Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Ischemic Heart Failure

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 75
Healthy Volunteers: f
View:

• 35-75 years of age (including 35 and 75 years)

• Willingness and ability to give written informed consent

• Patients with severe chronic ischemic heart failure

• New York Heart Association (NYHA) Class III or IV under optimal medical therapy

• Weakening or absence of segmental regional wall motion as determined by standard imaging.

• LVEF≤40% as assessed by MRI

• Nuclide-myocardial metabolic perfusion imaging revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area

• Patients have indications for Coronary Artery Bypass Grafting

Locations
Other Locations
China
TEDA International Cardiovascular Hospital
RECRUITING
Tianjin
Contact Information
Primary
Xiaocheng Liu
liuxc@tedaich.com
+86-022-65208030
Time Frame
Start Date: 2023-09-05
Estimated Completion Date: 2025-03-05
Participants
Target number of participants: 36
Treatments
Experimental: HiCM-188 Low dose therapy
Intramyocardial injection of HiCM-188 (50 million) during CABG surgery.
Experimental: HiCM-188 Medium dose therapy
Intramyocardial injection of HiCM-188 (150 million) during CABG surgery. Interventions
Experimental: HiCM-188 High dose therapy
Intramyocardial injection of HiCM-188 (450 million) during CABG surgery. Interventions
Related Therapeutic Areas
Sponsors
Collaborators: TEDA International Cardiovascular Hospital
Leads: Help Therapeutics

This content was sourced from clinicaltrials.gov

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