Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy

Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy - Clinical trial of human (allogeneic) iPS cell-derived cardiomyocyte sheet for severe cardiomyopathy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032989

Enrollment

Registered

2018-06-15

Start date

2019-08-11

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

Ischemic cardiomyopathy

Interventions

Human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Ischemic cardiomyopathy 2)NYHA Class III,IV 3)Patients who can not expect symptomatic improvement with standard treatment for target disease. To be recognized by the third party committee with experts 4)Ejection fraction<=35%

Exclusion criteria

Exclusion criteria: 1)Severe infection. 2)Alcoholic or drug addiction in recent six months 3)Malignancy 4)Virus infection(HIV,HBV,HCV,HTLV) 5)Pregnancy 6)Hypersensitivity 7)Contraindication(Immunosuppressant) 8)Others

Design outcomes

Primary

Measure	Time frame
Feasibility and safety evaluation of human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation (presence / absence, type, severity, frequency of expression and duration of adverse event accompanying iPS cell derived-cardiomyocyte sheet transplantation)	—

Secondary

Measure	Time frame
Evaluation of LVEF, left ventricular remodeling, severity of symptoms of heart failure from protocol treatment to 1 year after protocol treatment	—

Countries

Japan

Contacts

Public ContactShigeru Miyagawa

Osaka University Graduate School of Medicine Cardiovascular surgery

miyagawakenkyu@surg1.med.osaka-u.ac.jp06-6879-3154

Outcome results

None listed

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