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

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Longeveron Inc.

Stay on Your Current Meds

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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

I have HLHS and need BDCPA surgery.

Exclusion Criteria

My cancer has specific genetic changes.

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

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

+7 more

Participant Groups

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.

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