Elpiscience Regenerative Medicine Receives FDA IND Approval for Its Novel iPSC-Derived Cardiomyocyte Therapy HiCM-188 in Heart Failure

Recently, Help Stem Cell Innovations Co., Ltd. (hereinafter referred to as “Help Stem Cell Innovations”) has achieved another milestone in the independent development of its next-generation cell therapy, “Human iPSC-Derived Cardiomyocyte Injection” (HiCM-188). The project has officially received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). It is the first iPSC-derived innovative cell therapy approved for clinical evaluation in the treatment of end-stage heart failure in the United States, and the first heart failure cell therapy product globally to obtain IND registration in both China and the United States. This achievement fully demonstrates Help Stem Cell Innovations’ exceptional drug development capabilities and represents a successful implementation of the company’s strategy centered on source innovation, high-quality standards, and global expansion.

An aging society poses numerous challenges to healthcare, with heart failure being one of them. Currently, there are over 65 million patients with heart failure worldwide, and this number continues to increase by more than 500,000 annually. Common treatments for heart failure include medical therapy, surgical intervention, heart transplantation, and artificial hearts; however, the clinical efficacy of these approaches is often suboptimal, failing to effectively improve patients’ quality of life. “HiCM-188,” an injection of human induced pluripotent stem cell (iPSC)-derived cardiomyocytes, is an innovative “off-the-shelf” cell therapy independently developed by Help Stem Cell Innovations Co., Ltd. for the treatment of severe chronic ischemic heart failure. It has previously received approval in China to conduct clinical trials, demonstrating safety and preliminary efficacy results, thereby offering a new therapeutic option for patients with heart failure.

Following the IND approval in the United States, a Phase I clinical trial will be conducted, with the primary objective of evaluating the safety and tolerability of the product one year post-transplantation at various dose levels. The study is expected to enroll participants across multiple research centers in the United States.

One of the planned trial centers —Professor Emerson C. Perin, Medical Director of the Texas Heart Institutestated, “I am confident that Help Stem Cell Innovations Co., Ltd. will drive the advancement of the cell therapy field; this milestone represents a significant step in its R&D projects. I look forward to collaborating with them on this clinical program.”

Academician of the Chinese Academy of Sciences, Professor Ge Junbo, Director of the Department of Cardiology at Zhongshan Hospital, Fudan Universitystated: “Help Stem Cell Innovations’ independently developed innovative drug is the first Investigational New Drug (IND) application approved by the U.S. Food and Drug Administration that utilizes iPSC technology for cardiovascular indications. This is an exciting and proud achievement, representing a significant milestone for China’s innovative cardiovascular drugs and ushering in a new chapter for cell therapy innovation in China.”

Professor Philippe Menasché of Paris Descartes University“The transplantation of cardiomyocyte tissue derived from pluripotent stem cells increases the number of contractile cells in the heart, improves cardiac function, and serves as an effective treatment for heart failure. The IND approval granted to Help Stem Cell Innovations represents a significant milestone in the field of cardiac regeneration, as it paves the way for the first large-scale efficacy trial. The results of this trial have the potential to validate the theoretical basis for cardiac remuscularization using cardiomyocyte-directed cells, thereby expanding the clinical indications for this innovative therapy.”

Dr. Wang Jiaxian, Founder and CEO of Help Stem Cell Innovations“The intensifying aging of the population has made heart failure an increasingly prominent issue. Due to the scarcity of donors for heart transplantation and the prohibitively high economic barriers associated with artificial heart technology, the clinical needs of a large number of heart failure patients remain unmet. Our independently developed innovative cell therapy—Regenerative Cardiomyocyte Injection (iPS-CMs: HiCM188)—has successfully received Investigational New Drug (IND) approval for clinical trials in the United States, filling a critical gap in this field. By transplanting fresh myocardial tissue into damaged areas, this product innovatively shifts the paradigm from whole-heart transplantation to precise myocardial repair, holding the promise of delivering a revolutionary treatment option for heart failure patients. Meanwhile, the company remains committed to developing affordable innovative medicines, aiming to create a cell therapy product that is accessible to patients and delivers broad benefits.”