Using GMP iPS Cells from I Peace, Heartseed Succeeds in Stable Production of High Purity Cardiomyocytes, A Major Step Forward in Advancing Autologous Cardiac Regenerative Medicine

Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies based in Palo Alto, CA, and Heartseed Inc. (“Heartseed”), a Tokyo-based biotechnology company developing iPSC-derived cardiomyocytes for heart failure, have collaborated to generate cardiomyocytes using multiple donor-derived GMP grade iPS cell lines by I Peace, and Heartseed’s proprietary cardiomyocytes differentiation and purification methods. Heartseed has successfully produced high-purity cardiomyocytes consistently from all I Peace manufactured iPS cell lines used in this study. This achievement marks a significant step forward in the realization of autologous cardiac regenerative medicine with I Peace’s personal iPS cell banking service (My Peace), to manufacture and store iPS cells, and induce them into cardiomyocytes for use in autologous cell therapy.

Significance of stable production of high-purity cardiomyocytes derived from iPS cells
A major advantage of medical treatment using autologous iPS cells is that immunosuppressive agents are not necessary because no immune reaction occurs when cells are transplanted. However, the differentiation efficiency of iPS cells into target cells varies, and to efficiently produce cardiomyocytes from different donor-derived iPS cells, it is necessary to optimize the method of cardiomyocyte production for each iPS cell. This has been a hurdle to the realization of medical treatment using autologous iPS cells.

Background of the study
I Peace has developed a technology to simultaneously generate iPS cells from multiple donors for their personalized iPS cell banking service (My Peace) and has been able to produce numerous clinical-grade iPS cells affordably and reliably.

Heartseed is developing HS-001 (open chest administration) and HS-005 (catheter administration), which are microtissues of highly purified cardiomyocytes (cardiomyocyte spheroids) generated from allogeneic iPS cells and is accumulating know-how on the properties of cardiomyocytes and efficient methods of inducing cardiomyocyte differentiation.

In this context, I Peace and Heartseed have been investigating the production of high-purity cardiomyocytes using multiple donor-derived iPS cell lines produced by I Peace, using Heartseed’s original method of cardiomyocyte differentiation and purification.

When a conventional cardiomyocyte differentiation method was applied, low differentiation efficiency was observed in many iPS cell lines (Figure 1). On the other hand, by applying Heartseed’s original cardiomyocyte differentiation method, high differentiation efficiency into cardiomyocytes was observed from all eight iPS cell lines from four different donors (Figure 2). Furthermore, by applying Heartseed’s proprietary purification method “Metabolic Selection” to the obtained cardiomyocytes, nearly 99% purity was achieved in all eight lines, making them suitable for medical applications.

I Peace will continue to work together with Heartseed towards establishing regenerative medicine for heart failures using patients’ own iPS cells. I Peace will also collaborate with various institutions in other fields.

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