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Preprints

Evaluation of Safety and Efficacy of Repeated Mesenchymal Stem Cell Transplantations in ALS Patients by Investigating Patient's Specific Immunological and Biochemical Biomarkers: A Retrospective study.

Alkhazaali Z, Sahab-Negah S, Boroumand AR, Kaffash N, Khodadoust MA, Afshari JT.
Preprint from
Preprints.org
26 March 2024
PPR
PPR829012
Abstract

Background:

Amyotrophic lateral sclerosis (ALS) is an incurable disease. There are no defined valid biomarkers for evaluating therapeutic outcomes of this disease. Numerous approaches have been made to meet this impact. Stem cells, one of these approaches, that might give various hopeful results that can be interpreted as a treatment for ALS This study aims to evaluate Mesenchymal Stem Cell (MSC) therapy as a promising novel treatment modality by estimating some parameters, such as immunological and biochemical factors.

Methods:

This study course involved 15 confirmed patients with ALS and was designed as an open-label, one-arm retrospective study to evaluate potential diagnostic biomarkers of repeated infusions of autologous bone marrow-derived mesenchymal stem cells (BM-MSC) administered at a dose of 1×106cells/kg BW with 1-month interval, in equal amounts in both intravenous (IV) and intrathecal (IT) simultaneously, by various biochemical and immunological parameters were evaluated during the three-month follow-up period.

Results:

Our study indicated that in the case of Immunological biomarkers ,Tumor Necrosis Factor-alpha (TNF-α) levels in the Cerebrospinal fluid (CSF) showed a significant decrease at month three after transplantation compared to levels at month zero, and the P-value was (P<0.01). No statistically significant changes were observed for other immunological and biochemical parameters and P-value (P>0.05).

Conclusions:

These results can indicate the benefit of stem cell transfusion in patients with ALS and suggest some diagnostic biomarkers. Several studies are required to approve these results.