Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease.

ABSTRACT:

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

SUBMITTER: Brody M 

PROVIDER: S-EPMC10084163 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature