By Fineline Cube 
Nanjing-based HELP Therapeutics Co. Ltd, a clinical-stage cell therapy company, announced that its innovative induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy for heart failure has officially entered clinical trials in the U.S. This milestone marks the first iPSC-based cell therapy for end-stage heart failure to undergo clinical evaluation in the U.S. and the world’s first heart failure cell therapy to secure clinical trial approvals in both China and the U.S.
Regulatory Approvals and Global Evaluation
The company’s human iPSC-derived regenerative cardiomyocyte therapy, targeting moderate-to-severe heart failure, has received Investigational New Drug (IND) clearance in both China and the U.S., along with clinical study filing approval from China’s National Health Commission.
Proprietary Technology and Production Platform
HELP Therapeutics leverages its proprietary cell culture solution technology to enhance differentiation efficiency while reducing upstream production costs. Combined with its Help Cell-foundry mass production platform, the company aims to deliver a safe, effective, quality-controlled, and patient-accessible innovative therapy.
Addressing Global Medical Needs
By advancing this therapy, HELP Therapeutics aims to address the significant unmet global medical need for effective heart failure treatments, offering a novel approach to improving patient outcomes.-Fineline Info & Tech