Results and insights from a phase I clinical trial of Lomecel‐B for Alzheimer's disease
Résumé
Hypothesis We hypothesized that Lomecel‐B, an allogeneic medicinal signaling cell (MSC) therapeutic candidate for Alzheimer's disease (AD), is safe and potentially disease‐modifying via pleiotropic mechanisms of action. Key Predictions We prospectively tested the predictions that Lomecel‐B administration to mild AD patients is safe (primary endpoint) and would provide multiple exploratory indications of potential efficacy in clinical and biomarker domains (prespecified secondary/exploratory endpoints). Strategy and Key Results Mild AD patient received a single infusion of low‐ or high‐dose Lomecel‐B, or placebo, in a double‐blind, randomized, phase I trial. The primary safety endpoint was met. Fluid‐based and imaging biomarkers indicated significant improvement in the Lomecel‐B arms versus placebo. The low‐dose Lomecel‐B arm showed significant improvements versus placebo on neurocognitive and other assessments. Interpretation Our results support the safety of Lomecel‐B for AD, suggest clinical potential, and provide mechanistic insights. This early‐stage study provides important exploratory information for larger efficacy‐powered clinical trials.
Mots clés
Alzheimer disease
Lomecel-B
anti-inflammatory agents
biological therapy
bone marrow mesenchymal stem cell
clinical trial
cytokines
hippocampus
human bone marrow
inflammation
inflammation mediators
interleukins
medicinal signaling cell
mesenchymal stem cell
mesenchymal stromal cell
multipotent stem cells
neuroimaging
neuroinflammatory diseases
randomized controlled trial
regenerative medicine
vascular
vascular endothelial cell growth factor
Domaines
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