Phase 2Active, not recruiting

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

Sponsor
Longeveron Inc. (Industry)
Enrolment
40 enrolled
Conditions
Hypoplastic Left Heart Syndrome
Interventions
Lomecel-B medicinal signaling cells
Ages
children
Registry
NCT04925024

From the registry

The purpose of this study is to test whether Lomecel-B™ works in treating patients with hypoplastic left heart syndrome (HLHS) and to gather additional information about the safety of Lomecel-B. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active ingredient. MSCs are special cells in the body that are able to change into other types of cells, such as heart, blood, and muscle cells. MSCs are found in various tissues of the body, such as the bone marrow, which is the spongy tissue inside of your bones. Lomecel-B uses MSCs from bone marrow of unrelated young healthy donors. These are called "allogeneic", and do not require donor matching to the patient.

Primary outcomes

  • Change in right ventricular ejection fraction (RVEF)
Full record on ClinicalTrials.gov