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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 25, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

August 31, 2026

Conditions
Hypoplastic Left Heart Syndrome
Interventions
BIOLOGICAL

Lomecel-B medicinal signaling cells

A single administration of Lomecel-B will be performed via 6-10 intramyocardial injections into the right ventricle during the participant's standard of care stage II palliation. Dosing is based on body weight. Each patient will be given 2.5 x 10\^5 cells per kg of body weight. The entire dose of the cells will be roughly 600 microliters.

Trial Locations (10)

19104

Children's Hospital of Philadelphia, Philadelphia

30322

Children's Healthcare of Atlanta, Atlanta

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

60453

Advocate Children's Hospital, Chicago

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

68114

Children's Nebraska, Omaha

80045

Children's Hospital Colorado, Aurora

84113

Primary Children's Hospital/University of Utah, Salt Lake City

90027

Children's Hospital of Los Angeles, Los Angeles

02115

Boston Children's Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

collaborator

The University of Texas Health Science Center, Houston

OTHER

lead

Longeveron Inc.

INDUSTRY

NCT04925024 - Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. | Biotech Hunter | Biotech Hunter