Evidence map›Paper›PMID 29523171›Full record

Trial reportJournal of translational medicine2018

Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis.

Neil H Riordan, Isabela Morales, Giselle Fernández, Nicole Allen, Neal E Fearnot, Michael E Leckrone, Dedra Jones Markovich, Darla Mansfield, Dorita Avila, Amit N Patel and 2 more

Erratum issued 2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 94 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 9 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.

NCT02034188 phase1 / phase2completednot on this map

Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis

TypeinterventionalSponsorTranslational BiosciencesRan2014 to 2016Enrolled20ConditionsMultiple SclerosisArmsUmbilical cord mesenchymal stem cells
NCT05003388 phase1recruitingnot on this mapstarted 2021, after this paper: background citation

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Multiple Sclerosis

TypeinterventionalSponsorThe Foundation for Orthopaedics and Regenerative MedicineRan2021 to 2025Enrolled15ConditionsMultiple SclerosisArmsAlloRx
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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34 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Neil H RiordanStem Cell Institute, Panama City, Panama. nhriordan@gmail.com.
Isabela MoralesMediStem Panama Inc., Clayton, City of Knowledge, Panama City, Panama.
Giselle FernándezStem Cell Institute, Panama City, Panama.
Nicole AllenCook Advanced Technologies, West Lafayette, IN, USA.
Neal E FearnotCook Advanced Technologies, West Lafayette, IN, USA.
Michael E LeckroneCook Medical Technologies, Bloomington, IN, USA.
Dedra Jones MarkovichCook Advanced Technologies, West Lafayette, IN, USA.
Darla MansfieldCook Advanced Technologies, West Lafayette, IN, USA.
Dorita AvilaMediStem Panama Inc., Clayton, City of Knowledge, Panama City, Panama.
Amit N PatelDepartment of Surgery, University of Miami School of Medicine, Miami, FL, USA.
Santosh KesariDepartment of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute and Pacific Neuroscience Institute, Santa Monica, CA, USA.
Jorge Paz RodriguezStem Cell Institute, Panama City, Panama.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultiple sclerosis (MS) is a progressively debilitating neurological condition in which the immune system abnormally erodes the myelin sheath insulating the nerves. Mesenchymal stem cells (MSC) have been used in the last decade to safely treat certain immune and inflammatory conditions.

methodsA safety and feasibility study was completed on the use of umbilical cord MSC (UCMSC) as a treatment for MS. In this 1-year study, consenting subjects received seven intravenous infusions of 20 × 10

resultsTwenty subjects were enrolled in this study. No serious adverse events were reported. Of the mild AEs denoted as possibly related to treatment, most were headache or fatigue. Symptom improvements were most notable 1 month after treatment. Improvements were seen in EDSS scores (p < 0.03), as well as in bladder, bowel, and sexual dysfunction (p < 0.01), in non-dominant hand average scores (p < 0.01), in walk times (p < 0.02) and general perspective of a positive health change and improved quality of life. MRI scans of the brain and the cervical spinal cord showed inactive lesions in 15/18 (83.3%) subjects after 1 year.

conclusionsTreatment with UCMSC intravenous infusions for subjects with MS is safe, and potential therapeutic benefits should be further investigated. Trial registration ClinicalTrials.gov NCT02034188. Registered Jan 13, 2014. https://clinicaltrials.gov/ct2/show/NCT02034188.

Indexed as

Mesenchymal Stem Cell TransplantationAdultFeasibility StudiesFemaleHumansMagnetic Resonance ImagingMaleMesenchymal Stem CellsMiddle AgedMultiple SclerosisTreatment OutcomeUmbilical CordYoung AdultMesenchymal stem cellsMultiple sclerosisMultiple sclerosis treatmentStem cell therapyUmbilical cord stem cells

Identifiers

PMID29523171
PMCPMC5845260

What OpenQuestion holds

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LicenceCC BY
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.