graft-versus-host disease (GVHD) grade II-IV was 35%, 32%, and 24%; the incidence of chronic GVHD was 24%, 26%, and 24%; and 1-year overall survival (OS) was 57%, 71%, and 79%, respectively. In multivariate analysis, younger age, lower Hematopoietic Cell Transplantation-Specific Comorbidity Index, early-stage chemotherapy-sensitive disease, and higher performance score were predictive of improved OS for adults. In a subset analysis of children with malignancies undergoing single UCBT, the use of either licensed UCB (n = 48) or unlicensed UCB (n = 382) was associated with similar engraftment and survival. The use of unlicensed UCB units is safe and effective and provides an important graft source for a diverse population.
Type
Journal article
Subject
Fetal Blood
Humans
Hematologic Neoplasms
Graft vs Host Disease
Cord Blood Stem Cell Transplantation
Hematopoietic Stem Cell Transplantation
Adolescent
Adult
Aged
Aged, 80 and over
Middle Aged
Child
Child, Preschool
Infant
Young Adult
Permalink
https://hdl.handle.net/10161/24565
Published Version (Please cite this version)
10.1016/j.bbmt.2019.11.016
Publication Info
Ballen, Karen; Logan, Brent R; Chitphakdithai, Pintip; Kuxhausen, Michelle; Spellman, Stephen R; Adams, Alexia; ... Miller, John P (2020). Unlicensed Umbilical Cord Blood Units Provide a Safe and Effective Graft Source for a Diverse Population: A Study of 2456 Umbilical Cord Blood Recipients. Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 26(4). pp. 745-757. 10.1016/j.bbmt.2019.11.016. Retrieved from https://hdl.handle.net/10161/24565.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Kurtzberg

Joanne Kurtzberg

Jerome S. Harris Distinguished Professor of Pediatrics
Dr. Kurtzberg conducts both clinical and laboratory-based translational research efforts, all involving various aspects of normal and malignant hematopoiesis. In the laboratory, her early work focused on studies determining the mechanisms that regulate the choice between the various pathways of differentiation available to the pluripotent hematopoietic stem cell. Her laboratory established a CD7+ cell line, DU.528, capable of multilineage differentiation as well as self-renewal, and subse
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