Evidence map›Paper›PMID 38071749›Full record

Trial reportStem cells translational medicine2024

A Randomized, Placebo-Controlled, Phase II Trial of Intravenous Allogeneic Non-HLA Matched, Unrelated Donor, Cord Blood Infusion for Ischemic Stroke.

Daniel T Laskowitz, Jesse Troy, Emily Poehlein, Ellen R Bennett, Elizabeth J Shpall, John R Wingard, Brian Freed, Samir R Belagaje, Anna Khanna, William Jones and 3 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cells translational medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

13 authors.

Daniel T LaskowitzDepartment of Neurology, Duke University School of Medicine, Durham, NC, USA.
Jesse TroyDepartment of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
Emily PoehleinDepartment of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
Ellen R BennettDepartment of Neurology, Duke University School of Medicine, Durham, NC, USA.
Elizabeth J ShpallThe MD Anderson Cord Blood Bank, Houston, TX, USA.
John R WingardLifeSouth Cord Blood Bank, University of Florida, Gainesville, FL, USA.
Brian FreedClinImmune Labs, University of Colorado Cord Blood Bank, Aurora, CO, USA.
Samir R BelagajeDepartments of Neurology and Rehabilitation Medicine, Emory University School of Medicine, Atlanta, GA, USA.
Anna KhannaDepartment of Neurology, University of Florida, Gainesville, FL, USA.
William JonesDepartment of Neurology, University of Colorado, Aurora, CO, USA.
John J VolpiDepartment of Neurology, Houston Methodist, Houston, TX, USA.
Eric MarrotteDepartment of Neurology, Wake Forest University Baptist Medical Center, Winston-Salem, NC, USA.
Joanne KurtzbergMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.ORCID 0000-0002-3370-0703

Funding

Marcus Foundation
6 · The paper itself

Abstract

Stroke remains a leading cause of death and disability in the US, and time-limited reperfusion strategies remain the only approved treatment options. To address this unmet clinical need, we conducted a phase II randomized clinical trial to determine whether intravenous infusion of banked, non-HLA matched unrelated donor umbilical cord blood (UCB) improved functional outcome after stroke. Participants were randomized 2:1 to UCB or placebo within strata of National Institutes of Health Stroke Scale Score (NIHSS) and study center. Study product was infused 3-10 days following index stroke. The primary endpoint was change in modified Rankin Scale (mRS) from baseline to day 90. Key secondary outcomes included functional independence, NIHSS, the Barthel Index, and assessment of adverse events. The trial was terminated early due to slow accrual and logistical concerns associated with the COVID-19 pandemic, and a total of 73 of a planned 100 participants were included in primary analyses. The median (range) of the change in mRS was 1 point (-2, 3) in UCB and 1 point (-1,4) in Placebo (P = 0.72). A shift analysis comparing the mRS at day 90 utilizing proportional odds modeling showed a common odds ratio of 0.9 (95% CI: 0.4, 2.3) after adjustment for baseline NIHSS and randomization strata. The distribution of adverse events was similar between arms. Although this study did not suggest any safety concerns related to UCB in ischemic stroke, we did not show a clinical benefit in the reduced sample size evaluated.

Indexed as

Brain IschemiaHematopoietic Stem Cell TransplantationIschemic StrokeStrokeDouble-Blind MethodFetal BloodHumansPandemicsTreatment OutcomeUnrelated Donorscellular therapyclinical trialsstem cellsstrokeumbilical cord blood

Identifiers

PMID38071749
PMCPMC10872695

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.