First Autologous Stem Cell Heart Injection (2003)
French surgeon Philippe Menasché performed the first clinical injection of autologous skeletal myoblasts into human heart muscle using catheter-based delivery. Five patients with ischemic heart failure received cells via the MyoStar NOGA-guided catheter system. The procedure demonstrated feasibility but raised questions about arrhythmia risks.
The pilot study showed the approach was technically possible, with improvements in heart function observed at six-month follow-up.
This pioneering work launched two decades of clinical trials exploring catheter-based cell delivery to the heart, establishing transendocardial injection as a viable approach despite ongoing safety refinements.
BioCardia's Helix catheter represents the culmination of this 20+ year development arc—the first attempt to gain regulatory approval for a device category that has existed only in research settings.
