Clinical Trials Logo
  1. Home
  2. Hypoplastic Left Heart Syndrome
  3. NCT04925024

Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. — ELPIS II  

Hypoplastic Left Heart Syndrome Clinical Trial

Official title:
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS) : A Phase IIb Clinical Trial.

Clinical Trial Summary

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. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active ingredient. MSCs are special cells in the body that are able to change into other types of cells, such as heart, blood, and muscle cells. MSCs are found in various tissues of the body, such as the bone marrow, which is the spongy tissue inside of your bones. Lomecel-B uses MSCs from bone marrow of unrelated young healthy donors. These are called "allogeneic", and do not require donor matching to the patient.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04925024
Study type Interventional
Source Longeveron Inc.
Contact Stephanie Brazis, MPH
Phone 312-227-0201
Email sbrazis@luriechildrens.org
Status Recruiting
Phase Phase 2
Start date June 25, 2021
Completion date August 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT01215240 - Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure N/A
Completed NCT00513240 - Erythropoetin Neuroprotection for Neonatal Cardiac Surgery Phase 1/Phase 2
Withdrawn NCT00156455 - Sleep Disordered Breathing in Children With Single Ventricle Physiology N/A
Terminated NCT01445041 - Safety and Feasibility Study of Umbilical Cord Blood Cells for Infants With Hypoplastic Left Heart Syndrome Phase 1
Recruiting NCT04581668 - Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease N/A
Completed NCT01708863 - A Prospective Study of Patients With Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation
Completed NCT01736956 - Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome N/A
Recruiting NCT03406884 - The CHILD Trial: Hypoplastic Left Heart Syndrome Study. Phase 1
Not yet recruiting 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
Active, not recruiting NCT03079401 - Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle Phase 1/Phase 2
Completed NCT02306057 - Fluid Balance in Children Undergoing Fontan Surgery N/A
Terminated NCT01107990 - Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
Completed NCT01883076 - Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome Phase 1
Completed NCT04056416 - Physical Activity Promotion in Children and Adolescents With Single Ventricle Physiology (MedBike) N/A
Completed NCT01656941 - Genetic Determinants of Congenital Heart Disease Outcomes
Completed NCT00464100 - Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes
Active, not recruiting NCT03779711 - Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome Phase 2
Recruiting NCT02781922 - Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial) Phase 3
Completed NCT01582529 - SVRII Family Factors Study
Completed NCT00974025 - Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients N/A