FDP-2B:The new generation of cgmp compliant lyophilized platelet rich plasma.

Abstract

Background & Aim Platelet Rich Plasma (PRP) is a fraction of peripheral blood by concentration of platelets that generates clinically useful levels of various growth factors such as platelet-derived growth factor (PDGF), fibroblast growth factors (FGF) and epithelial growth factor (EGF). However, due to intensive time and labour, it can be difficult to prepare an adequate and consistent amount of platelets. Thus, we have generated a new method of PRP which could be isolated before hand and stored for further use. Methods, Results & Conclusion Fresh PRP with 2 billion platelets/vial and freeze-dried PRP (FDP-2B) which were also stored in 2 billion platelets/vial has been prepared from peripheral blood of 8 healthy human volunteers (300 mL/person) ages 20-50 years old. Every vial of the fresh PRP from each donor were sent for growth factor studies right after the processing from the whole blood while the rest of the vials from each donor were freeze-dried and stored at three different temperatures of 4,-20 and -80°C. The growth factors (PDGF, FGF and EGF) concentration were examined after freezing and tested on day 10th, 1 month, 3 month, 6 month and 1 year post freeze drying. The successful samples processed for storage is 100%. All the three growth factors studied were present in both the fresh PRP(2B) and FDP-2B. However, it was observed that for every sample studied, the lyophilized PRP (FDP-2B) shows a significant increase (p