Evidence map›Paper›PMID 29449193›Full record

ArticleEBioMedicine2018

Phase I Trial of Intrathecal Mesenchymal Stem Cell-derived Neural Progenitors in Progressive Multiple Sclerosis.

Violaine K Harris, James Stark, Tamara Vyshkina, Leslie Blackshear, Gloria Joo, Valentina Stefanova, Gabriel Sara, Saud A Sadiq

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in EBioMedicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 93 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 6 pooled it
12.2field-weighted citation impact, top 1% 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.

NCT01933802 phase1completednot on this map

Phase 1 Safety Study of Autologous Bone Marrow-derived Mesenchymal Stem Cell-derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo, Administered Intrathecally in Patients With Multiple Sclerosis

TypeinterventionalSponsorTisch Multiple Sclerosis Research Center of New YorkRan2014 to 2017Enrolled20ConditionsMultiple SclerosisArmsintrathecal administration of autologous MSC-NP
NCT03355365 phase2completednot on this map

Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally

TypeinterventionalSponsorTisch Multiple Sclerosis Research Center of New YorkRan2018 to 2023Enrolled54ConditionsMultiple SclerosisArmsIntrathecal MSC-NP injection, Intrathecal saline injection
NCT03822858 availablenot on this map

Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally

Typeexpanded_accessSponsorTisch Multiple Sclerosis Research Center of New YorkConditionsMultiple SclerosisArmsIntrathecal MSC-NP injection
3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 6 syntheses or guidelines pooled it, 172 citations in OpenAlex.

  1. The use of stem cells in treating xerostomia: a systematic review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
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  10. Stem Cell-Based Therapies for Central Nervous System Demyelinating Diseases: Clinical Evidence, Therapeutic Niches, and Translational Boundaries.Medical science monitor : international medical journal of experimental and clinical research · 2026
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33 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Violaine K HarrisTisch Multiple Sclerosis Research Center of New York, New York, NY, USA.
James StarkTisch Multiple Sclerosis Research Center of New York, New York, NY, USA.
Tamara VyshkinaTisch Multiple Sclerosis Research Center of New York, New York, NY, USA.
Leslie BlackshearTisch Multiple Sclerosis Research Center of New York, New York, NY, USA.
Gloria JooTisch Multiple Sclerosis Research Center of New York, New York, NY, USA.
Valentina StefanovaTisch Multiple Sclerosis Research Center of New York, New York, NY, USA.
Gabriel SaraDepartment of Hematology and Medical Oncology, Mount Sinai Hospital, New York, NY, USA.
Saud A SadiqTisch Multiple Sclerosis Research Center of New York, New York, NY, USA. Electronic address: ssadiq@tischms.org.
Tisch Hospital · USMount Sinai Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultiple sclerosis (MS) is an immune-mediated demyelinating disease of the central nervous system and is one of the leading causes of disability in young adults. Cell therapy is emerging as a therapeutic strategy to promote repair and regeneration in patients with disability associated with progressive MS.

methodsWe conducted a phase I open-label clinical trial investigating the safety and tolerability of autologous bone marrow mesenchymal stem cell-derived neural progenitor (MSC-NP) treatment in 20 patients with progressive MS. MSC-NPs were administered intrathecally (IT) in three separate doses of up to 1 × 10

findingsIT MSC-NP treatment was safe and well tolerated. The 20 enrolled subjects completed all 60 planned treatments without serious adverse effects. Minor adverse events included transient fever and mild headaches usually resolving in <24 h. Post-treatment disability score analysis demonstrated improved median EDSS suggesting possible efficacy. Positive trends were more frequently observed in the subset of SPMS patients and in ambulatory subjects (EDSS ≤ 6.5). In addition, 70% and 50% of the subjects demonstrated improved muscle strength and bladder function, respectively, following IT MSC-NP treatment.

interpretationThe possible reversal of disability that was observed in a subset of patients warrants a larger phase II placebo-controlled study to establish efficacy of IT MSC-NP treatment in patients with MS. FUNDING SOURCE: The Damial Foundation.

Indexed as

Cell- and Tissue-Based TherapyStem Cell TransplantationAdultAgedBiomarkersCell DifferentiationFemaleHumansInjections, SpinalMagnetic Resonance ImagingMaleMesenchymal Stem CellsMiddle AgedMultiple SclerosisNeural Stem CellsSymptom AssessmentBiomarkersClinical trialIntrathecalMesenchymal stem cellsMultiple sclerosis

Identifiers

PMID29449193
PMCPMC5925446
OpenAlexW2790928579

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.