---
title: "Mesenchymal Stem Cell Therapy in Multiple Sclerosis: Biomarker and Clinical Efficacy Systematic Re"
id: "pubmed-42764316"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42764316"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42764316/"
doi: "10.1007/s12035-026-06201-3"
published_at: "2026-09-21T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Mesenchymal Stem Cell Therapy in Multiple Sclerosis: Biomarker and Clinical Efficacy Systematic Re
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42764316
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42764316/)
- **DOI:** [10.1007/s12035-026-06201-3](https://doi.org/10.1007%2Fs12035-026-06201-3)
- **Published At:** 2026-09-21T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This systematic review evaluated the therapeutic effects of **mesenchymal stem cells (MSCs)** in multiple sclerosis (MS) with emphasis on biomarker responses, following PRISMA 2020 guidelines and database searches through January 3, 2026. - Seventeen publications representing 16 clinical trials were included: five randomized controlled trials (reported across six publications) and 11 non-randomized studies. - Extracted data encompassed MSC source, dose, route of administration, and multi-level outcomes including clinical, imaging, immunological, and objective biomarkers. - RCT results were inconsistent: a large intravenous bone marrow-derived MSC trial reported no EDSS improvement, while trials using **intrathecal** delivery or **umbilical cord-derived MSCs** suggested potential benefits in disability and functional tests (T25-FW, 9-HPT). - Biomarker findings were heterogeneous and often inconsistent; however, one RCT showed a significant reduction in cerebrospinal fluid **neurofilament light (NfL)** after intrathecal MSCs, implying a possible route-dependent neuroprotective effect. - Immunological marker data (for markers such as TNF-α and IL-17) were reported mainly in studies with high risk of bias and did not form a consistent pattern. - Across all included studies, **MSC therapy demonstrated an excellent safety profile** with no serious treatment-related adverse events reported. - The evidence base is limited by methodological heterogeneity, variable MSC sources and administration routes, short follow-up durations, and inconsistent biomarker selection and reporting. - Authors conclude that intrathecal and umbilical cord-derived approaches show tentative clinical and biomarker advantages but emphasize the need for standardized, larger RCTs and validation of biomarker predictive accuracy rather than simple expression changes. - Keywords emphasized in the review include **Biomarkers**, **Immunological markers**, **Mesenchymal stem cells**, **Multiple sclerosis**, **Neurofilament light**, **Progressive MS**, and **Regenerative medicine**.
## Clinical Analysis & Structured Key Points
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Affiliations Expand ### Affiliations * 1 Neuroscience Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. * 2 Department of Biochemistry and Molecular Biology, University of Chicago, Chicago, IL, USA. * 3 Health Science Research Fellow (Neurobiology), University of Pittsburgh, Pittsburgh, PA, USA. * 4 Innovative Medical Research Center, Faculty of Medicine, Mashhad Medical Sciences, Islamic Azad University, Mashhad, Iran. * 5 Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. * 6 Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. sahabnegahs@tums.ac.ir. * PMID: **42764316** * DOI: [ 10.1007/s12035-026-06201-3 ](https://doi.org/10.1007/s12035-026-06201-3) Item in Clipboard Review # Therapeutic Efficacy of Mesenchymal Stem Cells at the Level of Biomarkers in Multiple Sclerosis: A Systematic Review Shahrzad Najafi et al. Mol Neurobiol. 2026. Show details Display options Display options Format Abstract PubMed PMID Mol Neurobiol Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Mol+Neurobiol%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Mol+Neurobiol%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42764316/) . 