Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty

Summary

This is a randomized, placebo-controlled, double-blind, parallel arm, multi-center Phase 2b study.

Timeline

Start

2017-07-06

Primary completion

2021-09-30

Completion

2021-09-30

Outcome

Met primary endpoint

paper 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) PMID 41747733 ↗

release “Aging Frailty Phase 2b Trial Data -- National Institute on Aging-funded study showed significant, dose-dependent improvement in walking distance” longeveron.com ↗

release “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” longeveron.com ↗

Publications

• Ruiz JG, Oliva AA Jr, Ramdas KN, Javier J, Rosen J, Perry R, Blanco A, Ylisastigui P, Walston J, Arai H, Volpi E, Newman AB, Varnado B, McClain-Moss L, Naioti E, Mehranfard D, Gincel D, Wang C, Mintzer MJ, Danisi J, Green GA, Botbyl J, Zainul Z, Rash BG, Hare JM. Randomized phase 2b dose-escalation trial of stem cell therapy with laromestrocel for aging frailty. Cell Stem Cell. 2026 Mar 5;33(3):393-404.e4. doi: 10.1016/j.stem.2026.01.017. Epub 2026 Feb 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesenchymal stem cell	Cell therapy	25 cells	Intravenous
Subject	Mesenchymal stem cell	Cell therapy	50 cells	Intravenous
Subject	Mesenchymal stem cell	Cell therapy	100 cells	Intravenous
Subject	Mesenchymal stem cell	Cell therapy	200 cells	Intravenous

Indications

No indication recorded.