BioCentury
ARTICLE | Politics & Policy

IOM addresses mitochondrial replacement therapy

February 4, 2016 2:05 AM UTC

The Institute of Medicine division of the National Academies of Sciences, Engineering and Medicine released a report Wednesday addressing ethical, social and policy considerations surrounding the clinical use of mitochondrial replacement therapy (MRT). The report, which FDA requested, endorsed clinical MRT when specific conditions are met, including limiting its use to life-threatening mitochondrial diseases.

The report said FDA should consider limiting its approval of clinical MRT trials to studies in women at risk of passing on diseases that are life-threatening to their offspring. It also recommended allowing only male embryos to be transferred to women in early studies to reduce the risk of heritable mutations, with possible expansion to female embryos after safety and efficacy are determined. ...