A phase I/II study of human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids in patients with severe heart failure, secondary to ischemic heart disease, undergoing coronary artery bypass grafting

Phase 1

Recruiting

• Conditions: Heart failure with ischemic heart disease; Ischemic heart disease, Heart Failure, Coronary artery bypass grafting (CABG)

• Registration Number: JPRN-jRCT2033210163
• Lead Sponsor: Kaneko Takehiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients with ischemic heart disease undergoing CABG
Patients with resting left ventricular ejection fraction (from 0.15 to 0.40) based on institutional assessment on either screening cardiac MRI or echocardiographic assessment
New York Heart Association Class II, III or IV

Exclusion Criteria

Patients who are candidates for cardiovascular surgery other than CABG (such as valvular heart surgery)
Patients with the following complications
Pulmonary hypertension, hypertension, diabetes, liver dysfunction, liver dysfunction, gait disturbance, active infection, active bleeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Heart function<br>QO