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Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy

Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2053190081
Enrollment
10
Registered
2019-12-11
Start date
2020-01-10
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

Sponsors

Miyagawa Shigeru
Lead Sponsor

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) Autoimmune disease 2) Allergic or hypersensitive to the immunosuppressant 3) Severe infection 4) Persistent shock due to worsening heart failure 5) Irreversible organ failure other than heart 6) Maignancy 7) Pregnancy 8) Alcoholic or drug addiction in recent six months 9) Allergies or hypersensitivity to animals from which raw materials used 10) Severe pulmonary hypertension

Design outcomes

Primary

MeasureTime frame
Number of patients with improved LVEF compared with preoperative at 26 weeks after transplantation

Secondary

MeasureTime frame
1) Number of responders at 26 and 52 weeks after transplantation 2) Evaluation of the following changes before 26 and 52 weeks after transplantation (1) LVEF (2) Left ventricular remodeling (3) Severity of heart failure (4) Rejections (5) Others

Contacts

Public ContactTakuji Kawamura

Osaka university hospital

saisentan@tissue.med.osaka-u.ac.jp+81-6-6879-3154

Outcome results

None listed

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