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

Journal of Translational Medicine

Neal E. Fearnot¹  Dedra Jones Markovich¹  Darla Mansfield¹  Nicole Allen¹  Michael E. Leckrone²  Amit N. Patel³  Santosh Kesari⁴  Isabela Morales⁵  Dorita Avila⁵  Giselle Fernández⁶  Neil H. Riordan⁶  Jorge Paz Rodriguez⁶ 

[1] Cook Advanced Technologies;Cook Medical Technologies;Department of Surgery, University of Miami School of Medicine;Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute and Pacific Neuroscience Institute;MediStem Panama Inc.;Stem Cell Institute;

关键词: Multiple sclerosis;    Umbilical cord stem cells;    Stem cell therapy;    Multiple sclerosis treatment;    Mesenchymal stem cells;   

DOI  :  10.1186/s12967-018-1433-7

来源: DOAJ

【 摘 要 】

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

【 授权许可】

Unknown