All Posts tagged Replacement Therapy

Bilateral Retinal Detachments After Intravitreal Injection of Adipose-Derived ‘Stem Cells’ in a Patient With Exudative Macular Degeneration

Abstract

A 77-year-old woman with exudative macular degeneration underwent bilateral intravitreal injections of “stem cells” at a clinic in Georgia. One month and 3 months after injection, she developed retinal detachments in the left and right eyes, respectively. Increased awareness within the medical community of such poor outcomes is critical so that clinics offering untested practices that have been shown to be potentially harmful to patients can be identified and brought under U.S. Food and Drug Administration oversight.

Introduction

Enthusiasm for stem cell treatment has given rise to numerous clinics in the United States offering unproven “stem cell” therapies without the oversight of the U.S. Food and Drug Administration (FDA). Though current FDA-regulated clinical trials are ongoing to evaluate the use of stem cell technology, unproven and unregulated “stem cell” therapies are already being offered to patients in hundreds of clinics in the United States. In June 2016, the American Academy of Ophthalmology published a clinical statement warning that unproven “stem cell” therapies “require further scientific evaluation to assure their safety and effectiveness to the public in well-conducted clinical trials under the aegis of the FDA.”1 Here, we describe a case of delayed retinal detachment with poor visual acuity and anatomical outcomes following bilateral intravitreal injection of autologous adipose tissue-derived “stem cell” therapy in a clinic in Georgia performed without FDA oversight.

Full Paper: Bilateral Retinal Detachments After Intravitreal Injection of Adipose-Derived ‘Stem Cells’ in a Patient With Exudative Macular Degeneration
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Acknowledged by the Foundation for Fighting Blindness

We were acknowledged by the Foundation for Fighting Blindness for our effort in one of six emerging retinal therapies receiving foundation funding as part of its Translational Research Acceleration Program (TRAP). The emerging treatments included those using stem cells, gene therapies, and pharmaceuticals.

Multilayered Cell Replacement Therapy

Many retinal diseases, including Stargardt disease, dry age-related macular degeneration, and choroideremia, lead to loss of photoreceptors and a supportive layer of cells called retina pigment epithelium (RPE). Dr. David Gamm of the University of Wisconsin is using induced pluripotent stem cells (iPSC) to develop a two-layered cell replacement therapy.

To minimize rejection of this and other treatments, he is also developing lines of iPSC from “super donors,” individuals from across the United States whose immune profiles favorably math those of the country’s general population. For these efforts, Dr. Gamm is collaborating with scientists from: University of California, Santa Barbara; University of Pennsylvania; Cellular Dynamics International; and Retina Vitreous Resource Center in Louisville, Kentucky.

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