Abstract
Purpose:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
Keywords: 543 growth factors/growth factor receptors •
483 cornea: storage •
765 wound healing