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Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study.

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Date
2018-07
Authors
Laskowitz, Daniel T
Bennett, Ellen R
Durham, Rebecca J
Volpi, John J
Wiese, Jonathan R
Frankel, Michael
Shpall, Elizabeth
Wilson, Jeffry M
Troy, Jesse
Kurtzberg, Joanne
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Abstract
Stroke is a major cause of death and long-term disability, affecting one in six people worldwide. The only currently available approved pharmacological treatment for ischemic stroke is tissue plasminogen activator; however, relatively few patients are eligible for this therapy. We hypothesized that intravenous (IV) infusion of banked unrelated allogeneic umbilical cord blood (UCB) would improve functional outcomes in patients with ischemic stroke. To investigate this, we conducted a phase I open-label trial to assess the safety and feasibility of a single IV infusion of non-human leukocyte antigen (HLA) matched, ABO matched, unrelated allogeneic UCB into adult stroke patients. Ten participants with acute middle cerebral artery ischemic stroke were enrolled. UCB units were matched for blood group antigens and race but not HLA, and infused 3-9 days post-stroke. The adverse event (AE) profile over a 12 month postinfusion period indicated that the treatment was well-tolerated in these stroke patients, with no serious AEs directly related to the study product. Study participants were also assessed using neurological and functional evaluations, including the modified Rankin Score (mRS) and National Institute of Health Stroke Scale (NIHSS). At 3 months post-treatment, all participants had improved by at least one grade in mRS (mean 2.8 ± 0.9) and by at least 4 points in NIHSS (mean 5.9 ± 1.4), relative to baseline. Together, these data suggest that a single i.v. dose of allogeneic non-HLA matched human UCB cells is safe in adults with ischemic stroke, and support the conduct of a randomized, placebo-controlled phase 2 study. Stem Cells Translational Medicine 2018;7:521-529.
Type
Journal article
Subject
Brain
Fetal Blood
Humans
Graft vs Host Disease
HLA Antigens
Magnetic Resonance Imaging
Treatment Outcome
Transplantation, Homologous
Aged
Middle Aged
Female
Male
Stroke
Permalink
https://hdl.handle.net/10161/22425
Published Version (Please cite this version)
10.1002/sctm.18-0008
Publication Info
Laskowitz, Daniel T; Bennett, Ellen R; Durham, Rebecca J; Volpi, John J; Wiese, Jonathan R; Frankel, Michael; ... Kurtzberg, Joanne (2018). Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study. Stem cells translational medicine, 7(7). pp. 521-529. 10.1002/sctm.18-0008. Retrieved from https://hdl.handle.net/10161/22425.
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

Bennett

Ellen Ruth Bennett

Adjunct Assistant Professor in the Department of Neurology
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
Laskowitz

Daniel Todd Laskowitz

Professor of Neurology
Our laboratory uses molecular biology, cell culture, and animal modeling techniques to examine the CNS response to acute injury. In particular, our laboratory examines the role of microglial activation and the endogenous CNS inflammatory response in exacerbating secondary injury following acute brain insult. Much of the in vitro work in this laboratory is dedicated to elucidating cellular responses to injury with the ultimate goal of exploring new therapeutic interventions in the clinical settin
Troy

Jesse David Troy

Assistant Professor of Biostatistics & Bioinformatics
I am a biostatistician supporting research in cell therapies and regenerative medicine at the Duke Marcus Center for Cellular Cures, and research studies in cancer therapeutics and palliative care at the Duke Cancer Institute. I also teach biostatistics in the Master of Biostatistics program and the <a href="
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