Abstract
Clinical and non-clinical work within the last decade has changed the conventional thinking about platelets. In addition to hemostasis, platelets are now recognized as playing a major role in wound healing, immune modulation and tissue regeneration. Autologous platelets are gaining acceptance for various wound healing applications while allogeneic platelets are still reserved for infusion for hemostasis. The biggest disadvantage is that these platelets have a shelf life of 5 days. Lyophilization is one technique that has been evaluated to increase the shelf life of platelets and almost all lyopilization techniques use some kind of preservative or sugars. We have developed a process of lyophilization for allogenic platelets which are past their useful life for infusion but are still quite well suited for seeding provisional matrix within wounds. This process doesn’t use special additives and optionally includes terminal sterilization to yield an efficient, safe, off-the-shelf, freeze-dried product. This product was characterized by residual moisture content and presence of key growth factors (PDGF, TGF-b1, FGF and VEFG). All these growth factors are able to stimulate cell proliferation, matrix remodeling and angiogenesis in wound healing. An extensive analysis of these growth factors in the product postprocessing indicated that their values (per 106 platelets) were very close to values obtained from fresh platelet rich plasma from healthy volunteers. Comparisons of growth factors were conducted to detect differences between methods of sterilization and different vial materials used in the lyopilization process. Functional assays were conducted to verify the activity of the freeze-dried product. All tests showed that the processed product maintains the growth factor levels and cell stimulation activity appropriate for seeding the provisional matrix in a topical or surgical wound.
Published Version
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