Standardization of platelet releasate products for clinical applications in cell therapy: a mathematical approach

Journal of Translational Medicine
Francesco AgostiniMario Mazzucato

Abstract

Standardized animal-free components are required for manufacturing cell-based medicinal products. Human platelet concentrates are sources of growth factors for cell expansion but such products are characterized by undesired variability. Pooling together single-donor products improves consistency, but the minimal pool sample size was never determined. Supernatant rich in growth factors (SRGF) derived from n = 44 single-donor platelet-apheresis was obtained by CaCl2 addition. n = 10 growth factor concentrations were measured. The data matrix was analyzed by a novel statistical algorithm programmed to create 500 groups of random data from single-donor SRGF and to repeat this task increasing group statistical sample size from n = 2 to n = 20. Thereafter, in created groups (n = 9500), the software calculated means for each growth factor and, matching groups with the same sample size, the software retrieved the percent coefficient of variation (CV) between calculated means. A 20% CV was defined as threshold. For validation, we assessed the CV of concentrations measured in n = 10 pools manufactured according to algorithm results. Finally, we compared growth rate and differentiation potential of adipose-derived stromal/stem cells (ASC)...Continue Reading

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Citations

Apr 28, 2018·Journal of Tissue Engineering and Regenerative Medicine·E BaumanC C Barrias
Jun 3, 2021·International Journal of Molecular Sciences·Michaela OellerKatharina Schallmoser
Aug 28, 2021·International Journal of Molecular Sciences·Stefano PulciniThelma A Pertinhez

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Methods Mentioned

BETA
ELISA
Assay
Electrophoresis
phase contrast
platelet

Software Mentioned

R

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