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

Sponsored by Longeveron Inc. (industry) · LGVN — their whole pipeline →. With National Heart, Lung, and Blood Institute (NHLBI), Ann & Robert H Lurie Children's Hospital of Chicago, The University of Texas Health Science Center, Houston.

Phase

Phase 2

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Triple · Treatment

Enrollment

40actual

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-06-25

actual

When the study began enrolling

Primary completion

2026-06-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-08-31

estimated

The whole study's end, after follow-up

First posted

2021-06-14

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2025-06-25

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Hypoplastic Left Heart Syndrome

Intervention

Biological: Lomecel-B medicinal signaling cells

Primary outcome

what the primary-completion date above is the date OF

Change in right ventricular ejection fraction (RVEF)

measured Baseline, 12 Months

Publications

PMID 36950450 — cited as background

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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