Endocardial delivery of stem-cell derived heart cells to help severe heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase 1/2 trial enrolling adults with ischemic heart disease or dilated cardiomyopathy and reduced ejection fraction. After screening, participants receive transplantation of HS-001 CS via endocardial delivery and then take immunosuppressants while researchers monitor safety and heart function for 26 weeks. The study aims to determine safety and preliminary efficacy in a small cohort of 14 patients, with assessments of cardiac performance and adverse events. Primary goals focus on safety signals and feasibility of delivering iPSC-derived cardiomyocyte spheroids to the failing heart. No control group is described in the available information.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on screening echocardiographic assessment
* New York Heart Association (NYHA) cardiac function classification of grade II or III at screening
* Other Criteria apply, please contact the investigator

Exclusion Criteria:

* Patients with cardiac devices such as pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac resuscitation-enabled implantable cardioverter defibrillators (CRT-Ds)
* Patients with heart failure due to the primary disease hypertrophic cardiomyopathy (including the dilated phase), restrictive cardiomyopathy, amyloidosis, takotsubo cardiomyopathy, congenital heart disease, cardiac sarcoidosis, or constrictive pericarditis
* Other Criteria apply, please contact the investigator

Where it's running

• University of Tsukuba Hospital
  Tsukuba, Ibaraki, Japan Recruiting
• St. Marianna University Hospital
  Kawasaki, Kanagawa, Japan Recruiting
• Shinshu University Hospital
  Matsumoto, Nagano, Japan Recruiting
• Showa Medical University
  Shinagawa-Ku, Tokyo, Japan Recruiting
• Tokyo Medical University Hospital
  Shinjuku-ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Heartseed Inc.
• Email: contact@heartseed.jp
• Phone: +8163801068

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.