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Medicinal Signaling Cells

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

Aurora, CO
Phase 2
Recruiting
Led By Sunjay Kaushal, MD, PhD
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
Must not have
Undergoing the Stage I (Norwood) procedure that does not have HLHS
Presence of a pacemaker, or anticipated placement of a pacemaker, at the time of the Stage II palliation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months
Awards & highlights
No Placebo-Only Group

Summary

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

See full description
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.

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 a Stage II heart surgery.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am having the Norwood procedure but do not have hypoplastic left heart syndrome.
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Select...
I have a pacemaker or will get one before my Stage II treatment.
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Select...
I need a device to help my heart pump blood right before my second heart surgery.
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Select...
I need surgery for heart valve repair or to fix narrowing of my aorta.
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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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Closest Location:Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL· 276 miles

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
274 Previous Clinical Trials
5,183,572 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,980 Previous Clinical Trials
47,866,168 Total Patients Enrolled
5 Trials studying Hypoplastic Left Heart Syndrome
971 Patients Enrolled for Hypoplastic Left Heart Syndrome
The University of Texas Health Science Center, HoustonOTHER
971 Previous Clinical Trials
355,454 Total Patients Enrolled
Sunjay Kaushal, MD, PhDPrincipal Investigator - Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H. Lurie Children's Hospital of Chicago
Johns Hopkins University School Of Medicine (Medical School)
Johns Hopkins University School Medicine (Residency)
Stu Berger, MDPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago

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
~2 spots leftby Jun 2025
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