A short-term plastic adherence incubation of the stromal vascular fraction leads to a predictable GMP-compliant cell-product

Stephan Born, Max Doerfel, Philip Hartjen, Ali Haschemi, Julia Luecke, Juliane Meutsch, Julie Westphal, Moritz Birkelbach, Robert Helmuth Koehnke, Ralf Smeets, Michael Krueger


Mesenchymal stromal/stem cells derived from fat tissue are an encouraging tool for regenerative medicine. They share properties similar to bone marrow derived mesenchymal stromal/stem cells but the amount of mesenchymal stromal/stem cells per gram of fat tissue is 500x higher. The fat tissue can easily be digested by collagenase, releasing a heterogeneous cell fraction called stromal vascular fraction (SVF) which contains a variable amount of stromal/stem cells. In Europe, cell products like the SVF derived from fat tissue are considered Advanced Therapy Medicinal Products (ATMPs). As a consequence, the manufacturing process has to be approved via GMP-compliant process validation. The problem of the process validation for SVF is the heterogeneity of this fraction.



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