Trial Profile

Phase 2 Pivotal Registration Study Evaluating Laromestrocel for the Treatment of Pediatric Dilated Cardiomyopathy (DCM)

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 16 Jul 2025

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At a glance

16 Jul 2025 New trial record
08 Jul 2025 According to a Longeveron media release, Phase 2 clinical trial initiation anticipated in first half of 2026.
08 Jul 2025 According to a Longeveron media release, the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric dilated cardiomyopathy (DCM). The accepted IND application provides for moving directly to a single Phase 2 pivotal registration clinical trial.

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