Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease.
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
Journal
Alzheimer's & dementia : the journal of the Alzheimer's Association
ISSN: 1552-5279
Titre abrégé: Alzheimers Dement
Pays: United States
ID NLM: 101231978
Informations de publication
Date de publication:
01 2023
01 2023
Historique:
revised:
10
02
2022
received:
07
06
2021
accepted:
12
02
2022
pubmed:
1
4
2022
medline:
18
1
2023
entrez:
31
3
2022
Statut:
ppublish
Résumé
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. 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). 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. 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.
Identifiants
pubmed: 35357079
doi: 10.1002/alz.12651
pmc: PMC10084163
doi:
Substances chimiques
Biomarkers
0
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
261-273Informations de copyright
© 2022 Longeveron Inc. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Wiley Periodicals LLC.
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