Hope vs. caution: ethical and regulatory considerations for neonatal stem cell therapies

Abstract

T he Annual Review issue of Pediatric Research contains important reviews and original reports focusing on stem cell therapy for the treatment of neonatal lung disease (1), pediatric brain injury (2), congenital anomalies (3), and congenital heart disease (4). The authors describe the potential of these approaches to advance the care of children with life-threatening conditions and those with significant long-term chronic morbidities. The authors also describe the promise, ethical challenges, and limitations of these evolving therapeutic approaches. In considering these important advances, several themes are worthy of consideration, especially as related to potential cell-based therapies in neonates. These themes can be broadly categorized into study design, recruitment, funding and sponsorship, and ethical and regulatory complexities.