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A. E. Partal; Protocol for Production of Autologous Serum Eyedrops by Blood Banks. Invest. Ophthalmol. Vis. Sci. 2009;50(13):913.
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To create a standardized protocol for production of autologous serum eyedrops (ASEs) by blood banks, which could be implemented nationwide, in order to provide this service to ophthalmologists' practices and ultimately benefit patients with ocular surface disease.
Despite mounting evidence of beneficial effects of ASEs in many ocular surface diseases, ASEs are not FDA approved for treatment in U.S.. Ophthalmologists have very limited access to ASEs as a treatment modality due to cost, technical and legal implications associated with manufacture of these products. Currently there is no standardized mode of production in United States, as institutions and physicians employ a different protocol depending on the availability of blood banking equipment and expertise. Variations in parameters of production result in wide differences in the concentration of growth factors present in ASEs making comparison of studies' results very difficult.Based on in vitro and clinical studies, production parameters such as clotting phase (time and temperature), centrifugal force (duration and g force), dilution (extent and diluent used), and storage (temperature and duration) were standardized for implementation by blood banks. A protocol for good manufacturing practice including informed patient consent, strict documentation of protocol and sterile technique, and strict quality control implementation was also generated.
A standardized protocol was created by University of Tennessee in collaboration with LifeBlood MidSouth Blood Bank for safe production, storage, and administration of ASEs to patients with ocular surface disease under the care and supervision of the treating ophthalmologist and university institutional review board.
Efforts should be made to institute a national standardized protocol for the production of ASEs that can be followed by blood banks, making this service not only uniform across the country, but also more available to ophthalmologists who want to offer this treatment in their practice.
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