Cerus Corporation, Concord, CA, USA, United States
Background/Case Studies: The INTERCEPT® Blood System for Platelets uses amotosalen and ultraviolet A (UVA) light to inactivate a broad spectrum of pathogens and leukocytes in donor platelet concentrates (PC). A next-generation LED-based illumination device, the INT200, has recently received CE mark approval. The INT200 is not approved in the US.
A series of studies was performed to compare the in vitro performance of platelets in 35% Plasma/ 65% PAS-3 treated with the INT200, or its predecessor, the INT100, and stored up to 7 days. The INTERCEPT® Blood System for Platelets is currently approved for 5 days in the US.
Study
Design/Methods: Apheresis PCs in 35% plasma/65% PAS-3 were pooled (N=21) and split into two identical units for treatment with the INTERCEPT Blood System for Platelets. The Control units were illuminated with the INT100 Illuminator and the Test units were illuminated with the INT200 Illuminator. In vitro platelet function was evaluated before and after treatment and after 5 and 7 days of storage post-collection.
Results/Findings: PCs treated with the INT200 Illuminator (Test) and the INT100 Illuminator (Control) had platelet counts and mean platelet volumes (MPV) that trended similarly over the 7-day storage duration.
pH-values (22oC) at end of storage were similar between each Test and Control unit and remained above 6.7. There were no statistically significant differences in platelet metabolism parameters (pH, lactate, glucose, and adenosine triphosphate (ATP)).
Flow cytometry analysis was performed to assess retention of granular and cytoplasmic contents. There were no statistically significant differences observed in phosphatidylserine (PS) exposure, a marker for platelet activation and apoptosis. There was a small, but statistically significant difference in P-selectin expression, a marker of α-granule secretion. The mean difference between Test and Control was small, suggesting similar levels of activation. There were no differences in Supernatant LDH as % Total LDH.
Extent of shape change (ESC), hypotonic shock response (HSR), and platelet morphology analyses were performed as measures that may predict in vivo recovery, survival and function. Test and Control PCs performed comparably for these parameters.
Conclusions: The results for the in vitro function studies show that platelet components treated under the specified conditions with the INTERCEPT Blood System for Platelets were comparable when illuminated with either the INT100 Illuminator or the INT200 Illuminator following 7 days of storage.
