What is an “iPS cell-derived cardiomyocyte sheet”?

It is a processed sheet that can be transplanted into the heart as an allogenic cell medication that primarily consists of cardiomyocytes prepared from human iPS cells (iPS cardiomyocytes).
The target of this sheet is patients who have severe heart failure, but for whom there are no effective therapies other than heart transplant or VAD, and in whom it is expected that this treatment will have therapeutic effects of improving the cardiac functions and help the heart recover from heart failure.

History of the development of heart failure therapy using iPS cells by the group led by Professor Sawa, Osaka University

2000	Started myocardial regenerative therapy using cell sheets in collaboration with Tokyo Women’s Medical University
2006	Professor Shinya Yamanaka,Kyoto University,succeeded to establish iPScells.
2007	Started clinical research using myoblast sheets Professor Shinya Yamanaka, Kyoto University, succeeded to establish human iPS cells
2008	Started joint research with Kyoto University; human iPS cells were obtained from Kyoto University Succeeded with the induction of differentiation of human iPS cells to cardiomyocytes
2012	Confirmed the effectiveness in large animals (swine) Started a clinical trial using myoblast sheets for severe heart failure
2013	Selected as a “Center for Clinical Application Research on a Specific Disease/Organ (Type A)” under the AMED Program “Research Center Network for Realization of Regenerative Medicine”
2015	Obtained clinical iPS cells from Kyoto University Started to consult PMDA concerning manufacturing methods and non-clinical safety studies (Terumo obtained PMDA marketing authrization for “HeartSheet”, skelental myoblast sheets in Japan)
2016	Established a master cell bank for clinical iPS cells
2017	Applied for a clinical research using iPS cells for severe heart failure
2018	Approved for initiation of the clinical research
2019	Submitted IND for an investigator-initiated clinical study using iPS cell derived cardiomyocyte sheet for the treatment of ischemic cardiomyopathy
2020	Initiated the clinical study for ischemic cardiomyopathy

Based on Osaka University’s slides
* AMED: Japan Agency for Medical Research and Development
PMDA: Pharmaceuticals and Medical Devices Agency

Our Strengths

Based on our joint research with Osaka University, we possess technological strengths in the following fields.

• Stable undifferentiated subculture of human iPS cells
• Induction of the differentiation of human iPS cells, and preparation of the differentiated cells (particularly cardiomyocytes)
• High-purity purification of human iPS cell-derived cardiomyocytes, and removal of undifferentiated cells
• Analysis of human iPS cells and differentiated cells, and characterization analysis

These strengths are indispensable in the development and commercialization of regenerative medicine products using iPS cell-derived cardiomyocytes. These are also useful as research tools for drug discovery leveraging iPS cells targeting not only cardiomyocytes, but also other organs.