PreprintArticleVersion 1Preserved in Portico This version is not peer-reviewed
Evaluation of Safety and Efficacy of Repeated Mesenchymal Stem Cell Transplantation in Patients with ALS by Investigating Patient's Specific MicroRNAs as Novel Biomarkers: A Retrospective Study
Version 1
: Received: 29 March 2024 / Approved: 3 April 2024 / Online: 3 April 2024 (14:25:24 CEST)
How to cite:
Alkhazaali, Z.; Sahab-Negah, S.; Boroumand, A.R.; Farkhad, N.K.; Khodadoust, M.A.; Ganjali, R.; Tavakol-Afshari, J. Evaluation of Safety and Efficacy of Repeated Mesenchymal Stem Cell Transplantation in Patients with ALS by Investigating Patient's Specific MicroRNAs as Novel Biomarkers: A Retrospective Study. Preprints2024, 2024040301. https://doi.org/10.20944/preprints202404.0301.v1
Alkhazaali, Z.; Sahab-Negah, S.; Boroumand, A.R.; Farkhad, N.K.; Khodadoust, M.A.; Ganjali, R.; Tavakol-Afshari, J. Evaluation of Safety and Efficacy of Repeated Mesenchymal Stem Cell Transplantation in Patients with ALS by Investigating Patient's Specific MicroRNAs as Novel Biomarkers: A Retrospective Study. Preprints 2024, 2024040301. https://doi.org/10.20944/preprints202404.0301.v1
Alkhazaali, Z.; Sahab-Negah, S.; Boroumand, A.R.; Farkhad, N.K.; Khodadoust, M.A.; Ganjali, R.; Tavakol-Afshari, J. Evaluation of Safety and Efficacy of Repeated Mesenchymal Stem Cell Transplantation in Patients with ALS by Investigating Patient's Specific MicroRNAs as Novel Biomarkers: A Retrospective Study. Preprints2024, 2024040301. https://doi.org/10.20944/preprints202404.0301.v1
APA Style
Alkhazaali, Z., Sahab-Negah, S., Boroumand, A.R., Farkhad, N.K., Khodadoust, M.A., Ganjali, R., & Tavakol-Afshari, J. (2024). Evaluation of Safety and Efficacy of Repeated Mesenchymal Stem Cell Transplantation in Patients with ALS by Investigating Patient's Specific MicroRNAs as Novel Biomarkers: A Retrospective Study. Preprints. https://doi.org/10.20944/preprints202404.0301.v1
Chicago/Turabian Style
Alkhazaali, Z., Rashin Ganjali and Jalil Tavakol-Afshari. 2024 "Evaluation of Safety and Efficacy of Repeated Mesenchymal Stem Cell Transplantation in Patients with ALS by Investigating Patient's Specific MicroRNAs as Novel Biomarkers: A Retrospective Study" Preprints. https://doi.org/10.20944/preprints202404.0301.v1
Abstract
Background: Since there is no cure for amyotrophic lateral sclerosis (ALS) currently, it is very important for searching diagnostic biomarkers and novel treatments to reduce the severity of this disease; one of these treatment approaches is stem cell transplantation. This study aims to evaluate the safety and efficacy of repeated transplantation of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) in patients with ALS by analyzing molecular data. Methods: In this single-centre, open-label, phase II clinical trial, retrospective study, fifteen confirmed ALS patients entered the study based on defined inclusion and exclusion criteria and underwent repeated stem cell transplantation (3 times BM-MSCs transplantation (1×10^6) , MSC/Kg BW per injection) concurrently intrathecally (IT) and intravenously (IV), with one-month interval). Clinical assessment of molecular investigation by evaluating specific microRNAs expression (Mir206, 133a-3p, 338-3p) in the patient's serum and Cerebra spinal fluid (CSF) samples were done three times during the 3-month follow-up. Statistical analysis includes paired T-test or Wilcoxon signed ranks. Results: No serious adverse effects were reported following stem cell transplantation. Besides, the mentioned microRNA expression slightly increased but still non-significant (P>0.05). Conclusions: Although Our study demonstrated non-signifying results. However, the still increasing of these MircRNAs in serum and CSF overall, can indicate that repeated transplantation of BM-MSCs was a safe procedure in ALS patients, leading to delay in disease progression and improvement in clinical symptoms. Future studies are needed to confirm these results.
Medicine and Pharmacology, Neuroscience and Neurology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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