Testing Lomecel-B™ for treating Hypoplastic Left Heart Syndrome in children
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS) : A Phase IIb Clinical Trial.
This study is testing if a new treatment using stem cells can help children with Hypoplastic Left Heart Syndrome feel better and improve their heart function after a specific surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Longeveron Inc. Industry-sponsored |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Trial ID | NCT04925024 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of Lomecel-B™, which contains human mesenchymal stem cells, in treating pediatric patients with Hypoplastic Left Heart Syndrome (HLHS) who require Stage II palliation. The study aims to determine if these stem cells can improve heart function and overall outcomes for these patients. Participants will receive Lomecel-B™ injections, and the trial will monitor their health and response to the treatment. The stem cells used are allogeneic, meaning they come from healthy young donors and do not require matching with the patient.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with HLHS who are scheduled for Stage II palliation.
Not a fit: Patients who require immediate mechanical circulatory support or have other significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for children with HLHS.
How similar studies have performed: While the use of stem cells in cardiac conditions is being explored, this specific approach with Lomecel-B™ in HLHS is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 11 other locations
- Children's Hospital of Los Angeles — Los Angeles, California, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Advocate Children's Hospital — Chicago, Illinois, United States (Terminated)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Children's Nebraska — Omaha, Nebraska, United States (Recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Withdrawn)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Terminated)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- UTHealth-McGovern Medical School — Houston, Texas, United States (Withdrawn)
- Primary Children's Hospital/University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Stu Berger, MD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Stephanie Brazis, MPH
- Email: sbrazis@luriechildrens.org
- Phone: 312-227-0201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.