Clinical trials: Hypoplastic Left Heart Syndrome (HLHS)
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.
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.
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.