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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated through 1 year post-treatment.
Awards & highlights
ELPIS Trial 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.Check my eligibility
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.See study design
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.
ELPIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have HLHS and need BDCPA surgery.
ELPIS Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreELPIS 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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Longeveron Mesenchymal Stem Cells
2016
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Longeveron Inc.Lead Sponsor
9 Previous Clinical Trials
473 Total Patients Enrolled
2 Trials studying Hypoplastic Left Heart Syndrome
43 Patients Enrolled for Hypoplastic Left Heart Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has specific genetic changes.I have HLHS and need BDCPA surgery.I have large blood vessels in my heart's artery.I need a device to help my heart pump blood before my heart surgery.I am on medication for an irregular heartbeat.I have HLHS with a restrictive or intact atrial septum.I am having the Norwood procedure but do not have hypoplastic left heart syndrome.You have tested positive for HIV, hepatitis B, or hepatitis C in your blood.My guardian cannot follow the required treatment plan.I need surgery for a narrowed aorta or to fix my tricuspid valve.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort C - Phase 2 Control Group
- Group 2: Cohort A - Phase 1 (Open Label)
- Group 3: Cohort B - Phase 2 Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research study open to individuals over the age of sixty?
"The research team is currently seeking participants aged between one day and one year old for this medical trial."
Answered by AI
Is registration to participate in this experiment still ongoing?
"The information located on clinicaltrials.gov reveals that this specific medical trial is not presently enrolling patients, despite the fact it was initially posted back in February of 2018 and last updated at the end of April 2023. Happily, there are 12 other studies actively taking partakers right now."
Answered by AI
Could I potentially join in the experimental protocol for this research?
"This clinical trial calls for 10 participants with hypoplastic left heart syndrome aged between 1 day and one year to enroll."
Answered by AI
Are there multiple locations in this city that are executing the investigation?
"Currently, the trial is running in 5 different cities: Cincinnati, Baltimore and Salt Lake City plus 2 other metropolitan areas. To alleviate travel stressors, it's best to pick a clinical site that falls close by your home."
Answered by AI
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