Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS)

Summary

This study is designed to assess the safety, tolerability, and efficacy of Lomecel-B as an adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS. Lomecel-B will be delivered via intramyocardial injections

Timeline

Start

2018-02-21

Primary completion

2024-06-30

Completion

2025-12-31

Outcome

Met primary endpoint

release “The results from the ELPIS I trial, which were previously reported, showed that the study met its primary safety endpoint” longeveron.com ↗

release “The results from the ELPIS I trial, which were previously reported, showed that the study met its primary safety endpoint” longeveron.com ↗

release “ELPIS I met its primary endpoint of safety through 1-year post-treatment” longeveron.com ↗

Publications

• Kaushal S, Hare JM, Hoffman JR, Boyd RM, Ramdas KN, Pietris N, Kutty S, Tweddell JS, Husain SA, Menon SC, Lambert LM, Danford DA, Kligerman SJ, Hibino N, Korutla L, Vallabhajosyula P, Campbell MJ, Khan A, Naioti E, Yousefi K, Mehranfard D, McClain-Moss L, Oliva AA, Davis ME. Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: the ELPIS phase I trial. Eur Heart J Open. 2023 Jan 11;3(2):oead002. doi: 10.1093/ehjopen/oead002. eCollection 2023 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesenchymal stem cell	Cell therapy	250000 cells/kg	Other

Indications