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

Mark Brody, Marc Agronin, Brad J. Herskowitz, Susan Y. Bookheimer, Gary W. Small, Benjamin Hitchinson, Kevin Ramdas, Tyler Wishard, Katalina Fernández McInerney, Bruno Vellas, Felipe Sierra, Zhijie Jiang, Lisa Mcclain-Moss, Carmen Perez, Ana Fuquay, Savannah Rodriguez, Joshua M. Hare, Anthony A. Oliva, Bernard Baumel

Research output: Contribution to journalArticlepeer-review

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 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.

Original languageEnglish (US)
JournalAlzheimer's and Dementia
DOIs
StateAccepted/In press - 2022
Externally publishedYes

Keywords

  • 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

ASJC Scopus subject areas

  • Epidemiology
  • Health Policy
  • Developmental Neuroscience
  • Clinical Neurology
  • Geriatrics and Gerontology
  • Psychiatry and Mental health
  • Cellular and Molecular Neuroscience

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