NCT04925024

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Longeveron Inc. · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypoplastic Left Heart Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Lomecel-B medicinal signaling cells	A single administration of Lomecel-B will be performed via 6-10 intramyocardial injections into the right ventricle during the participant's standard of care stage II palliation. Dosing is based on body weight. Each patient will be given 2.5 x 10\^5 cells per kg of body weight. The entire dose of the cells will be roughly 600 microliters.

Timeline

• Start date: 2021-06-25
• Primary completion: 2026-06-30
• Completion: 2026-08-31
• First posted: 2021-06-14
• Last updated: 2025-06-25

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study