MIAMI, July 13, 2026
Longeveron announced new analyses from its Phase 2a CLEAR MIND clinical trial demonstrating that its investigational stem cell therapy laromestrocel (Lomecel-B®) reduced neuroinflammation in patients with mild Alzheimer’s disease. The findings were presented at the 2026 Alzheimer’s Association International Conference (AAIC) and showed that laromestrocel stabilized inflammation in key gray and white matter regions of the brain, as measured using advanced Free Water MRI imaging. According to the company, the results further support laromestrocel’s durable anti-inflammatory mechanism of action while identifying potential blood biomarkers associated with improved clinical outcomes. The latest findings build upon previously published Phase 2a data and strengthen the scientific rationale for advancing the therapy into Phase 3 clinical development. Longeveron also noted that its Alzheimer’s disease program has already received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration, with the company and FDA having aligned on a Phase 3 study design.
MRI Findings Demonstrate Reduced Brain Inflammation and Preservation of Brain Tissue
The new post-hoc exploratory analyses focused on evaluating changes in brain inflammation using Free Water MRI, an imaging biomarker associated with neuroinflammation and disease progression in Alzheimer’s disease. Investigators observed that patients receiving laromestrocel maintained stable free water levels in several critical Alzheimer’s disease brain regions, while placebo-treated patients experienced progressive increases in free water over the 39-week study period. The most pronounced anti-inflammatory effects were observed in the hippocampus, temporal lobe, and other regions commonly affected during Alzheimer’s disease progression. Importantly, reductions in free water correlated with increased brain volume, reduced brain atrophy, and improvements in cognitive performance and quality-of-life measures. The findings suggest that laromestrocel may help preserve brain tissue by mitigating the chronic inflammatory processes that contribute to neuronal degeneration and disease progression in patients with mild Alzheimer’s disease..
Blood Biomarkers Further Support Laromestrocel’s Mechanism of Action
In addition to neuroimaging results, researchers evaluated blood plasma biomarkers using NuLISA technology to better understand the biological effects of laromestrocel. Patients receiving treatment demonstrated reductions in neurogranin, a biomarker associated with neuronal damage and degeneration, while also showing increased levels of interleukin-13 (IL-13), an anti-inflammatory cytokine involved in regulating microglial activity within the brain. These biomarker changes were consistent with the MRI findings and further support the proposed anti-inflammatory and neuroprotective mechanism of action of laromestrocel. The Phase 2a CLEAR MIND trial evaluated multiple dosing regimens ranging from single-dose administration to repeated monthly infusions, with statistical analyses indicating consistent trends toward reduced neuroinflammation across treatment groups compared with placebo. Together, the imaging and biomarker findings provide converging evidence that laromestrocel may beneficially modify biological pathways involved in Alzheimer’s disease progression.
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Positive Data Strengthen Path Toward Phase 3 Alzheimer’s Development
The latest AAIC presentation further reinforces Longeveron’s strategy of developing regenerative cell therapies for neurodegenerative diseases with significant unmet medical needs. Laromestrocel is an investigational allogeneic mesenchymal stem cell therapy derived from the bone marrow of young healthy adult donors and is designed to exert anti-inflammatory, pro-vascular, regenerative, and tissue repair effects through multiple biological mechanisms. Previous Phase 2a CLEAR MIND results, published in Nature Medicine in 2025, demonstrated encouraging clinical findings that supported continued development of the therapy for mild Alzheimer’s disease. With new evidence showing reductions in neuroinflammation, preservation of brain structure, favorable biomarker changes, and correlations with improved clinical outcomes, Longeveron believes laromestrocel has the potential to become a novel disease-modifying therapy for Alzheimer’s disease. Supported by FDA RMAT and Fast Track designations and an agreed Phase 3 development pathway, the company plans to continue advancing the program while pursuing strategic partnerships to accelerate clinical development and bring the therapy closer to patients.
Source: Longeveron, press release