2026 Sep 21;63(1):911. doi: 10.1007/s12035-026-06201-3. ### Authors [Shahrzad Najafi](https://pubmed.ncbi.nlm.nih.gov/?term=Najafi+S&cauthor_id=42764316)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42764316/#short-view-affiliation-1 "Neuroscience Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran."), [Parizad Najafi](https://pubmed.ncbi.nlm.nih.gov/?term=Najafi+P&cauthor_id=42764316)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42764316/#short-view-affiliation-1 "Neuroscience Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran."), [Mohammad Amin Bayat Tork](https://pubmed.ncbi.nlm.nih.gov/?term=Tork+MAB&cauthor_id=42764316)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42764316/#short-view-affiliation-2 "Department of Biochemistry and Molecular Biology, University of Chicago, Chicago, IL, USA."), [Sahar Ghorbanikalateh](https://pubmed.ncbi.nlm.nih.gov/?term=Ghorbanikalateh+S&cauthor_id=42764316)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42764316/#short-view-affiliation-3 "Health Science Research Fellow \(Neurobiology\), University of Pittsburgh, Pittsburgh, PA, USA."), [Sahel Ghorbanikalateh](https://pubmed.ncbi.nlm.nih.gov/?term=Ghorbanikalateh+S&cauthor_id=42764316)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42764316/#short-view-affiliation-3 "Health Science Research Fellow \(Neurobiology\), University of Pittsburgh, Pittsburgh, PA, USA."), [Fatemeh Ghorbani Saber](https://pubmed.ncbi.nlm.nih.gov/?term=Saber+FG&cauthor_id=42764316)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42764316/#short-view-affiliation-4 "Innovative Medical Research Center, Faculty of Medicine, Mashhad Medical Sciences, Islamic Azad University, Mashhad, Iran."), [Mohammad Ali Sahraian](https://pubmed.ncbi.nlm.nih.gov/?term=Sahraian+MA&cauthor_id=42764316)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42764316/#short-view-affiliation-5 "Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran."), [Sajad Sahab-Negah](https://pubmed.ncbi.nlm.nih.gov/?term=Sahab-Negah+S&cauthor_id=42764316)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42764316/#short-view-affiliation-6 "Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. sahabnegahs@tums.ac.ir.") ### Affiliations * 1 Neuroscience Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. * 2 Department of Biochemistry and Molecular Biology, University of Chicago, Chicago, IL, USA. * 3 Health Science Research Fellow (Neurobiology), University of Pittsburgh, Pittsburgh, PA, USA. * 4 Innovative Medical Research Center, Faculty of Medicine, Mashhad Medical Sciences, Islamic Azad University, Mashhad, Iran. * 5 Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. * 6 Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. sahabnegahs@tums.ac.ir. * PMID: **42764316** * DOI: [ 10.1007/s12035-026-06201-3 ](https://doi.org/10.1007/s12035-026-06201-3) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract Multiple sclerosis (MS), particularly progressive forms, remains a significant therapeutic challenge. Mesenchymal stem cell (MSC) therapy offers promising immunomodulatory and neuroprotective potential. This systematic review comprehensively evaluates the therapeutic efficacy and biomarker response to MSC therapy in MS. Following PRISMA 2020 guidelines, we searched PubMed, Scopus, Web of Science, and Embase up to January 3, 2026. Seventeen publications, corresponding to 16 distinct clinical trials (five unique randomized controlled trials [RCTs] reported in six publications, and 11 non-randomized studies), were included. Data on MSC sources, dosing, routes of administration, and multi-level outcomes (clinical, imaging, immunological, and objective biomarkers) were extracted. Quality was assessed using the Joanna Briggs Institute tools. Analysis of the included RCTs revealed divergent clinical efficacy. A large trial of intravenous bone marrow-derived MSCs showed no significant improvement in the Expanded Disability Status Scale (EDSS). In contrast, trials employing intrathecal (IT) administration or umbilical cord-derived MSCs reported potential benefits in disability and functional measures (e.g., T25-FW, 9-HPT). Biomarker analysis showed high inconsistency; however, IT MSC administration in one RCT was associated with a significant reduction in cerebrospinal fluid neurofilament light chain (NfL) levels, suggesting a route-dependent neuroprotective effect. Findings on immunological markers (e.g., TNF-α, IL-17) were derived predominantly from studies with a high risk of bias. Critically, MSC therapy demonstrated an excellent safety profile across all studies, with no serious treatment-related adverse events reported. MSC therapy demonstrates an excellent safety profile in MS. Intrathecal and umbilical cord-derived approaches show tentative clinical and biomarker benefits, especially concerning neuroprotection (NfL reduction). However, definitive conclusions are constrained by significant methodological heterogeneity and short follow-up periods across trials. Future research must focus on standardized, large-scale RCTs to optimize MSC source and administration route, and urgently needs to validate the predictive accuracy of biomarkers, beyond reporting only changes in expression levels. **Keywords:** Biomarkers; Immunological markers; Mesenchymal stem cells; Multiple sclerosis; Neurofilament light; Progressive MS; Regenerative medicine. © 2026. