Joris van Dongen

336 Chapter 14 Consequently, the clinicians should protect the patient from their own overestimated believe that stem cells are the solution for every medical issue and should not nurture this belief. Clinicians, irrespective of their specialism, are all taught to act according to the four basic medical ethical principles: patient autonomy, beneficence, non- maleficence and respect for human rights. In this perspective many clinicians, who treat patients for skin rejuvenation purposes beyond clinical trials, fail to act according to one or more of the aforementioned principles. Also, researchers could and should play an important role in this respect by generating awareness among clinicians and patients about the facts and fables of ASCs and stem cells as well as lipofilling for skin rejuvenation and other clinical purposes. Progress in the field of regenerative medicine can only be accomplished if all parties i.e. clinicians, researchers, patients and industry work together in a respectful manner and learn to communicate in an understandable way. Moreover, protection of the patients can only be offered when treatments are fully understood and are evidence-based: this is not the case when evidence is based on case reports, (too) small clinical studies (often without control groups) and retrospective studies and this is not in line with the Declaration of Helsinki. The Declaration of Helsinki states that individuals have the right to make self-determined informed decisions regarding the participation in research. When the evidence is based on case reports, small clinical studies and retrospective studies, individuals have the right to be informed about it. Thus, randomized clinical placebo-controlled clinical trials are definitely warranted, when feasible, before treatments are offered as being evidence- based and real problem solving in regular and commercial medicine. It is clear that tSVF is not the solution to all (non)-medical problems. Clearly, physiological processes, such as ageing of the skin, cannot be reversed by a single injection of tSVF. Further research should focus on diseases and disorders that would potentially benefit from (multiple) tSVF injections. This thesis showed that tSVF is able to interfere in pathological processes, especially processes with excessive collagen deposition, a lack of angiogenesis or being pro-inflammatory. Moreover, tSVF obtained by the FAT procedures contains a high concentration of all regenerative components in a small volume: cellular fraction as well as extracellular matrix (Fig. 1). 11,12 Hence, tSVF might be a future therapeutic option where only small amounts of volume can be injected e.g. osteoarthritis of carpometacarpal or temporomandibular joints. An important part of the pathophysiology of osteoarthritis is the pro-inflammatory state of the joint causing an excess of pro-inflammatory mediators e.g. cytokines, prostaglandin E2 and nitric oxide production resulting in disabling pain. 41 An in vitro study showed a decrease of prostaglandin E2 production by inflamed synoviocytes co-cultured with cSVF. 42 Reduction of prostaglandin E2 production by synoviocytes might be causing reduction of pain after injection of (c- or t-)SVF clinically as mentioned in case series.