Background: Alzheimer's disease (AD) is characterized by progressive atrophy of the cerebral cortex and hippocampus, with concomitant increase in ventricular volume. Lomecel-B is a novel cell-based therapeutic approach to AD that targets neuroinflammation, microvascular dysfunction, and has the potential to stimulate endogenous tissue regeneration. We conducted MRI analysis of brain morphology in the CLEAR-MIND study, a 49-patient proof-of-concept study that tested 3 different dosing regimens of Lomecel-B vs placebo in patients with mild AD dementia.
View Article and Find Full Text PDFBackground: Lomecel-B is a novel cell-based therapy with potential to demonstrate clinical benefit on Alzheimer's disease (AD) and its progression. Here we present the results of a phase 2a proof-of-concept trial (n = 49) to further define the potential of Lomecel-B in patients with mild AD dementia.
Methods: This double-blind, randomized, placebo-controlled 45-week trial (ClinicalTrials.
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.
A woman who was 30 weeks pregnant was given terbutaline sulfate to prevent premature labor contractions. Within several days, she had an acute paraparesis with myalgias and was unable to walk. Full neurologic investigation failed to show any obvious cause.
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