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NCT02398604 · ClinicalTrials.gov registry record · Phase 1
Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome
A Phase 1 study, sponsored by Longeveron.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02398604: Clinical Trial Phase 1 study, sponsored by Longeveron.
NCT02398604 is a Phase 1 study that was terminated before completion, run by Longeveron. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02398604, a Phase 1 study, was terminated before completion, sponsored by Longeveron.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
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 (HLHS) pediatric patients.
Primary Outcome
Monitoring of events includes death, sustained/symptomatic ventricular tachycardia requiring intervention with inotropic support, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.
Interventions
- DRUG Placebo
- DRUG Allo-hMSCs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-03 |
| Phase | Phase 1 |
Why NCT02398604 stopped before completion
NCT02398604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02398604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02398604 about?
NCT02398604 is a clinical study titled "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 (HLHS) pediatric patients.
What is the current status of trial NCT02398604?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2015-04. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02398604?
The interventions under investigation include: Placebo (DRUG), Allo-hMSCs (DRUG).
Who is sponsoring clinical trial NCT02398604?
This trial is sponsored by Longeveron, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02398604's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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