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Gorka Orive, Francisco Jose Muruzabal, Ander Pino, Eduardo Anitua; Biological stability of Plasma Rich in Growth Factors (PRGF-Endoret) eye drops after 3 months of storage. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3887.
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© ARVO (1962-2015); The Authors (2016-present)
PRGF-Endoret eye drops are used for the treatment of a wide range of ocular surface diseases. The objective of this study was to evaluate whether PRGF-Endoret eye drops maintain their characteristics and their biological activity after 3 months stored at - 20 degree Celsius.
Blood from ten healthy donors was collected, centrifuged and Plasma Rich in Growth Factors (PRGF-Endoret) was prepared avoiding the buffy coat. The volume obtained was aliquoted to be used fresh or after storage at - 20 degree Celsius for 15, 30 and 60 days. Osmolarity, vitamin A, fibronectin and several growth factors like PDGF-AB, VEGF, EGF and TGF-β1 were quantified on fresh samples and after storage for 15, 30 and 60 days at - 20 degree Celsius. The proliferative and migratory potential of PRGF-Endoret eye drops after different storage conditions were assayed on primary human keratocytes. The sterility of each PRGF-Endoret sample stored for different time points was also analyzed.
Several morphogens including PDGF-AB, VEGF, EGF and also Vitamin A showed no significant variations along the study period. On the other hand, Fibronectin and TGF-β1 concentration showed significant reduction among fresh and freezing storage samples. Osmolarity of samples stored at - 20 degree Celsius increased significantly with regard to fresh samples, although the osmolarity values of samples stored at -20 degree Celsius was within osmolar range tolerated by the cornea. No differences were observed on proliferation and migration of keratocytes at any time of the study using the different PRGF-Endoret samples. Sterility analysis performed on each eye drops samples stored at different times showed no microbiological contamination.
Biological activity of the PRGF-Endoret eye drops is preserved after storage under freezing conditions for 3 months. All factors excluding TGF-β1 and fibronectin were maintained constant. Assuming this, we conclude that PRGF-Endorert eye drops maintain their biological stability for at least 3 months.
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