Clinical trial
Lomecel-B Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase I/II Study (ELPIS)
Name
00-0000-05
Description
This study is designed to assess the safety, tolerability, and efficacy of Lomecel-B as an adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS. Lomecel-B will be delivered via intramyocardial injections
Trial arms
Trial start
2018-02-21
Estimated PCD
2024-06-30
Trial end
2025-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Longeveron Mesenchymal Stem Cells
Allogeneic bone marrow-derived mesenchymal stem cell
Arms:
Cohort A - Phase 1 (Open Label), Cohort B - Phase 2 Treatment Group
Other names:
LMSCs
Size
10
Primary endpoint
Safety: To evaluate the safety and feasibility of intramyocardial injection of LMSCs during the Stage II (BDCPA) operation for HLHS via incidence of Treatment-Emergent Serious Adverse Events.
Evaluated through 1 year post-treatment.
Eligibility criteria
Inclusion Criteria: all patients must have HLHS (all types) requiring BDCPA surgery.
Exclusion Criteria: all patients must not have any of the following.
1. Significant coronary artery sinusoids.
2. Requirement for mechanical circulatory support prior to BDCPA surgery.
3. Underlying evidence of arrhythmia requiring anti-arrhythmia therapy.
4. Need for concomitant surgery for aortic coarctation or tricuspid valve repair.
5. HLHS and restrictive or intact atrial septum.
6. Undergoing the Stage I (Norwood) procedure that does not have HLHS.
7. Serum positivity for: HIV; hepatitis B virus surface antigen (HBV BsAg); and/or viremic hepatitis C virus (HCV).
8. Parent/guardian that is unwilling or unable to comply with necessary follow-up.
9. Unsuitability for the study based on the Investigator's clinical opinion.
10. Documented chromosomal abnormalities
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 1: 10 patient safety run-in: all patients treated with LMSCs during Stage II surgery.\n\nPhase 2: 20 patients randomized 1:1 to receive either LMSCs or no cells (controls) during Stage II surgery.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Phase 1: no masking. Phase 2: HLHS patients which will be randomized to the treatment and control arms in a 1:1 ratio', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}
Updated at
2023-10-04
1 organization
1 product
1 indication
Organization
LongeveronIndication
Hypoplastic Left Heart Syndrome