NYSCF Calls For Faster FDA Review to Curb Stem Cell Tourism Citing Baby Born Using Mitochondrial Replacement Therapy Performed in Mexico

NEW YORK–(BUSINESS WIRE)– 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, 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.

“The development and timely review of new, high quality treatments for
patients must be a top priority for the US. Without rigorous regulatory
review and oversight in the US, many families and patients in need turn
to clinics abroad where they undergo treatments that may not be subject
to appropriate oversight,” said Susan L. Solomon, CEO of the NYSCF
Research Institute. “Our regulatory system can only work if it is timely
and nimble enough to react to technological developments as they occur.
This is a fast moving field that requires the full partnership of the
FDA throughout the development of new treatments, technologies, and
cures. The current federal funding challenges are a major problem for
advancing all novel treatments in the US, not only mitochondrial
replacement therapy.”

“We can be optimistic about the fact that a mitochondrial replacement
technique first used in human cells by us will likely be effective with
FDA oversight,” said Dr. Dieter Egli, NYSCF Senior Research Fellow,
NYSCF – Robertson Investigator, and lead scientist in the development of
the mitochondrial replacement technique. “Doctor and patient had to go
elsewhere to perform a version of the groundbreaking treatment that was
pioneered at NYSCF in the US. This is compounded by current laws that
restrict federal funding and therefore the ability to broadly perform
research and novel treatments in the field of stem cells and
reproduction in the US.”

Patients will continue to seek experimental treatments and therapies in
the hope of cures. This stem cell tourism undermines the legitimate
scientific efforts around the globe to incrementally work towards proven
and safe treatments.

About The New York Stem Cell Foundation Research Institute

The New York Stem Cell Foundation (NYSCF) Research Institute is an
independent organization accelerating cures and better treatments for
patients through stem cell research. The NYSCF Research Institute
employs over 45 researchers in New York, and is an acknowledged world
leader in stem cell research and in developing pioneering stem cell
technologies, including the NYSCF Global Stem Cell Array^TM.
Additionally, NYSCF supports over 86 researchers at other leading
institutions worldwide through its Innovator Programs, including the
NYSCF – Druckenmiller Fellowships and the NYSCF – Robertson Investigator
Awards. NYSCF focuses on translational research in a model designed to
overcome the barriers that slow discovery and replace silos with
collaboration. For more information, visit www.nyscf.org

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