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NCT04925024 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial.
A Phase 2 study of Hypoplastic Left Heart Syndrome, sponsored by Longeveron.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 10
- Study locations
NCT04925024: Active Phase 2 study of Hypoplastic Left Heart Syndrome, sponsored by Longeveron.
NCT04925024 is a Phase 2 study of Hypoplastic Left Heart Syndrome that is active but no longer recruiting, run by Longeveron. The registered enrollment target is 40 participants, below the 108-participant average among 3 other Hypoplastic Left Heart Syndrome trials with a reported enrollment target (63% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04925024, a Phase 2 study of Hypoplastic Left Heart Syndrome, is active but no longer recruiting, sponsored by Longeveron.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
Efficacy will be reported as change in right ventricular ejection fraction (RVEF) assessed as a percentage and will be measured via cardiac magnetic resonance (CMR) imaging.
Conditions Studied
Interventions
- BIOLOGICAL Lomecel-B medicinal signaling cells
Study Locations (10)
Illinois
- Advocate Children's Hospital - Chicago
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
California
- Children's Hospital of Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Georgia
- Children's Healthcare of Atlanta - Atlanta
Massachusetts
- Boston Children's Hospital - Boston
Nebraska
- Children's Nebraska - Omaha
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
What the registry record for NCT04925024 still lists
NCT04925024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 108-participant average among 3 other Hypoplastic Left Heart Syndrome trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Hypoplastic Left Heart Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Lomecel-B medicinal signaling cells is the first listed.
NCT04925024 lists 10 locations in 9 states (Illinois, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT04925024 about?
NCT04925024 is a clinical study titled "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. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active ingredient. MSCs are special cells i...
What is the current status of trial NCT04925024?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2021-06-25. Estimated completion is 2026-08-31.
What conditions does trial NCT04925024 study?
This clinical trial studies the following conditions: Hypoplastic Left Heart Syndrome.
What interventions are being tested in trial NCT04925024?
The interventions under investigation include: Lomecel-B medicinal signaling cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04925024?
This trial is sponsored by Longeveron, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04925024 being conducted?
This trial has 10 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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