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declarations. Ethics Approval and Consent to Participate: Not applicable. This study is a systematic review of previously published literature and does not involve any new studies with human participants or animals performed by any of the authors. Consent for Publication: Not applicable. This manuscript does not contain any individual person’s data in any form (including images, videos, or case details). Conflict of interest: The authors declare no competing interests. ## Similar articles * [ Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. ](https://pubmed.ncbi.nlm.nih.gov/36321557/) Crider K, Williams J, Qi YP, Gutman J, Yeung L, Mai C, Finkelstain J, Mehta S, Pons-Duran C, Menéndez C, Moraleda C, Rogers L, Daniels K, Green P.Crider K, et al.Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217.Cochrane Database Syst Rev. 2022.Update in: [Cochrane Database Syst Rev. 2026 Feb 18;2:CD014217. doi: 10.1002/14651858.CD014217.pub2.](https://pubmed.ncbi.nlm.nih.gov/41705996/)PMID: 36321557Free PMC article.Updated. * [ Neuro-Behavioral Improvement and Mechanistic Pathways of Bone Marrow-Derived Mesenchymal Stem Cells and Exosomes in Experimental Multiple Sclerosis: A Systematic Review and Meta-analysis. ](https://pubmed.ncbi.nlm.nih.gov/41998337/) Kariminejad-Farsangi H, Kariminejad-Farsangi H, Sharifi M, Azh S, Ghadery Nasab Z, Dehghan-Kuroki M, Joushi S.Kariminejad-Farsangi H, et al.Cell Mol Neurobiol. 2026 Apr 17;46(1):96. doi: 10.1007/s10571-026-01715-9.Cell Mol Neurobiol. 2026.PMID: 41998337Free PMC article. * [ Safety and Efficacy of Mesenchymal Stem Cell Therapy in Aging Frailty: A Systematic Review. ](https://pubmed.ncbi.nlm.nih.gov/42737497/) Poutouri E, Sotiropoulou M, Potoupnis M, Koliakos G, Kassi E, Tournis S, Anagnostis P.Poutouri E, et al.Int J Mol Sci. 2026 Aug 25;27(17):7596. doi: 10.3390/ijms27177596.Int J Mol Sci. 2026.PMID: 42737497Free PMC article.Review. * [ Effect of intrathecal injection of mesenchymal stem cell-neural progenitors on cerebrospinal fluid biomarkers in progressive multiple sclerosis. ](https://pubmed.ncbi.nlm.nih.gov/42754254/) Harris VK, Jiang A, Ricciarini S, Jagid N, McCormick M, Kizilbash C, Sadiq SA.Harris VK, et al.Stem Cells Transl Med. 2026 Sep 18;15(10):szag083. doi: 10.1093/stcltm/szag083.Stem Cells Transl Med. 2026.PMID: 42754254 * [ Autologous cells derived from different sources and administered using different regimens for 'no-option' critical lower limb ischaemia patients. ](https://pubmed.ncbi.nlm.nih.gov/30155883/) Abdul Wahid SF, Ismail NA, Wan Jamaludin WF, Muhamad NA, Abdul Hamid MKA, Harunarashid H, Lai NM.Abdul Wahid SF, et al.Cochrane Database Syst Rev. 2018 Aug 29;8(8):CD010747. doi: 10.1002/14651858.CD010747.pub2.Cochrane Database Syst Rev. 2018.PMID: 30155883Free PMC article. [ See all similar articles ](https://pubmed.ncbi.nlm.nih.gov/?linkname=pubmed_pubmed&from_uid=42764316) ## References 1. 1. Kråkenes T, Wergeland S, Al-Sharabi N, Mohamed-Ahmed S, Fromreide S, Costea D-E et al (2023) The neuroprotective potential of mesenchymal stem cells from bone marrow and human exfoliated deciduous teeth in a murine model of demyelination. PLoS ONE 18(11):e0293908 - [DOI](https://doi.org/10.1371/journal.pone.0293908) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/37943848/) - [PMC](https://pmc.ncbi.nlm.nih.gov/articles/10635499/) 2. 1. Comabella M, Khoury SJ (2012) Immunopathogenesis of multiple sclerosis. Clin Immunol 142(1):2–8 - [DOI](https://doi.org/10.1016/j.clim.2011.03.004) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/21458377/) 3. 1. Manche S, Probst Y (2023) Exploring the socio-ecological factors impacting lifestyle management of multiple sclerosis: a scoping review. Mult Scler Relat Disord 79:104958 - [DOI](https://doi.org/10.1016/j.msard.2023.104958) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/37708822/) 4. 1. Jones JL, Coles AJ (2010) New treatment strategies in multiple sclerosis. Exp Neurol 225(1)
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