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Clinical Trial Summary

The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure.

Clinical Trial Description

This is a single center, open-label, three-group dose-escalation (phase I) study followed by dose-extension (phase IIa) study in up to 36 severe ischemic heart failure patients. It is estimated that up to 18 phase I patients will be received HiCM-188 intramyocardial injection during CABG surgery. The maximum number of subjects after dose escalation and dose extension studies in each dose group is 12. All the subjects need take immunosuppressant after transplantation. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT06340048
Study type Interventional
Source Help Therapeutics
Contact Xiaocheng Liu
Phone +86-022-65208030
Status Recruiting
Phase Phase 1/Phase 2
Start date September 5, 2023
Completion date March 5, 2025

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