Clinical trial

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

Name

2021-4531

Description

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.

Trial arms

Trial start

2021-06-25

Estimated PCD

2025-03-01

Trial end

2025-08-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Lomecel B Group

Size

Primary endpoint

Change in right ventricular ejection fraction (RVEF)

Baseline, 12 Months

Eligibility criteria

Inclusion: All participants must have HLHS (includes all types) requiring Stage II palliation (Glenn or Hemi-Fontan operation). Exclusion: 1. Requirement for ongoing mechanical circulatory support immediately prior to Stage II palliation within 5 days 2. Need for concomitant surgery for aortic coarctation or tricuspid valve repair or Endocardial fibroelastosis (EFE) resection or left ventricle recruitment procedures 3. Undergoing the Stage I (Norwood) procedure that does not have HLHS 4. Serum positivity for: human immunodeficiency virus (HIV); hepatitis B virus surface antigen (HBV BsAg); and/or viremic hepatitis C virus (HCV). This criterion can be ascertained by one of three ways: 1. Documented history of mother's testing conducted during pregnancy 2. Documented history of participants testing. 3. If above documentation is not available blood will be obtained from participant at Screening/Baseline. 5. Parent/guardian that is unwilling or unable to comply with necessary follow-up 6. Unsuitability for the study based on the Investigator's clinical opinion 7. Known hypersensitivity to dimethyl sulfoxide (DMSO) 8. Presence of a pacemaker, or anticipated placement of a pacemaker, at the time of the Stage II palliation

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 38, 'type': 'ESTIMATED'}}

Updated at

2024-04-09

1 organization

Organization

Longeveron