Evidence map›Paper›PMID 29768414›Full record

Trial reportPloS one2018

Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study.

Oscar Fernández, Guillermo Izquierdo, Victoria Fernández, Laura Leyva, Virginia Reyes, Miguel Guerrero, Antonio León, Carlos Arnaiz, Guillermo Navarro, Maria Dolores Páramo and 16 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 6 pooled it
10.8field-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.

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

84 citing papers in PubMed, 6 syntheses or guidelines pooled it, 154 citations in OpenAlex.

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24 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

26 authors at 5 institutions in 2 countries.

Oscar FernándezUnidad de Gestión Clínica de Neurociencias Clínicas, Servicio de Neurología y Servicio de Neurofisiología, Hospital Regional Universitario, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Malaga, Malaga, Spain.ORCID 0000-0003-3696-789X
Guillermo IzquierdoServicio de Neurología, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
Victoria FernándezUnidad de Gestión Clínica de Neurociencias Clínicas, Servicio de Neurología y Servicio de Neurofisiología, Hospital Regional Universitario, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Malaga, Malaga, Spain.
Laura LeyvaUnidad de Gestión Clínica de Neurociencias Clínicas, Servicio de Neurología y Servicio de Neurofisiología, Hospital Regional Universitario, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Malaga, Malaga, Spain.
Virginia ReyesUnidad de Gestión Clínica de Neurociencias Clínicas, Servicio de Neurología y Servicio de Neurofisiología, Hospital Regional Universitario, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Malaga, Malaga, Spain.
Miguel GuerreroUnidad de Gestión Clínica de Neurociencias Clínicas, Servicio de Neurología y Servicio de Neurofisiología, Hospital Regional Universitario, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Malaga, Malaga, Spain.
Antonio LeónUnidad de Gestión Clínica de Neurociencias Clínicas, Servicio de Neurología y Servicio de Neurofisiología, Hospital Regional Universitario, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Malaga, Malaga, Spain.
Carlos ArnaizUnidad de Gestión Clínica de Neurociencias Clínicas, Servicio de Neurología y Servicio de Neurofisiología, Hospital Regional Universitario, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Malaga, Malaga, Spain.
Guillermo NavarroServicio de Neurología, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
Maria Dolores PáramoServicio de Neurología, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
Antonio De la CuestaServicio de Neurología, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
Bernat SoriaCABIMER (Andalusian Molecular Biology and Regenerative Medicine Centre), Seville, Spain.
Abdelkrim HmadchaCABIMER (Andalusian Molecular Biology and Regenerative Medicine Centre), Seville, Spain.
David PozoCABIMER (Andalusian Molecular Biology and Regenerative Medicine Centre), Seville, Spain.
Rafael Fernandez-MontesinosCABIMER (Andalusian Molecular Biology and Regenerative Medicine Centre), Seville, Spain.
Maria LealCABIMER (Andalusian Molecular Biology and Regenerative Medicine Centre), Seville, Spain.
Itziar OchotorenaCABIMER (Andalusian Molecular Biology and Regenerative Medicine Centre), Seville, Spain.
Patricia GálvezCABIMER (Andalusian Molecular Biology and Regenerative Medicine Centre), Seville, Spain.
Maria Angeles GenizServicio de Neurología, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
Francisco Javier BarónUnidad de Gestión Clínica de Neurociencias Clínicas, Servicio de Neurología y Servicio de Neurofisiología, Hospital Regional Universitario, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Malaga, Malaga, Spain.
Rosario MataAndalusian Initiative for Advanced Therapies, Junta de Andalucía, Seville, Spain.
Cristina MedinaAndalusian Initiative for Advanced Therapies, Junta de Andalucía, Seville, Spain.
Carlos Caparrós-EscuderoServicio de Radiodiagnóstico, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
Ana CardesaAndalusian Initiative for Advanced Therapies, Junta de Andalucía, Seville, Spain.
Natividad CuendeAndalusian Initiative for Advanced Therapies, Junta de Andalucía, Seville, Spain.
Research Group Study EudraCT 2008-004015-35
Centro Andaluz de Biología Molecular y Medicina Regenerativa · ESInstituto de Investigación Biomédica de Málaga · ESHospital Universitario Virgen Macarena · ESJunta de Andalucía · ESPublic Health Department · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrently available treatments for secondary progressive multiple sclerosis(SPMS) have limited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs) represent a promising option and can be readily obtained using minimally invasive procedures. PATIENTS AND

methodsIn this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product and followed for 12 months. Safety was monitored recording adverse events, laboratory parameters, vital signs and spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, and other measures of possible treatment effects were also recorded.

resultsThirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirty were infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were not infused because of karyotype abnormalities in the cell product. Only one serious adverse event was observed in the treatment arms (urinary infection, considered not related to study treatment). No other safety parameters showed changes. Measures of treatment effect showed an inconclusive trend of efficacy.

conclusionInfusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies and probably treatment at earlier phases would be needed to investigate the potential therapeutic benefit of this technique.

Indexed as

Mesenchymal Stem Cell TransplantationAdipose TissueAdultFeasibility StudiesFemaleHumansMaleMesenchymal Stem CellsMiddle AgedMultiple Sclerosis, Chronic ProgressiveTreatment Outcome

Identifiers

PMID29768414
PMCPMC5955528
OpenAlexW2804567596

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.