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

Multiple 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. A safety and...

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Published in:Journal of translational medicine Vol. 16; no. 1; p. 57
Main Authors: Riordan, Neil H, Morales, Isabela, Fernández, Giselle, Allen, Nicole, Fearnot, Neal E, Leckrone, Michael E, Markovich, Dedra Jones, Mansfield, Darla, Avila, Dorita, Patel, Amit N, Kesari, Santosh, Paz Rodriguez, Jorge
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Published: England BioMed Central Ltd 09-03-2018
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Abstract Multiple 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. A 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 UCMSC over 7 days. Efficacy was assessed at baseline, 1 month and 1 year after treatment, including magnetic resonance imaging (MRI) scans, Kurtzke Expanded Disability Status Scale (EDSS), Scripps Neurological Rating Scale, Nine-Hole Peg Test, 25-Foot Walk Test, and RAND Short Form-36 quality of life questionnaire. Twenty 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. Treatment 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.
AbstractList Abstract Background Multiple 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. Methods A 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 × 106 UCMSC over 7 days. Efficacy was assessed at baseline, 1 month and 1 year after treatment, including magnetic resonance imaging (MRI) scans, Kurtzke Expanded Disability Status Scale (EDSS), Scripps Neurological Rating Scale, Nine-Hole Peg Test, 25-Foot Walk Test, and RAND Short Form-36 quality of life questionnaire. Results Twenty 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. Conclusions Treatment 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
Multiple 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. A 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 UCMSC over 7 days. Efficacy was assessed at baseline, 1 month and 1 year after treatment, including magnetic resonance imaging (MRI) scans, Kurtzke Expanded Disability Status Scale (EDSS), Scripps Neurological Rating Scale, Nine-Hole Peg Test, 25-Foot Walk Test, and RAND Short Form-36 quality of life questionnaire. Twenty 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. Treatment 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.
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 × 106 UCMSC over 7 days. Efficacy was assessed at baseline, 1 month and 1 year after treatment, including magnetic resonance imaging (MRI) scans, Kurtzke Expanded Disability Status Scale (EDSS), Scripps Neurological Rating Scale, Nine-Hole Peg Test, 25-Foot Walk Test, and RAND Short Form-36 quality of life questionnaire. 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.
ArticleNumber 57
Audience Academic
Author Allen, Nicole
Leckrone, Michael E
Patel, Amit N
Markovich, Dedra Jones
Avila, Dorita
Morales, Isabela
Mansfield, Darla
Paz Rodriguez, Jorge
Fernández, Giselle
Kesari, Santosh
Riordan, Neil H
Fearnot, Neal E
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  surname: Riordan
  fullname: Riordan, Neil H
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  organization: MediStem Panama Inc., Clayton, City of Knowledge, Panama City, Panama. nhriordan@gmail.com
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  givenname: Isabela
  surname: Morales
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  givenname: Nicole
  surname: Allen
  fullname: Allen, Nicole
  organization: Cook Advanced Technologies, West Lafayette, IN, USA
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  surname: Fearnot
  fullname: Fearnot, Neal E
  organization: Cook Advanced Technologies, West Lafayette, IN, USA
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  organization: Cook Medical Technologies, Bloomington, IN, USA
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  surname: Markovich
  fullname: Markovich, Dedra Jones
  organization: Cook Advanced Technologies, West Lafayette, IN, USA
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  surname: Mansfield
  fullname: Mansfield, Darla
  organization: Cook Advanced Technologies, West Lafayette, IN, USA
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  givenname: Dorita
  surname: Avila
  fullname: Avila, Dorita
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  givenname: Amit N
  surname: Patel
  fullname: Patel, Amit N
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  givenname: Santosh
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– sequence: 12
  givenname: Jorge
  surname: Paz Rodriguez
  fullname: Paz Rodriguez, Jorge
  organization: Stem Cell Institute, Panama City, Panama
BackLink https://www.ncbi.nlm.nih.gov/pubmed/29523171$$D View this record in MEDLINE/PubMed
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Issue 1
Keywords Umbilical cord stem cells
Multiple sclerosis
Stem cell therapy
Multiple sclerosis treatment
Mesenchymal stem cells
Language English
License Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Snippet Multiple sclerosis (MS) is a progressively debilitating neurological condition in which the immune system abnormally erodes the myelin sheath insulating the...
BACKGROUNDMultiple sclerosis (MS) is a progressively debilitating neurological condition in which the immune system abnormally erodes the myelin sheath...
Abstract Background Multiple sclerosis (MS) is a progressively debilitating neurological condition in which the immune system abnormally erodes the myelin...
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Open Access Repository
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Index Database
StartPage 57
SubjectTerms Adult
Care and treatment
Development and progression
Diagnosis
Feasibility Studies
Female
Health aspects
Humans
Magnetic Resonance Imaging
Male
Mesenchymal Stem Cell Transplantation
Mesenchymal stem cells
Mesenchymal Stem Cells - cytology
Middle Aged
Multiple sclerosis
Multiple Sclerosis - diagnostic imaging
Multiple Sclerosis - therapy
Multiple sclerosis treatment
Stem cell therapy
Stem cells
Treatment Outcome
Umbilical cord
Umbilical Cord - cytology
Umbilical cord stem cells
Young Adult
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Title Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis
URI https://www.ncbi.nlm.nih.gov/pubmed/29523171
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https://pubmed.ncbi.nlm.nih.gov/PMC5845260
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