Regulatory, ethical, and technical considerations on regenerative technologies and adipose-derived mesenchymal stem cells
Thorough analysis of SVF obtained from the Microlyzer showed a total nucleated cell count within the range of 5.5 million and 7.92 million , viability data was found to be close to 90%, furthermore sample examination using flow cytometry technique revealed that 3.8% were Mesenchymal Stem Cells.
Background: Since the early days of molecular biology, organ and tissue regeneration represents a challenging medical goal. However, only recently the advances in the understanding of the cellular components have enabled the promise to become a reality. In this vast panorama of new technologies, stem cells have progressively established themselves as the most effective and user-friendly regenerative therapeutic tool.
Methods: Scientific meetings, workshops, conferences, and forums focused on translational science of regenerative technologies are today blooming all over the world. The audience questions and, even more, the very often controversial and conflicting explanations highlight the great deal of confusion regarding this new discipline that should be considered today a real independent medical specialty, requiring long-term studies and dedication.
Results: All the technologies able to separate and concentrate the adipose tissue (AT) and the stromal vascular fraction (SVF) and their related clinical applications need to comply with a complex but still unclear regulatory frame, becoming everyday more severe and restrictive, this limiting their practical use.
Conclusions: The aim of this manuscript is to overview the current status of the regulatory frame and few related ethical considerations and to describe the evolution in the way the adipose-derived stromal vascular fraction (SVF) is isolated, extracted, and concentrated, as well as, of the ongoing researches and related future perspectives. Considerations on the most controversial and still unclear points related to the regenerative medicine and surgery, seen from the perspective of a research group who dedicated their entire professional life to this field, are also provided. Level of evidence: Level V, therapeutic study.