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

Who is this study for? Pediatric patients up to age 12 months with hypoplastic left heart syndrome
What treatments are being studied? Lomecel-B medicinal signaling cells
Status: Active_not_recruiting
Location: See all (10) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to test whether Lomecel-B™ works in treating patients with hypoplastic left heart syndrome (HLHS) and to gather additional information about the safety of Lomecel-B. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active ingredient. MSCs are special cells in the body that are able to change into other types of cells, such as heart, blood, and muscle cells. MSCs are found in various tissues of the body, such as the bone marrow, which is the spongy tissue inside of your bones. Lomecel-B uses MSCs from bone marrow of unrelated young healthy donors. These are called allogeneic, and do not require donor matching to the patient.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:

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

Locations
United States
California
Children's Hospital of Los Angeles
Los Angeles
Colorado
Children's Hospital Colorado
Aurora
Georgia
Children's Healthcare of Atlanta
Atlanta
Illinois
Advocate Children's Hospital
Chicago
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Massachusetts
Boston Children's Hospital
Boston
Nebraska
Children's Nebraska
Omaha
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Utah
Primary Children's Hospital/University of Utah
Salt Lake City
Time Frame
Start Date: 2021-06-25
Completion Date: 2026-08-31
Participants
Target number of participants: 40
Treatments
Experimental: Lomecel B Group
Participants randomized to receive Lomecel-B injections during their Stage II palliation.
No_intervention: No Study Intervention Control Group
Participants randomized to receive no study intervention during their Stage II palliation.
Sponsors
Collaborators: The University of Texas Health Science Center, Houston, Ann & Robert H Lurie Children's Hospital of Chicago, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Longeveron Inc.

This content was sourced from clinicaltrials.gov