Cell stem cellFeb 26, 2026

Stem cell treatment with laromestrocel for aging frailty tested at different doses in a phase 2b trial

Longevity & Aging Weekly Brief ↗PubMed ↗DOI ↗

Updated Jun 27, 2026

Abstract

Essence

Laromestrocel improved 9-month walking distance in ambulatory people with aging frailty in a phase 2b trial.

Evidence

Randomized dose-finding clinical trial evidence in 148 frail ambulatory participants compared allogeneic mesenchymal stem cell infusion with placebo and found a 63.4 m 6MWT difference at month 9.

Caveat

The month 6 6MWT confidence interval crossed zero, and this dose-finding trial used functional and self-reported outcomes rather than definitive clinical events.

Simplified

Frailty, a syndrome that decreases healthspan in older individuals, lacks effective therapies. We conducted a randomized, dose-finding clinical trial to test whether human bone marrow-derived allogeneic mesenchymal stem cells (MSCs; laromestrocel) improve physical functioning and patient self-reported outcomes in ambulatory individuals with frailty (ClinicalTrials.gov #NCT03169231; N = 148). Laromestrocel infusion results in clinically meaningful, dose- and time-dependent increases in the 6-min walk test (6MWT; primary endpoint) compared with placebo: 63.4 m (95% confidence interval [CI]: 17.1-109.6 m; p = 0.0077) at month 9 and 41.3 m (95% CI: -2.4-84.9 m; p = 0.0635) at month 6. Increased 6MWT distance correlates with PROMIS Physical Function score, and increasing doses of laromestrocel are associated with decreases in soluble (degraded) tyrosine kinase with immunoglobulin and epidermal growth factor homology domains (TIE2), the cognate receptor for the angiopoietins, identifying a potential biomarker of laromestrocel responsiveness. These findings identify a stem cell therapy approach for the management of patients with hypomobility and other features of aging frailty.