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

JRCT ID: jRCT2033210163

Registered date:23/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure with ischemic heart disease
• Date of first enrollment: 23/06/2021
• Target sample size: 10
• Study type: Interventional

Intervention(s)

During CABG with median sternotomy, human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids are transplanted to anterior, lateral, posterior and inferior using spheroid transplantation needle.
Dose; 50 million or 150 million cells / body.
After transplantation, subject take Immunosuppressant (taclolims, MMF and steroid).

Outcome(s)

• Primary Outcome: Safety

Secondary Outcome

Heart function
QOL

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kaneko Takehiko