Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients with Hypoplastic Left Heart Syndrome (HLHS)
Emory University
Summary
The goal of this Phase I Open-Label study is to demonstrate the safety and feasibility of VentriGel injection in children with Hypoplastic Left Heart Syndrome (HLHS). The main questions it aims to answer are: * Whether VentriGel is safe in treating patients with HLHS * Whether there are any preliminary improvements in measures of cardiac function following Ventrigel injection
Description
HLHS, a type of congenital heart disease, presents a unique challenge where the left ventricle fails to develop, necessitating the right ventricle to manage both systemic and pulmonary blood flow. This condition, once fatal, has become manageable due to advancements in surgical techniques, with reported 5-year survival rates of 70-90%. However, these staged procedures, while lifesaving, can strain the right ventricle, leading to long-term issues such as weakened muscle and reduced cardiac function. Additionally, even with surgical intervention, patients often face a diminished quality of life.…
Eligibility
- Age range
- Up to 1 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects with Hypoplastic Left Heart Syndrome (HLHS) requiring Stage II Glenn operation under one year of age Exclusion Criteria: * Subjects undergoing the Stage II Glenn operations who do not have HLHS * Subjects requiring mechanical circulatory support within 5 days pre pre-surgical intervention * Parent or guardian unwilling or unable to comply with necessary follow-up(s) * Immunosuppressive diseases or subjects who require treatment with interventions that cause immunosuppression * A history of tumor or malignancy * Coagulation disorders * Chromosomal abnormalities…
Interventions
- DrugVentrix Bio Extracellular Matrix
VentriGel will be administered by injection into the right ventricle of the heart in the following defined doses per injection. There will be a total of 8 injections. The proposed dose of up to 0.6 mL is administered as up to 8 sequential injections of 4 injections of 0.1 mL each and 4 injections of 0.05 mL each.
Location
- Children's Healthcare of AltantaAtlanta, Georgia