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Medicinal Signaling Cells

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

Phase 2
Recruiting
Led By Stu Berger, MD
Research Sponsored by Longeveron Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All participants must have HLHS (includes all types) requiring Stage II palliation (Glenn or Hemi-Fontan operation).
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months
Awards & highlights

ELPIS II Trial Summary

This trial is testing whether Lomecel-B can help repair the heart in patients with HLHS.

Who is the study for?
This trial is for patients with Hypoplastic Left Heart Syndrome (HLHS) who are scheduled for Stage II heart surgery. It's not suitable for those unwilling to follow the study plan, with pacemakers, needing additional heart surgeries at the time of Stage II operation, or infected with HIV/HBV/HCV. People allergic to DMSO can't join.Check my eligibility
What is being tested?
The trial tests Lomecel-B™, which contains human mesenchymal stem cells from bone marrow donors. These cells may transform into heart and other types of cells and could help treat HLHS by repairing heart tissue.See study design
What are the potential side effects?
Potential side effects might include reactions related to immune response as these are donor-derived stem cells. Specific side effects aren't listed but generally could involve discomfort at injection site or fever.

ELPIS II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have HLHS and need a Stage II heart surgery.

ELPIS II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Change in PedsQL™ Infant Scales
Change in RV compliance/diastolic function
+17 more

ELPIS II Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lomecel B GroupExperimental Treatment1 Intervention
Participants randomized to receive Lomecel-B injections during their Stage II palliation.
Group II: No Study Intervention Control GroupActive Control1 Intervention
Participants randomized to receive no study intervention during their Stage II palliation.

Find a Location

Who is running the clinical trial?

Longeveron Inc.Lead Sponsor
9 Previous Clinical Trials
445 Total Patients Enrolled
2 Trials studying Hypoplastic Left Heart Syndrome
15 Patients Enrolled for Hypoplastic Left Heart Syndrome
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
253 Previous Clinical Trials
5,187,690 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,399 Total Patients Enrolled
5 Trials studying Hypoplastic Left Heart Syndrome
969 Patients Enrolled for Hypoplastic Left Heart Syndrome

Media Library

Lomecel-B (Medicinal Signaling Cells) Clinical Trial Eligibility Overview. Trial Name: NCT04925024 — Phase 2
Hypoplastic Left Heart Syndrome Research Study Groups: Lomecel B Group, No Study Intervention Control Group
Hypoplastic Left Heart Syndrome Clinical Trial 2023: Lomecel-B Highlights & Side Effects. Trial Name: NCT04925024 — Phase 2
Lomecel-B (Medicinal Signaling Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04925024 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What hazards may be associated with using Lomecel-B medicinal signaling cells?

"The safety of Lomecel-B medicinal signaling cells was assessed as a 2 due to the Phase 2 trial status, meaning there is no evidence supporting efficacy but some data confirming its security."

Answered by AI

How many participants are signing up for the experiment?

"To initiate this trial, 38 volunteers who meet the pre-determined criteria must sign up. Locations participating in these trials include Primary Children's Hospital/University of Utah and Cincinnati Children's Hospital Medical Center."

Answered by AI

In what geographic areas is this research endeavor being conducted?

"This clinical trial is presently in progress at 7 research centres. These sites are located across Salt Lake City, Cincinnati, Chicago and other municipalities. It is recommended that individuals choose the closest location to them if they decide to partake as it will reduce their commuting burden."

Answered by AI

Are there opportunities for volunteers to participate in this experiment?

"According to information provided on clinicaltrials.gov, this trial is actively recruiting patients with an initial posting date of June 25th 2021 and a last update occurring August 10th 2022."

Answered by AI
~9 spots leftby Mar 2025