Lomecel-B for Hypoplastic Left Heart Syndrome
(ELPIS Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on anti-arrhythmia therapy, you may not be eligible to participate.
What data supports the effectiveness of the treatment Lomecel-B for Hypoplastic Left Heart Syndrome?
Research suggests that mesenchymal stem cells, like those in Lomecel-B, may help improve heart function in patients with Hypoplastic Left Heart Syndrome by delivering biological signals that support the heart's right ventricle. Studies in similar treatments have shown potential benefits in heart function, which is promising for this condition.12345
Is Lomecel-B safe for humans?
The ELPIS trial is testing the safety of Lomecel-B (mesenchymal stem cells) in children with hypoplastic left heart syndrome by monitoring for major heart-related issues. If no serious problems occur in the first 10 patients, the study will continue to further test its safety and effectiveness.23467
How is the treatment Lomecel-B different from other treatments for hypoplastic left heart syndrome?
Lomecel-B is unique because it is a regenerative medicine approach, which aims to repair or replace damaged heart tissue, potentially offering a curative option rather than just managing symptoms like traditional surgeries. This treatment may involve using stem cells or similar regenerative techniques to improve heart function, which is different from the standard surgical interventions currently used for hypoplastic left heart syndrome.14589
What is the purpose of this trial?
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
Eligibility Criteria
This trial is for patients with Hypoplastic Left Heart Syndrome (HLHS) who need stage II surgery. It's not for those with certain HLHS complications, positive tests for HIV/HBV/HCV, chromosomal abnormalities, arrhythmias needing treatment, or additional heart issues requiring other surgeries.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Stage I
10 HLHS patients in Cohort A receive Lomecel-B via intramyocardial injections during Stage II surgery. Initial 3 patients evaluated for 5 days for safety.
Safety Review
Formal safety review conducted 6 months post-treatment of the last patient in Cohort A.
Treatment - Stage II
20 HLHS patients randomized in a double-blind manner to receive Lomecel-B or no treatment during Stage II surgery.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cardiac function and somatic growth assessments.
Treatment Details
Interventions
- Lomecel-B
Find a Clinic Near You
Who Is Running the Clinical Trial?
Longeveron Inc.
Lead Sponsor