Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461676
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-28
Brief Title:
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
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
Addressing these challenges ongoing clinical trials explore regenerative therapies particularly stem cell injections aiming to improve heart function Yet concerns persist regarding the practicality and efficacy of these treatments including issues with cell survival and coordination of injections within narrow timeframes
Innovatively the investigator and the team propose an alternative approach using VentriGel an injectable hydrogel derived from decellularized porcine myocardium Originally designed for treating heart failure post-myocardial infarction in adults VentriGel has shown promising results in animal models demonstrating significant improvements in cardiac function Notably its shelf-stable nature and flexible timing for administration offer advantages over traditional stem cell therapies
Moreover VentriGels effectiveness in addressing right-ventricular failure as demonstrated in recent studies highlights its potential as a solution for HLHS patients Leveraging approved extracellular matrix devices such as Alloderm and SurgiSIS further underscores the feasibility and safety of this approach paving the way for potentially transformative treatments in congenital heart diseases
Addressing these challenges ongoing clinical trials explore regenerative therapies particularly stem cell injections aiming to improve heart function Yet concerns persist regarding the practicality and efficacy of these treatments including issues with cell survival and coordination of injections within narrow timeframes
Innovatively the investigator and the team propose an alternative approach using VentriGel an injectable hydrogel derived from decellularized porcine myocardium Originally designed for treating heart failure post-myocardial infarction in adults VentriGel has shown promising results in animal models demonstrating significant improvements in cardiac function Notably its shelf-stable nature and flexible timing for administration offer advantages over traditional stem cell therapies
Moreover VentriGels effectiveness in addressing right-ventricular failure as demonstrated in recent studies highlights its potential as a solution for HLHS patients Leveraging approved extracellular matrix devices such as Alloderm and SurgiSIS further underscores the feasibility and safety of this approach paving the way for potentially transformative treatments in congenital heart diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None