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Hypoplastic Left Heart Syndrome

7
Pipeline Programs
6
Companies
7
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
3
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Metcela
MetcelaJapan - Kanagawa
1 program
1
Autologous cardiac stem cellsPhase 31 trial
Active Trials
NCT02781922Recruiting40Est. Dec 2028
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
2 programs
1
1
AutologousPhase 2
autologous cell-based deliveryPhase 1
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
2 programs
1
1
AutologousPhase 21 trial
autologous cell-based deliveryPhase 11 trial
Active Trials
NCT01883076Completed30Est. Apr 2021
NCT03779711Active Not Recruiting95Est. Feb 2026
Innovation Pharmaceuticals
1 program
1
Cardiac progenitor cell infusionPhase 21 trial
Active Trials
NCT01829750Completed34Est. Sep 2016
Ventrix
VentrixCA - San Diego
1 program
1
Ventrix Bio Extracellular MatrixPhase 11 trial
Active Trials
NCT06461676Not Yet Recruiting12Est. Sep 2028
Longeveron
LongeveronMIAMI, FL
2 programs
Allo-hMSCsPHASE_11 trial
Lomecel-B medicinal signaling cellsPHASE_21 trial
Active Trials
NCT02398604Terminated5Est. Mar 2019
NCT04925024Active Not Recruiting40Est. Aug 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
MetcelaAutologous cardiac stem cells
LongeveronLomecel-B medicinal signaling cells
Colorado TherapeuticsAutologous
Innovation PharmaceuticalsCardiac progenitor cell infusion
VentrixVentrix Bio Extracellular Matrix
LongeveronAllo-hMSCs
Colorado Therapeuticsautologous cell-based delivery

Clinical Trials (7)

Total enrollment: 256 patients across 7 trials

NCT02781922MetcelaAutologous cardiac stem cells

Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)

Start: Jun 2016Est. completion: Dec 202840 patients
Phase 3Recruiting
NCT04925024LongeveronLomecel-B medicinal signaling cells

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

Start: Jun 2021Est. completion: Aug 202640 patients
Phase 2Active Not Recruiting
NCT03779711Colorado TherapeuticsAutologous

Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome

Start: Jun 2019Est. completion: Feb 202695 patients
Phase 2Active Not Recruiting
NCT01829750Innovation PharmaceuticalsCardiac progenitor cell infusion

Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)

Start: Apr 2013Est. completion: Sep 201634 patients
Phase 2Completed
NCT06461676VentrixVentrix Bio Extracellular Matrix

Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients with Hypoplastic Left Heart Syndrome (HLHS)

Start: Aug 2025Est. completion: Sep 202812 patients
Phase 1Not Yet Recruiting
NCT02398604LongeveronAllo-hMSCs

Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome

Start: Apr 2015Est. completion: Mar 20195 patients
Phase 1Terminated
NCT01883076Colorado Therapeuticsautologous cell-based delivery

Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome

Start: May 2013Est. completion: Apr 202130 patients
Phase 1Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 256 patients
6 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.