NYSCF Calls For Faster FDA Review to Curb Stem Cell Tourism Citing Baby Born Using Mitochondrial Replacement Therapy
A report in The New Scientist presents claims that the first baby was born in Mexico by a New York based doctor using mitochondrial replacement therapy (MRT), a technique pioneered and advanced by scientists at The New York Stem Cell Foundation Research Institute and colleagues in the United States and in the United Kingdom. This technique is currently unapproved for any use in the US.
Susan L. Solomon, NYSCF CEO, and Dr. Dieter Egli, NYSCF Senior Research Fellow and NYSCF – Robertson Investigator, call for faster FDA review of mitochondrial replacement therapy and other stem cell based research to curb stem cell tourism and provide needed services and treatments for patients in the United States under full FDA oversight and approval.
This spring, the National Academies of Sciences, Engineering, and Medicine’s Institute of Medicine (IOM) released a report stating that MRT is ethical, as long as specific conditions and principles are met. Since then, there has been no further action by the FDA regarding MRT.
NYSCF has been at the forefront of bringing mitochondrial replacement therapy to the clinic and in 2011, published a seminal paper in Nature that showed mitochondrial replacement could be done successfully with human oocytes. Our scientists have been working since then to ensure this procedure would be safe and efficacious when brought to the clinic.