Clinical trials: Hypoplastic Left Heart Syndrome
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.
Transfusional Iron Overload, Transfusional Hemosiderosis
Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions. The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a…
- Trial name
- CORDELIA (NCT00600938)
- Testing
- Core Study: Deferasirox, Core Study: Deferoxamine, Extension: deferoxamine to deferasirox
- Where
- 21 sites in Canada, China and 9 more
- Volunteers
- 197 people
- Sponsor
- Novartis Pharmaceuticals
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
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
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.
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.