Trial Profile

Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS) : A Phase IIb Clinical Trial

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 23 Sep 2026

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At a glance

16 Sep 2026 According to a Longeveron media release, the company is conducting additional analyses of the complete dataset and intends to discuss the results with the U.S. Food and Drug Administration (FDA) to determine potential next steps for the HLHS development program. FDA previously indicated its willingness to meet with the Company following completion of the study to discuss the results and potential paths forward.
16 Sep 2026 According to a Longeveron media release, primary endpoint (Change in right ventricular ejection fraction (RVEF)) has not been met.
16 Sep 2026 Results resented in the Longeveron media release.

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