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Lomecel-B for Hypoplastic Left Heart Syndrome (ELPIS Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Longeveron Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients must have HLHS (all types) requiring BDCPA surgery.

Be younger than 18 years old

Must not have

Documented chromosomal abnormalities

Significant coronary artery sinusoids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated through 1 year post-treatment.

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates if a drug, Lomecel-B, is safe and effective to treat a rare heart defect when used alongside surgery.

Who is the study for?

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.

What is being tested?

The study evaluates the safety and potential benefits of Lomecel-B stem cells given as an extra treatment during standard stage II surgery for HLHS. The cells are injected directly into the heart muscle.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include reactions at injection sites, immune responses to the stem cells, or general surgical complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have HLHS and need BDCPA surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has specific genetic changes.

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I have large blood vessels in my heart's artery.

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I need a device to help my heart pump blood before my heart surgery.

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I have HLHS with a restrictive or intact atrial septum.

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I am having the Norwood procedure but do not have hypoplastic left heart syndrome.

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My guardian cannot follow the required treatment plan.

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I am on medication for an irregular heartbeat.

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I need surgery for a narrowed aorta or to fix my tricuspid valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated through 1 year post-treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated through 1 year post-treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated through 1 year post-treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety: To evaluate the safety and feasibility of intramyocardial injection of LMSCs during the Stage II (BDCPA) operation for HLHS via incidence of Treatment-Emergent Serious Adverse Events.

Secondary study objectives

Efficacy: Change from baseline in right ventricular ejection fraction (%).

Efficacy: Change from baseline in right ventricular end-diastolic diameter.

Efficacy: Change from baseline in right ventricular end-diastolic volume.

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort B - Phase 2 Treatment GroupExperimental Treatment1 Intervention

Double-blinded, in which 20 HLHS patients will be randomized to either receive treatment with Longeveron Mesenchymal Stem Cells (LMSCs) (Cohort B, 10 patients) performed via intramyocardial injections during the Stage II (BDCPA) surgery, or will receive no cells and no injection (Cohort C, 10 patients) during the Stage II (BDCPA) surgery. The second stage is to obtain preliminary safety and efficacy data the will enable and guide a subsequent larger Phase 2 trial.

Group II: Cohort A - Phase 1 (Open Label)Experimental Treatment1 Intervention

10 consecutive HLHS patients will be enrolled and treated with Longeveron Mesenchymal Stem Cells (LMSCs). A single administration of LMSCs will be performed via intramyocardial injections during the Stage II (BDCPA) surgery. Dosing is based on body weight. Each LMSC-treated patient will be given 2.5 x 105 LMSCs per kg of body weight. The entire dose of the cells will be roughly 600 microliters.

Group III: Cohort C - Phase 2 Control GroupActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Longeveron Mesenchymal Stem Cells

2016

Completed Phase 1

~40

0 / 9Eligibility criteria met