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.
Hypoplastic Left Heart Syndrome
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.
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial.
-
Children's Hospital of Los Angeles, Los Angeles, California, United States, 90027
Children's Hospital Colorado, Aurora, Colorado, United States, 80045
Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30322
Advocate Children's Hospital, Chicago, Illinois, United States, 60453
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611
Boston Children's Hospital, Boston, Massachusetts, United States, 02115
Children's Nebraska, Omaha, Nebraska, United States, 68114
Columbia University Irving Medical Center, New York, New York, United States, 10032
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
to 12 Months
ALL
No
Longeveron Inc.,
Stu Berger, MD, PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago
2025-08-31