China published the first randomized controlled trial of iPSC-derived cardiomyocyte injection for severe heart failure in Nature Medicine (August 2026). Of 10 treated patients, 9 showed functional improvement at 12 months. Key limitations: small sample size (20 total), control group received bypass surgery without cell injection (confounding factor), allogeneic cells required immunosuppression, and primary endpoints focused on safety (no arrhythmia/tumors) rather than efficacy. Off-the-shelf cell production model offers cost/availability advantages but masks contribution of surgery alone.