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)
Launched by EMORY UNIVERSITY · Jun 14, 2024
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called VentriGel for children with Hypoplastic Left Heart Syndrome (HLHS), a serious heart condition where the left side of the heart doesn't develop properly. The main goal of this study, which is in its early phase, is to find out if VentriGel is safe for these young patients and if it can help improve their heart function after being injected.
To be eligible for the trial, children must be younger than one year old and scheduled for a specific heart surgery called the Stage II Glenn operation. Unfortunately, not all children with HLHS can participate; those with certain health issues or other serious conditions will be excluded for their safety. If a child is chosen to take part, their family can expect regular check-ups and monitoring to ensure everything goes well during and after the treatment. This trial is an exciting opportunity to explore new ways to help improve heart health in young patients with HLHS.
Gender
ALL
Eligibility criteria
- 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 that limit expected survival to \< 1 year
- • Abnormal lab values that may increase the risk of the study procedure (WBC \>20,000 cells/ul or \< 1,000 cells/ul; platelet count \< 50,000 cells/ul; Hgb \< 8.0 gm/dl; LFTs \> 2x reference lab upper limit of normal) at the time of screening
- • Subjects with conduction abnormalities, including atrioventricular block and bundle branch blocks
- • Ventricular arrhythmias due to antiarrhythmic pharmacological therapy
About Emory University
Emory University, a leading research institution located in Atlanta, Georgia, is dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Emory harnesses the expertise of its renowned faculty and state-of-the-art facilities to conduct cutting-edge research across various fields, including oncology, neurology, and infectious diseases. The university's commitment to ethical research practices and patient safety ensures that all clinical trials are designed to generate valuable data that can lead to significant therapeutic advancements. By fostering partnerships with local hospitals and community organizations, Emory strives to translate research findings into real-world applications, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
Patients applied
Trial Officials
William Mahle, MD
Principal Investigator
Emory University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported