NCT05068674

Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction

A Phase I, Randomized Pilot Study of Human Embryonic Stem Cell-Derived Cardiomyocytes (hESC-CMs) in PaTients With ChrOnic Ischemic Left VentRicular Dysfunction Secondary to Myocardial Infarction (HECTOR)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Joseph C. Wu · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will utilize a new cell therapy approach (Human embryonic stem cells derived cardiomyocytes or hESC-CMs) to improve survival and cardiac function in patients with chronic left ventricular dysfunction secondary to MI (Myocardial Infarction).

Detailed description

The phase I dose-escalation pilot study is intended as an initial safety assessment to establish the MTD prior to the phase II randomized, double-blinded, placebo-controlled study. An estimated eighteen (18) patients in phase I who are scheduled to undergo cardiac catheterization and have met all inclusion/exclusion criteria will be enrolled.

Conditions

• Chronic Ischemic Left Ventricular Dysfunction

Interventions

Type	Name	Description
DRUG	Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells	50 million (M) cells delivered in a dose of 5M cells per injection over 10 injections.
DRUG	Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells	150M cells delivered in a dose of 15M cells per injection over 10 injections
DRUG	Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells	300M cells delivered in a dose of 30M per injection over 10 injections

Timeline

• Start date: 2022-03-22
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2021-10-06
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study