Longeveron Inc. Announces Phase 2b Trial Results Published In Cell Stem Cell Showing Laromestrocel (LOMECEL-B®) Improved Physical Function In Frailty Patients At Nine Months

Longeveron Inc. announced that results from its Phase 2b clinical trial have been published in Cell Stem Cell, a Cell Press journal. The study showed that intravenous administration of laromestrocel, a mesenchymal stem cell therapy, led to measurable improvements in physical function in patients with age-related clinical frailty nine months after treatment when compared with placebo. The publication is now available on the Cell Stem Cell website. Laromestrocel (LOMECEL-B®) is Longeveron’s proprietary, scalable, allogeneic stem cell therapy currently being investigated for multiple conditions, including rare pediatric diseases and aging-related disorders.

According to Joshua M. Hare, MD, FACC, FAHA, Chief Science Officer at Longeveron, the trial results highlight the potential of stem cell therapy to support individuals living with aging-related frailty. He explained that patients with clinical frailty often struggle to manage routine and acute stressors and face higher risks of complications, illness, and poor surgical outcomes. He added that developing solutions for such vulnerable populations aligns closely with Longeveron’s mission to advance regenerative therapies that can address serious, life-threatening health challenges in both elderly individuals and children.

The Phase 2b study was a randomized, dose-finding clinical trial involving 148 ambulatory participants with frailty (NCT03169231). It evaluated whether laromestrocel, derived from human bone marrow-based allogeneic mesenchymal stem cells, could improve physical functioning and patient-reported outcomes. The findings showed clinically meaningful, dose- and time-dependent improvements in the 6-minute walk test (6MWT), the primary endpoint. 

Patients treated with laromestrocel demonstrated a 63.4-meter improvement at nine months (95% CI: 17.1–109.6 m; p=0.0077) and a 41.3-meter improvement at six months (95% CI: –2.4–84.9 m; p=0.0635) compared with placebo. Increased walking distance was also found to correlate with higher PROMIS Physical Function scores, indicating alignment between improved mobility and patient-reported physical capability.

Additionally, the study found that higher laromestrocel doses were associated with reductions in soluble TIE-2, the receptor for angiopoietins, suggesting a potential biomarker linked to treatment responsiveness. These combined findings point to a promising therapeutic approach for managing hypomobility and other features of aging-related frailty. They also support continued development of laromestrocel as a regenerative therapy aimed at addressing significant unmet medical needs in an aging population.