Clinical trials: Hypoplastic Left Heart Syndrome (HLHS)
HLHS
Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS)
This study is designed to assess the safety, tolerability, and efficacy of Lomecel-B as an adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS. Lomecel-B will be delivered via intramyocardial injections
- Trial name
- ELPIS (NCT03525418)
- Testing
- Longeveron Mesenchymal Stem Cells
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Longeveron Inc.
Heart Defects
Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type
The purpose of this study is to compare direct and indirect measures of right ventricular (RV) systolic and diastolic function between 11 year old subjects who had been randomly assigned to receive a right ventricle to pulmonary…
- Trial name
- SVRIII (NCT02455531)
- Volunteers
- 237 people
- Sponsor
- Carelon Research
Hypoplastic Left Heart Syndrome
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)
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).
- Trial name
- NCT06461676
- Testing
- Ventrix Bio Extracellular Matrix
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
Hypoplastic Left Heart Syndrome, Heart Defects, Congenital
Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery
This study aims to evaluate the safety and feasibility of coronary infusion of autologous placental cord blood mononuclear cells during the Norwood heart operation in newborn hypoplastic left heart syndrome (HLHS) patients.
- Conditions
- Hypoplastic Left Heart Syndrome, Heart Defects, Congenital, Pediatric Disorder
- Trial name
- NCT03431480
- Testing
- Autologous Human Placental Cord Blood Mononuclear Cells
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Murdoch Childrens Research Institute
Hypoplastic Left Heart Syndrome
Positive Pressure Ventilation and Sternal Closure in HLHS
This study will examine the cardiopulmonary interactions that occur with increasing ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left heart syndrome before and after sternal closure.
- Trial name
- NCT02455713
- Testing
- PEEP and PIP
- Where
- Canada
- Sponsor
- The Hospital for Sick Children
Hypoplastic Left Heart Syndrome
Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with…
- Trial name
- NCT03779711
- Testing
- Autologous (self) mononuclear cells derived from umbilical cord blood, Stage II Surgical repair
- Where
- 8 sites in United States
- Volunteers
- 95 people
- Sponsor
- Timothy J Nelson, MD, PhD
Congenital Heart Disease, Coarctation of Aorta
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative…
- Conditions
- Congenital Heart Disease, Coarctation of Aorta, Aortic Stenosis, Pulmonary Atresia
- Trial name
- NCT06768008
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Beijing Anzhen Hospital
Hypoplastic Left Heart, Congenital Heart Disease
Use of Oxandrolone to Promote Growth in Infants With HLHS
The primary aim of this study is to determine if clinically relevant doses of buccally administered oxandrolone are safe and tolerable in neonates with hypoplastic left heart syndrome (HLHS) or other single right ventricular…
- Trial name
- NCT04090697
- Testing
- Oxandrolone
- Where
- 10 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Carelon Research
Congenital Heart Disease, SRV Dependent
Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
Researchers want to better understand what happens to the heart when the autologous (from one's own body) stem cells are injected directly into muscle of the right side of the heart during the Fontan (Stage III) surgery.
- Trial name
- NCT04907526
- Testing
- Autologous mononuclear cells
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Timothy J Nelson, MD, PhD
Congenital Heart Disease
The Co-Op @ HeartWorks
This protocol is a research study involving human subjects diagnosed with Congenital Heart Defects/Disease (CHD). The Co-Op @ HeartWorks is a cooperative between the research platform at HeartWorks and members of the CHD…
- Trial name
- NCT06469918
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- HeartWorks, Inc.
Hypoplastic Left Heart Syndrome
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial.
The purpose of this study is to test whether Lomecel-B™ works in treating patients with hypoplastic left heart syndrome (HLHS) and to gather additional information about the safety of Lomecel-B.
- Trial name
- ELPIS II (NCT04925024)
- Testing
- Lomecel-B medicinal signaling cells
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Longeveron Inc.
Hypoplastic Left Heart Syndrome
A Prospective Study of Patients With Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation
Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that consists of multiple obstructions to flow through the left heart and aorta, as well as hypoplasia of the left ventricle.
- Trial name
- NCT01708863
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Timothy J Nelson, MD, PhD
Hypoplastic Left Heart Syndrome
Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome
This is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children undergoing a scheduled Glenn…
- Trial name
- NCT01883076
- Testing
- autologous cell-based delivery
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Timothy J Nelson, MD, PhD
Hypoplastic Left Heart Syndrome (HLHS), Aortic Arch Hypoplasia
Seeking for Perfected Aortic Arch Reconstruction Using a Graphically Designed Patient-specific Surgical Patch
Vascular Reconstruction is one of the most challenging areas of surgery, the surgeon has to create a completely watertight reconstruction without any narrowing or deformity that will restore normal flow characteristics, even at…
- Trial name
- NCT06853054
- Testing
- Personalized patch template
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- The Hospital for Sick Children
Hypoplastic Left Heart Syndrome
Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome
This study is intended to evaluate the safety and feasibility of intramyocardial injection of allogeneic mesenchymal cells during the Bi-Directional Cavopulmonary Anastomosis (BDCPA) surgery for hypoplastic left heart syndrome…
- Trial name
- ELPIS (NCT02398604)
- Testing
- Allo-hMSCs
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Longeveron Inc.
Hypoplastic Left Heart Syndrome (HLHS)
National Collaborative to Improve Care of Children With Complex Congenital Heart Disease
The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between…
- Trial name
- NPC-QIC (NCT02852031)
- Testing
- Collaborative Learning Network
- Where
- 63 sites in United States, Canada and 1 more
- Volunteers
- 1,000 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology.
- Trial name
- NCT07884318
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Hypoplastic Left Heart Syndrome
Safety and Feasibility Study of Umbilical Cord Blood Cells for Infants With Hypoplastic Left Heart Syndrome
Further study details as provided by Duke University: Purpose: To evaluate the feasibility and safety of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome…
- Trial name
- NCT01445041
- Testing
- Autologous Umbilical Cord Blood
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Michael Cotten
Hypoplastic Left Heart Syndrome (HLHS)
Umbilical Cord Blood Collection and Processing for Hypoplastic Left Heart Syndrome Patients
Cell-based cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with severe structural abnormalities may also be reasonable targets for cell-based therapies.
- Trial name
- NCT01856049
- Testing
- Collection of umbilical cord blood
- Where
- 2 sites in United States
- Volunteers
- 464 people
- Sponsor
- Mayo Clinic