March 21, 2017

American Academy of Ophthalmology Statement on Stem Cell Therapy for Treating Eye Disease

SAN FRANCISCO, March 20, 2017 /PRNewswire-HISPANIC PR WIRE/ -- A recent article in the New England Journal of Medicine highlights concerns that the American Academy of Ophthalmology has previously expressed regarding stem cell therapy for diseases of the retina. 

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In June 2016 the Academy issued clinical guidance that covers the appropriate use of stem cell therapy in eye care.  An article co-authored by the Academy's Chief Executive Officer in the November issue of the Academy's journal Ophthalmology highlights the dangers of unapproved trials, the need for appropriate oversight, and the risk to patients looking for a transformative cure. 

The Academy has called on both the National Institutes of Health and the U.S. Food and Drug Administration to take steps to better ensure public safety associated with treatments outside of FDA-approved clinical trials.  Good research is being performed under FDA-approved trials by innovative clinician-scientists and tragedy associated with non-approved use of stem cells threatens the conduct and impact of this high-quality science.

The public and patients can learn more about stem cells and eye care by visiting the Academy's EyeSmart® public education website. EyeSmart is the leading online source for ophthalmic information. The content is written and approved by Academy member eye physicians and surgeons.

About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public. We innovate to advance our profession and to ensure the delivery of the highest-quality eye care. Our EyeSmart® program provides the public with the most trusted information about eye health. For more information, visit aao.org.

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March 17, 2017

American Academy of Ophthalmology Statement on Stem Cell Therapy for Treating Eye Disease

SAN FRANCISCO, March 17, 2017 /PRNewswire-HISPANIC PR WIRE/ -- Statement attributable to:
David W. Parke, II, M.D.
CEO, American Academy of Ophthalmology

"The American Academy of Ophthalmology today reiterates its support of the Food and Drug Administration's regulations of stem cell therapy in the use of ophthalmic care.

"The blinding of three patients following stem cell injections from a clinic in Florida, as documented in a recent New England Journal of Medicine study, is tragic. While tantalizing for individuals desperately looking for a cure, research has yet to support the adoption of stem cell therapy treatment outside of clinical trials.

"These cases in Florida reaffirm our belief that emerging treatments, such as stem cell therapy, has not yielded sufficient proof. There must be a pause before proceeding, and care should be led by fully trained physicians.

"There is no substitute for scientific validation when patient safety is at risk."

The Academy has previously issued clinical guidance that covers the appropriate use of stem cell therapy in eye care. These recent cases confirm the Academy's belief that the FDA should thoroughly investigate and level regulatory action against unlicensed clinics who offer stem cell therapy treatments outside of clinical trials.

Public and patients can learn more about stem cells and eye care by visiting the Academy's EyeSmart® public education website. EyeSmart is the leading online source for ophthalmic information. The content is written and approved by Academy member eye physicians and surgeons.

About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public. We innovate to advance our profession and to ensure the delivery of the highest-quality eye care. Our EyeSmart® program provides the public with the most trusted information about eye health. For more information, visit aao.org.

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