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Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study.
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 articleSubject
BrainFetal Blood
Humans
Graft vs Host Disease
HLA Antigens
Magnetic Resonance Imaging
Treatment Outcome
Transplantation, Homologous
Aged
Middle Aged
Female
Male
Stroke
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https://hdl.handle.net/10161/22425Published Version (Please cite this version)
10.1002/sctm.18-0008Publication 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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Show full item recordScholars@Duke
Ellen Ruth Bennett
Adjunct Assistant Professor in the Department of Neurology
Joanne Kurtzberg
Jerome S. Harris Distinguished Professor of Pediatrics
Dr. Kurtzberg is an internationally renowned expert in pediatric hematology/oncology,
pediatric blood and marrow transplantation, umbilical cord blood banking and transplantation,
and novel applications of cord blood and birthing tissues in the emerging fields of
cellular therapies and regenerative medicine. Dr. Kurtzberg serves as the Director
of the Marcus Center for Cellular Cures (MC3), Director of the Pediatric Transplant
and Cellular Therapy Program, Director of the Carolina
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
Jesse David Troy
Associate Professor of Biostatistics & Bioinformatics
I am a biostatistician supporting research in cancer therapeutics and palliative care
at the Duke Cancer Institute. Prior to this I supported research studies in cell therapies
and regenerative medicine at the Duke Marcus Center for Cellular Cures. I also teach
biostatistics in the Master of Biostatisti
Alphabetical list of authors with Scholars@Duke profiles.

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