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

Publication ,  Journal Article
Laskowitz, DT; Bennett, ER; Durham, RJ; Volpi, JJ; Wiese, JR; Frankel, M; Shpall, E; Wilson, JM; Troy, J; Kurtzberg, J
Published in: Stem Cells Transl Med
July 2018

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.

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Published In

Stem Cells Transl Med

DOI

ISSN

2157-6564

Publication Date

July 2018

Volume

7

Issue

7

Start / End Page

521 / 529

Location

England

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Homologous
  • Stroke
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
  • Humans
  • HLA Antigens
  • Graft vs Host Disease
  • Fetal Blood
 

Citation

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Chicago
ICMJE
MLA
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Laskowitz, D. T., Bennett, E. R., Durham, R. J., Volpi, J. J., Wiese, J. R., Frankel, M., … Kurtzberg, J. (2018). Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study. Stem Cells Transl Med, 7(7), 521–529. https://doi.org/10.1002/sctm.18-0008
Laskowitz, Daniel T., Ellen R. Bennett, Rebecca J. Durham, John J. Volpi, Jonathan R. Wiese, Michael Frankel, Elizabeth Shpall, Jeffry M. Wilson, Jesse Troy, and Joanne Kurtzberg. “Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study.Stem Cells Transl Med 7, no. 7 (July 2018): 521–29. https://doi.org/10.1002/sctm.18-0008.
Laskowitz DT, Bennett ER, Durham RJ, Volpi JJ, Wiese JR, Frankel M, et al. Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study. Stem Cells Transl Med. 2018 Jul;7(7):521–9.
Laskowitz, Daniel T., et al. “Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study.Stem Cells Transl Med, vol. 7, no. 7, July 2018, pp. 521–29. Pubmed, doi:10.1002/sctm.18-0008.
Laskowitz DT, Bennett ER, Durham RJ, Volpi JJ, Wiese JR, Frankel M, Shpall E, Wilson JM, Troy J, Kurtzberg J. Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study. Stem Cells Transl Med. 2018 Jul;7(7):521–529.

Published In

Stem Cells Transl Med

DOI

ISSN

2157-6564

Publication Date

July 2018

Volume

7

Issue

7

Start / End Page

521 / 529

Location

England

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Homologous
  • Stroke
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
  • Humans
  • HLA Antigens
  • Graft vs Host Disease
  • Fetal Blood