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 |
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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. |
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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 |
Author_xml | – sequence: 1 givenname: Neil H surname: Riordan fullname: Riordan, Neil H email: nhriordan@gmail.com, nhriordan@gmail.com organization: MediStem Panama Inc., Clayton, City of Knowledge, Panama City, Panama. nhriordan@gmail.com – sequence: 2 givenname: Isabela surname: Morales fullname: Morales, Isabela organization: MediStem Panama Inc., Clayton, City of Knowledge, Panama City, Panama – sequence: 3 givenname: Giselle surname: Fernández fullname: Fernández, Giselle organization: Stem Cell Institute, Panama City, Panama – sequence: 4 givenname: Nicole surname: Allen fullname: Allen, Nicole organization: Cook Advanced Technologies, West Lafayette, IN, USA – sequence: 5 givenname: Neal E surname: Fearnot fullname: Fearnot, Neal E organization: Cook Advanced Technologies, West Lafayette, IN, USA – sequence: 6 givenname: Michael E surname: Leckrone fullname: Leckrone, Michael E organization: Cook Medical Technologies, Bloomington, IN, USA – sequence: 7 givenname: Dedra Jones surname: Markovich fullname: Markovich, Dedra Jones organization: Cook Advanced Technologies, West Lafayette, IN, USA – sequence: 8 givenname: Darla surname: Mansfield fullname: Mansfield, Darla organization: Cook Advanced Technologies, West Lafayette, IN, USA – sequence: 9 givenname: Dorita surname: Avila fullname: Avila, Dorita organization: MediStem Panama Inc., Clayton, City of Knowledge, Panama City, Panama – sequence: 10 givenname: Amit N surname: Patel fullname: Patel, Amit N organization: Department of Surgery, University of Miami School of Medicine, Miami, FL, USA – sequence: 11 givenname: Santosh surname: Kesari fullname: Kesari, Santosh organization: Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute and Pacific Neuroscience Institute, Santa Monica, CA, USA – sequence: 12 givenname: Jorge surname: Paz Rodriguez fullname: Paz Rodriguez, Jorge organization: Stem Cell Institute, Panama City, Panama |
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Keywords | Umbilical cord stem cells Multiple sclerosis Stem cell therapy Multiple sclerosis treatment Mesenchymal stem cells |
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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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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 |
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