Autologous therapies using platelet‐rich plasma (PRP) need meticulous preparation—currently, no standardised preparation technique exists. Processing Quantitative Standards (PQSs) define manufacturing quantitative variables (such as time, volume and pressure). Processing Qualitative Standards (PQLSs) define the quality of the materials and methods of manufacturing. The aim of this review is to use existing PQSs and PQLs to report the in vivo/in vitro results obtained by using different Kits, that utilise different procedures (classified as Closed‐Technique and Opened‐Technique) to isolate autologous human activated (AA‐PRP) or non‐activated PRP (A‐PRP). PQSs included the volumes of blood collected as well as the reagents used, the time/gravity of centrifugation, and the duration, temperature and tilt level/speed of centrifugation. PQLSs included the use of Calcium Chloride CaCl2, Kit weight, transparency of Kit components, the maintenance of a closed sterile processing environment and the use of a small centrifuge. Eight CE marked devices for PRP extraction were evaluated: Angel®, Biomed®, Cascade® and Selphyl®, Mag‐18®, i‐Stem®, MyCells® and Regenlab®. Using a Kit with the PQSs and PQLSs described in this study enables the isolation of A‐PRP, thereby meeting consensus quality criteria. As our understanding of Critical Quality Attributes (CQAs) of A‐PRP continues to evolve, especially with respect to purity and potency, adjustments to these benchmark PQSs and PQLs will hopefully help isolate A‐PRP of desired CQAs with greater reproducibility, quality, and safety. Confirmatory studies will no doubt need to be completed.
Gentile, P., Calabrese, C., De Angelis, B., Dionisi, L., Pizzicannella, J., Kothari, A., De Fazio, D., Garcovich, S., Impact of the different preparation methods to obtain autologous non‐activated platelet‐rich plasma (A‐PRP) and activated platelet‐rich plasma (AA‐PRP) in plastic surgery: Wound healing and hair regrowth evaluation, <<INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES>>, 2020; 21 (2): 431-439. [doi:10.3390/ijms21020431] [http://hdl.handle.net/10807/155128]
Impact of the different preparation methods to obtain autologous non‐activated platelet‐rich plasma (A‐PRP) and activated platelet‐rich plasma (AA‐PRP) in plastic surgery: Wound healing and hair regrowth evaluation
Garcovich, S.Ultimo
2020
Abstract
Autologous therapies using platelet‐rich plasma (PRP) need meticulous preparation—currently, no standardised preparation technique exists. Processing Quantitative Standards (PQSs) define manufacturing quantitative variables (such as time, volume and pressure). Processing Qualitative Standards (PQLSs) define the quality of the materials and methods of manufacturing. The aim of this review is to use existing PQSs and PQLs to report the in vivo/in vitro results obtained by using different Kits, that utilise different procedures (classified as Closed‐Technique and Opened‐Technique) to isolate autologous human activated (AA‐PRP) or non‐activated PRP (A‐PRP). PQSs included the volumes of blood collected as well as the reagents used, the time/gravity of centrifugation, and the duration, temperature and tilt level/speed of centrifugation. PQLSs included the use of Calcium Chloride CaCl2, Kit weight, transparency of Kit components, the maintenance of a closed sterile processing environment and the use of a small centrifuge. Eight CE marked devices for PRP extraction were evaluated: Angel®, Biomed®, Cascade® and Selphyl®, Mag‐18®, i‐Stem®, MyCells® and Regenlab®. Using a Kit with the PQSs and PQLSs described in this study enables the isolation of A‐PRP, thereby meeting consensus quality criteria. As our understanding of Critical Quality Attributes (CQAs) of A‐PRP continues to evolve, especially with respect to purity and potency, adjustments to these benchmark PQSs and PQLs will hopefully help isolate A‐PRP of desired CQAs with greater reproducibility, quality, and safety. Confirmatory studies will no doubt need to be completed.File | Dimensione | Formato | |
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