PRESS RELEASE: Successfully Seeding a Broken Heart – Heartseed Inc. succeeds in first human dosing of cardiomyocyte spheroids derived from allogeneic iPS Cells in PhⅠ/Ⅱ clinical trial for advanced heart failure utilizing iMatrix™ family of products.

Heartseed Inc, announced that Heartseed successfully dosed the first patient with HS-001, an investigational iPS cell derived therapy for heart failure, in a phase 1/2 clinical study (LAPiS Study). An independent safety review committee has given approval for the study to continue, and a total 10 patients suffering from ischemic heart disease will be enrolled at various sites in Japan.

According to the American Heart Association, heart failure affects an estimated 64.3 million people worldwide, and the number is expected to rise due to aging populations, lifestyle factors, and other health conditions such as diabetes and hypertension. Advanced heart failure is a condition in which the heart is no longer able to pump blood effectively to meet the body’s needs. This can occur as a result of various underlying heart diseases or conditions, such as coronary artery disease, heart valve disease, cardiomyopathy, or congenital heart defects.

HS-001 is an investigational cell therapy consisting of clusters of purified heart muscle cells (cardiomyocyte spheroids) derived from induced pluripotent stem cells (iPSCs) that are designed to restore heart muscle and function in patients with advanced heart failure. The small clusters of heart cells make it more difficult to be pumped out by the heart versus single cells.

Heartseed has been using the Matrixome’s iMatrix™ family of products for their research and clinical study. iMatrix™ is a technology based on laminin E8 fragments. As part of the extracellular matrix (ECM), laminin plays an important role in stem cell generation as well as supporting different tissue types. Products such as iMatrix-511 and iMatrix-221 (both available in research and clinical grades) can be used for the generation of stem cells and cardiomyocytes respectively.  

To find out more about the clinical study, please read the Heartseed Press Release: