Evidence map›Paper›PMID 36113170›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2023

Evaluation of neurotrophic factor secreting mesenchymal stem cells in progressive multiple sclerosis.

Jeffrey A Cohen, Fred D Lublin, Christoper Lock, Daniel Pelletier, Tanuja Chitnis, Munish Mehra, Yael Gothelf, Revital Aricha, Stacy Lindborg, Chaim Lebovits and 3 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.7field-weighted citation impact, top 3% 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.

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

21 citing papers in PubMed, 38 citations in OpenAlex.

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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 at 6 institutions in 1 country.

Jeffrey A CohenDepartment of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9245-9772
Fred D LublinDepartment of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Christoper LockDepartment of Neurology & Neurological Sciences, Stanford University School of Medicine, Palo Alto, CA, USA.
Daniel PelletierDepartment of Neurology, University of Southern California, Los Angeles, CA, USA.
Tanuja ChitnisDepartment of Neurology, Brigham and Women's Hospital, Boston, MA, USA.ORCID 0000-0002-9897-4422
Munish MehraDepartment of Statistics, Tigermed, Somerset, NJ, USA.
Yael GothelfDepartment of Research & Development, Brainstorm Cell Therapeutics, New York, NY, USA.
Revital ArichaDepartment of Research & Development, Brainstorm Cell Therapeutics, New York, NY, USA.
Stacy LindborgDepartment of Research & Development, Brainstorm Cell Therapeutics, New York, NY, USA.
Chaim LebovitsDepartment of Research & Development, Brainstorm Cell Therapeutics, New York, NY, USA.
Yossef LevyDepartment of Research & Development, Brainstorm Cell Therapeutics, New York, NY, USA.
Afsaneh Motamed KhorasaniDepartment of Research & Development, Brainstorm Cell Therapeutics, New York, NY, USA.
Ralph KernDepartment of Research & Development, Brainstorm Cell Therapeutics, New York, NY, USA.
Circuit Therapeutics (United States) · USBrigham and Women's Hospital · USCleveland Clinic · USIcahn School of Medicine at Mount Sinai · USStanford University · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutologous mesenchymal stem cell neurotrophic factor-secreting cells (NurOwn

objectiveThis open-label phase II study was conducted to evaluate safety/efficacy of three intrathecal cell treatments.

methodsEighteen participants with non-relapsing PMS were treated. The primary endpoint was safety. Secondary endpoints included: cerebrospinal fluid (CSF) biomarkers; timed 25-foot walk speed, nine-hole peg test (9-HPT), low-contrast letter acuity, symbol digit modalities test, and 12-item multiple sclerosis (MS) walking scale. Seventeen participants received all treatments.

resultsNo deaths/adverse events related to worsening of MS, clinical/magnetic resonance imaging (MRI) evidence of disease activation, and clinically significant changes in safety lab results were reported. Two participants developed symptoms of low back and leg pain, consistent with a diagnosis of arachnoiditis, occurring in one of three intrathecal treatments in both participants. Nineteen percent of treated participants achieved pre-specified ⩾ 25% improvements in timed 25-foot walk speed/nine-HPT at 28 weeks compared to baseline, along with consistent efficacy signals for pre-specified response criteria across other secondary efficacy outcomes. CSF neuroprotective factors increased, and inflammatory biomarkers decreased after treatment, consistent with the proposed mechanism of action.

conclusionBased on these encouraging preliminary findings, further confirmation in a randomized study is warranted.

Indexed as

Mesenchymal Stem CellsMultiple SclerosisMultiple Sclerosis, Chronic ProgressiveBiomarkersHumansNerve Growth FactorsBiomarkersNerve Growth Factorsbiomarkercell therapymesenchymal stem cell–neurotrophic factor cellsneuroprotectionProgressive multiple sclerosisstem cells

Identifiers

PMID36113170
PMCPMC9896300
OpenAlexW4296131366

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.