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

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 - LAPiS Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2033210163

Enrollment

Registered

2021-06-23

Start date

2021-06-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

During CABG with median sternotomy, human induced Pluripotent Stem (iPS) cell-derived cardiomyocyte spheroids are transplanted to anterior, lateral, posterior and inferior using spheroid transplantati

50 million or 150 million cells / body. After transplantation, subject take Immunosuppressant (taclolims, MMF and steroid).

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Heart function QOL	—

Contacts

Public ContactToiawase madoguchi

Heartseed Inc.

chiken@heartseed.jp+81-3-6380-1068

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026