Evidence map›Paper›PMID 29752869›Full record

ArticleStem cells translational medicine2018

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

Daniel T Laskowitz, Ellen R Bennett, Rebecca J Durham, John J Volpi, Jonathan R Wiese, Michael Frankel, Elizabeth Shpall, Jeffry M Wilson, Jesse Troy, Joanne Kurtzberg

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Stem cells translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02397018 (Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke), which is not on this map. Cited by 66 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 4 pooled it
8.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02397018 phase1completednot on this map

Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke

TypeinterventionalSponsorJoanne Kurtzberg, MDRan2015 to 2017Enrolled10ConditionsStrokeArmsallogeneic umbilical cord blood
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 4 syntheses or guidelines pooled it, 120 citations in OpenAlex.

  1. Pooled it
  2. A review and meta-analysis of stem cell therapies in stroke patients: effectiveness and safety evaluation.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Pooled it
  3. Pooled it
  4. Stem cell transplantation for ischemic stroke.The Cochrane database of systematic reviews · 2019
    Pooled it
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  19. Brain repair mechanisms after cell therapy for stroke.Brain : a journal of neurology · 2024
    Review
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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Daniel T LaskowitzDepartment of Neurology, Duke University, Durham, North Carolina, USA.
Ellen R BennettDepartment of Neurology, Duke University, Durham, North Carolina, USA.ORCID 0000-0002-9454-824X
Rebecca J DurhamRobertson Clinical and Translational Cell Therapy Program, Duke Translational Research Institute/Duke University, Durham, North Carolina, USA.
John J VolpiEddy Scurlock Stroke Center, Houston Methodist Neurological Institute, Houston, Texas, USA.
Jonathan R WieseEddy Scurlock Stroke Center, Houston Methodist Neurological Institute, Houston, Texas, USA.
Michael FrankelDepartment of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
Elizabeth ShpallMD Anderson Cancer Center, The University of Texas, Houston, Texas, USA.
Jeffry M WilsonMD Anderson Cancer Center, The University of Texas, Houston, Texas, USA.
Jesse TroyRobertson Clinical and Translational Cell Therapy Program, Duke Translational Research Institute/Duke University, Durham, North Carolina, USA.
Joanne KurtzbergRobertson Clinical and Translational Cell Therapy Program, Duke Translational Research Institute/Duke University, Durham, North Carolina, USA.
Duke University · USDuke University Hospital · USHouston Methodist · USThe University of Texas MD Anderson Cancer Center · USEmory University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AgedBrainFemaleFetal BloodGraft vs Host DiseaseHLA AntigensHumansMagnetic Resonance ImagingMaleMiddle AgedStrokeTransplantation, HomologousTreatment OutcomeHLA AntigensCellular therapyClinical trialsCord bloodHuman cord bloodStem cellsUmbilical cordUmbilical cord blood

Identifiers

PMID29752869
PMCPMC6052613
OpenAlexW2802092949

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.