biostudies-literatureUnknown16Aguera-Morales E<h4>Introduction</h4>Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neurodegenerative disease with few treatments available. Mesenchymal stem cells have arisen as a potential treatment option for ALS due to their immune system modulation and their neuroprotective effects. This clinical trial aimed to evaluate the safety, efficacy and feasibility of three intravenous doses of autologous adipose-derived mesenchymal stem cells (AdMSC) in ALS patients.<h4>Methods</h4>A multicentre, randomized, parallel group, placebo-controlled, double-blinded clinical trial (EudraCT: 2011-006254-85) was conducted in 40 patients with ALS in treatment with riluzole. Patients were randomized 1:1:1:1 into the following treatment groups: 1 × 10⁶ cells/kg, 2 × 10⁶ cells/kg, 4 ×Frontiers in neurology1655124https://www.ebi.ac.uk/biostudies/studies/S-EPMC12540107biostudies-literatureAdipose-derived mesenchymal stem cells for the treatment of Amyotrophic Lateral Sclerosis. A phase I/II safety and efficacy clinical trial.PMC12540107Fernandez-Sanchez VEFernandez-Fernandez OCabezas-Rodriguez JATallon-Aguilar LSomoza-Ramirez MFernandez-Lopez OLopez-Ramirez CAguera-Morales EPadillo-Ruiz JPostigo-Pozo MJGeniz-Clavijo MAPena-Toledo MATinoco-Gonzalez JRodriguez-Acosta ANavarro-Mascarell GCarmona-Sanchez GQuijano-Ruiz BCaballero-Eraso CMacias-Sanchez MDMMarquez-Infante CMata Alcazar-Caballero RLeyva-Fernandez LReyes-Rodriguez VGarcia-Martin MLPatrignani-Ochoa GValladares-Sanchez AMaldonado-Sanchez RfalseAdipose-derived mesenchymal stem cells for the treatment of Amyotrophic Lateral Sclerosis. A phase I/II safety and efficacy clinical trial.<h4>Introduction</h4>Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neurodegenerative disease with few treatments available. Mesenchymal stem cells have arisen as a potential treatment option for ALS due to their immune system modulation and their neuroprotective effects. This clinical trial aimed to evaluate the safety, efficacy and feasibility of three intravenous doses of autologous adipose-derived mesenchymal stem cells (AdMSC) in ALS patients.<h4>Methods</h4>A multicentre, randomized, parallel group, placebo-controlled, double-blinded clinical trial (EudraCT: 2011-006254-85) was conducted in 40 patients with ALS in treatment with riluzole. Patients were randomized 1:1:1:1 into the following treatment groups: 1 × 10⁶ cells/kg, 2 × 10⁶ cells/kg, 4 ×2025-01-01T00:00:00Z20252026-06-10T03:10:07.069Z2026-06-10T03:07:16.773ZS-EPMC125401074113288610.3389/fneur.2025.1655124