Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial.
Purpose
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.
Condition
- Hypoplastic Left Heart Syndrome
Eligibility
- Eligible Ages
- Under 12 Months
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
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. |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Longeveron Inc.