Objectives: To define risk following systemic/intravascular administration of adipose-derived stromal vascular fraction (SVF) and cultured cells derived from SVF.
Introduction: The stromal vascular fraction of adipose tissue has considerable clinical potential due, in part, to the heterogeneity of its cellular composition. However, this population is derived by the digestion of a three dimensional tissue (adipose). This creates special concerns when the cell product is to be delivered into the vascular system with the consequent risk of embolism and stimulation of platelet aggregation.
Materials / method: Not applicable
Results: Risks derive from both byproducts of tissue disaggregation and from the cells themselves. By-products with risk include: tissue aggregates from incomplete disaggregation; collagen fragments; extracellular lipids; and extracellular DNA. SVF cells include vascular endothelial cells, smooth muscle cells, fibroblasts, stem cells, and leukocytes. Some of these cell types express Tissue Factor which plays a key role in the clotting process. Tissue Factor is also highly expressed in cultured cell populations derived from SVF, in particular, adipose-derived stem or stromal cells (ADSCs).
Conclusion: Systemic administration of SVF or cells derived by culture of SVF must take each of these risks into consideration and apply systems and processes by which risk is eliminated or managed, the success of these approaches in adequately mitigating these risks must also be demonstrated in in vivo preclinical testing before the SVF or SVF-derived product may be used clinically.
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