Longeveron Phase 2b Trial Shows Stem Cell Therapy Improved Age-Related Frailty

Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative cell therapy for life-threatening rare pediatric and chronic aging-related conditions, announced that results of its Phase 2b clinical trial were published on February 25, 2026 in Cell Stem Cell, a Cell Press Journal. The Phase 2b results demonstrated that intravenous laromestrocel, a mesenchymal stem cell product, improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo.

The Phase 2b, randomized, dose-finding clinical trial evaluated whether laromestrocel, human bone marrow-derived allogeneic MSCs, improves physical functioning and patient self-reported outcomes in 148 ambulatory individuals with frailty (NCT03169231). Laromestorcel infusions resulted in clinically meaningful, dose-and time-dependent increases in the primary endpoint of the 6-minute walk test (6MWT) compared with placebo: 63.4m (95% confidence interval [CI]: 17.1-109.6m; p=0.0077) at month 9 and 41.3m (95% CI: -2.4-84.9m; p=0.0635) at month 6. Increased 6MWT distance correlates with PROMIS Physical Function score. Increasing doses of laromestrocel are associated with decreases in soluble (degraded) tyrosine kinase with immunoglobulin and epidermal growth factor homology domains (TIE-2), the cognate receptor for the angiopoietins, identifying a potential biomarker for laromestrocel responsiveness.

These findings identify a possible stem cell therapy approach for the management of patients with hypomobility and other features of aging frailty. The Chief Science Officer stated that those with Aging Frailty are disproportionately compromised in their ability to cope with every day and acute stressors, are at high vulnerability to disease and injury, and are at increased risk for poor outcomes and death after surgery.

Laromestrocel (LOMECEL-B®) is a proprietary, scalable, allogeneic stem cell (MSC) investigational therapy that is currently being evaluated in multiple indications. The therapy is an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas.

Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease (AD), and Pediatric Dilated Cardiomyopathy (DCM). Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation.