Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial.
Running, not enrolling · Phase 2
Conditions studied: Hypoplastic Left Heart Syndrome
In brief
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.
Key facts
- Study ID
- NCT04925024
- Run by
- Longeveron Inc.
- People needed
- 40
- Starts
- 2021-06-25
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2025-06-25
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital of Los Angeles — Los Angeles, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- Advocate Children's Hospital — Chicago, Illinois, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Children's Nebraska — Omaha, Nebraska, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Primary Children's Hospital/University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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