Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial. (ELPISII)
Hypoplastic Left Heart Syndrome
About this trial
This is an interventional treatment trial for Hypoplastic Left Heart Syndrome focused on measuring Hypoplastic Left Heart Syndrome, Pediatrics, Heart Defects, Congenital Cardiovascular Diseases, Stem Cells
Eligibility Criteria
Inclusion:
All participants must have HLHS (includes all types) requiring Stage II palliation (Glenn or Hemi-Fontan operation).
Exclusion:
- Requirement for ongoing mechanical circulatory support immediately prior to Stage II palliation within 5 days
- Need for concomitant surgery for aortic coarctation or tricuspid valve repair or Endocardial fibroelastosis (EFE) resection or left ventricle recruitment procedures
- Undergoing the Stage I (Norwood) procedure that does not have HLHS
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:
- Documented history of mother's testing conducted during pregnancy
- Documented history of participants testing.
- If above documentation is not available blood will be obtained from participant at Screening/Baseline.
- Parent/guardian that is unwilling or unable to comply with necessary follow-up
- Unsuitability for the study based on the Investigator's clinical opinion
- Known hypersensitivity to dimethyl sulfoxide (DMSO)
- Presence of a pacemaker, or anticipated placement of a pacemaker, at the time of the Stage II palliation
Sites / Locations
- Children's Hospital of Los AngelesRecruiting
- Children's Healthcare of AtlantaRecruiting
- Advocate Children's HospitalRecruiting
- Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
- Boston Children's HospitalRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- UTHealth-McGovern Medical SchoolRecruiting
- Primary Children's Hospital/University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Lomecel B Group
No Study Intervention Control Group
Participants randomized to receive Lomecel-B injections during their Stage II palliation.
Participants randomized to receive no study intervention during their Stage II palliation.