Evidence map›Paper›PMID 27256670›Full record

Trial reportStroke2016

Clinical Outcomes of Transplanted Modified Bone Marrow-Derived Mesenchymal Stem Cells in Stroke: A Phase 1/2a Study.

Gary K Steinberg, Douglas Kondziolka, Lawrence R Wechsler, L Dade Lunsford, Maria L Coburn, Julia B Billigen, Anthony S Kim, Jeremiah N Johnson, Damien Bates, Bill King and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stroke, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01287936 (A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells), which is not on this map. Cited by 247 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
247citing papers in PubMed, 10 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.

NCT01287936 phase1 / phase2completednot on this map

A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke

TypeinterventionalSponsorSanBio, Inc.Ran2011 to 2015Enrolled18ConditionsChronic Ischemic StrokeArmsSB623
3 · Its place in the literature

Who cites it

247 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  4. Safety and efficacy of bone marrow mononuclear cell therapy for ischemic stroke recovery: a systematic review and meta-analysis of randomized controlled trials.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Pooled it
  5. 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
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  9. Stem cell transplantation for ischemic stroke.The Cochrane database of systematic reviews · 2019
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187 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Gary K SteinbergFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.). cerebral@stanford.edu.
Douglas KondziolkaFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Lawrence R WechslerFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
L Dade LunsfordFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Maria L CoburnFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Julia B BilligenFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Anthony S KimFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Jeremiah N JohnsonFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Damien BatesFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Bill KingFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Casey CaseFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Michael McGroganFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Ernest W YankeeFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).
Neil E SchwartzFrom the Department of Neurosurgery (G.K.S., M.L.C., J.N.J.) and Department of Neurology and Neurological Sciences (G.K.S., N.E.S.), Stanford University School of Medicine and Stanford Health Care, CA; Department of Neurosurgery, New York University and NYU Langone Medical Center, NY (D.K.); Department of Neurosurgery (L.D.L.) and Department of Neurology (L.R.W., J.B.B.), University of Pittsburgh Medical School and University of Pittsburgh Medical Center, PA; Department of Neurology, University of California, San Francisco (A.S.K.); SanBio, Inc, Mountain View, CA (D.B., C.C., M.M., E.W.Y.); and Western Statistical Consulting, LLC, Phoenix, AZ (B.K.).

Funding

Paracrine and synaptic mechanisms underlying recovery using human stem cell theraR01NS058784 · NINDS · STANFORD UNIVERSITY · PI STEINBERG, GARY K · 2008 to 2023
$6.6M
NINDS NIH HHS R01 NS058784
6 · The paper itself

Abstract

background and purposePreclinical data suggest that cell-based therapies have the potential to improve stroke outcomes.

methodsEighteen patients with stable, chronic stroke were enrolled in a 2-year, open-label, single-arm study to evaluate the safety and clinical outcomes of surgical transplantation of modified bone marrow-derived mesenchymal stem cells (SB623).

resultsAll patients in the safety population (N=18) experienced at least 1 treatment-emergent adverse event. Six patients experienced 6 serious treatment-emergent adverse events; 2 were probably or definitely related to surgical procedure; none were related to cell treatment. All serious treatment-emergent adverse events resolved without sequelae. There were no dose-limiting toxicities or deaths. Sixteen patients completed 12 months of follow-up at the time of this analysis. Significant improvement from baseline (mean) was reported for: (1) European Stroke Scale: mean increase 6.88 (95% confidence interval, 3.5-10.3; P<0.001), (2) National Institutes of Health Stroke Scale: mean decrease 2.00 (95% confidence interval, -2.7 to -1.3; P<0.001), (3) Fugl-Meyer total score: mean increase 19.20 (95% confidence interval, 11.4-27.0; P<0.001), and (4) Fugl-Meyer motor function total score: mean increase 11.40 (95% confidence interval, 4.6-18.2; P<0.001). No changes were observed in modified Rankin Scale. The area of magnetic resonance T2 fluid-attenuated inversion recovery signal change in the ipsilateral cortex 1 week after implantation significantly correlated with clinical improvement at 12 months (P<0.001 for European Stroke Scale).

conclusionsIn this interim report, SB623 cells were safe and associated with improvement in clinical outcome end points at 12 months. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01287936.

Indexed as

AdultAgedBone Marrow TransplantationFemaleHumansMaleMesenchymal Stem Cell TransplantationMiddle AgedStrokeTreatment Outcomeallogeneic transplantationmesenchymal stromal cellsNotch 1phase 1 clinical trialstem cellsstereotactic techniquesstroke

Identifiers

PMID27256670
PMCPMC5828512

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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.