Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial.

• Register: ClinicalTrials.gov
• Last refreshed on: 24 February 2025
• Main ID: NCT04925024
• Date of registration: 08/06/2021
• Prospective Registration: Yes
• Primary sponsor: Longeveron Inc.
• Public title: Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. ELPIS II
• Scientific title: Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS) : A Phase IIb Clinical Trial.
• Date of first enrolment: June 25, 2021
• Target sample size: 38
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04925024
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Stephanie Brazis, MPH

• Name: Stu Berger, MD
• Affiliation: Ann & Robert H Lurie Children's Hospital of Chicago

Key inclusion & exclusion criteria

Inclusion:

All participants must have HLHS (includes all types) requiring Stage II palliation (Glenn
or Hemi-Fontan operation).

Exclusion:

1. Requirement for ongoing mechanical circulatory support immediately prior to Stage II
palliation within 5 days

2. Need for concomitant surgery for aortic coarctation or tricuspid valve repair or
Endocardial fibroelastosis (EFE) resection or left ventricle recruitment procedures

3. Undergoing the Stage I (Norwood) procedure that does not have HLHS

4. Serum positivity for: human immunodeficiency virus (HIV); hepatitis B virus surface
antigen (HBV BsAg); and/or viremic hepatitis C virus (HCV). This criterion can be
ascertained by one of three ways:

1. Documented history of mother's testing conducted during pregnancy

2. Documented history of participants testing.

3. If above documentation is not available blood will be obtained from participant
at Screening/Baseline.

5. Parent/guardian that is unwilling or unable to comply with necessary follow-up

6. Unsuitability for the study based on the Investigator's clinical opinion

7. Known hypersensitivity to dimethyl sulfoxide (DMSO)

8. Presence of a pacemaker, or anticipated placement of a pacemaker, at the time of the
Stage II palliation


Age minimum: N/A
Age maximum: 12 Months
Gender: All

Health Condition(s) or Problem(s) studied

Hypoplastic Left Heart Syndrome

Intervention(s)

Biological: Lomecel-B medicinal signaling cells

Primary Outcome(s)

Change in right ventricular ejection fraction (RVEF) [Time Frame: Baseline, 12 Months]

Secondary Outcome(s)

Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) [Time Frame: Baseline, 12 Months]

Change in RV compliance/diastolic function [Time Frame: Baseline, 12 Months]

Change in right ventricular end-diastolic volume index (RVEDVI) [Time Frame: Baseline, 12 Months]

Change in right ventricular end-systolic volume index (RVESVI) [Time Frame: Baseline, 12 Months]

Freedom from unplanned catheter intervention needed to address the pulmonary arteries or aorta. [Time Frame: Baseline, 12 Months]

Change in head circumference [Time Frame: Baseline, 12 Months]

Change in modified Ross Heart Failure Classification score [Time Frame: Baseline, 12 Months]

Change in right ventricular ejection fraction (RVEF) [Time Frame: Baseline, 6 Months]

Change in right ventricular global longitudinal strain and strain rate [Time Frame: Baseline, 12 Months]

Change in PedsQL™ Infant Scales [Time Frame: Baseline, 12 Months]

Change in right ventricular global circumferential strain and strain rate [Time Frame: Baseline, 12 Months]

Change in weight [Time Frame: Baseline, 12 Months]

Participants experiencing major adverse cardiac events (MACE) [Time Frame: Baseline, 12 Months]

Participants experiencing treatment emergent serious adverse events (TE-SAEs) [Time Frame: 30 days post Stage II palliation]

Change in length (height) [Time Frame: Baseline, 12 Months]

Change in tricuspid regurgitation severity [Time Frame: Baseline, 12 Months]

Change in biomarkers/cytokines [Time Frame: Baseline, 12 Months]

Change in right atrial volume index [Time Frame: Baseline, 12 Months]

Change in right ventricular mass index at diastole [Time Frame: Baseline, 12 Months]

Change in right ventricular work index [Time Frame: Baseline, 12 Months]

Secondary ID(s)

1U24HL148316-01A1

7UG3HL148318-02

2021-4531

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

The University of Texas Health Science Center, Houston

Ann & Robert H Lurie Children's Hospital of Chicago