drugset / Trial / NCT06461676
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)
Phase 1
Not yet recruiting
12 enrolled
Emory University
University of California, San Diego · collabVentrix, Inc. · collab
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2025-08
- Primary completion
- 2028-09
- Completion
- 2028-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ventrix Bio Extracellular Matrix | Other / unclassified | 0.05 ml | Other |
| Subject | Ventrix Bio Extracellular Matrix | Other / unclassified | 0.1 ml | Other |