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  • The underlying justification for such adipose derived proced

    2018-10-24

    The underlying justification for such adipose-derived procedures is the assumption that the cellular extract contains mesenchymal stem Linsitinib cost (MSCs) — a type of stromal cell isolated from a wide variety of sources including bone marrow, fat, dental pulp and placental tissue and one of the most common sources of stem cells in new clinical trials over the last decade (Li et al, 2013). For the providers they are an attractive source as they are relatively easy to isolate from the patient, are reputed to be able to form cartilage, bone and muscle, and also exert immunomodulatory properties enabling them to act as an “injury drugstore” (Caplan and Correa, 2011). However, what are exactly MSCs and their use in regenerative medicine – and even whether they should be called stem cells – is a matter of significant debate within the scientific community (Bianco et al, 2013a; Shen, 2013). Interestingly, autologous cell therapies are often promoted as being ‘natural’ and having ‘no risk’ because they come from ‘you’. However, safety should not be assumed in all circumstances. The recent report of bone fragments growing around a patient\'s eye following a stem cell facelift (Jabr, 2012), as well as the lesions that developed in the kidney of a woman who received marrow-derived cells (Thirabanjasak et al, 2010), highlights the potential hazards of early adoption of unproven stem cell treatments — even when the cells come from the patient.
    Curbing provision of unproven stem cell treatments In recognition of the growth of commercial practices marketing unproven stem cell treatments, the International Society for Stem Cell Research (ISSCR) in 2007 established a task force of scientific, medical, and bioethical experts to develop a comprehensive set of performance guidelines for the clinical translation of stem cell research. These guidelines address any attempt to develop novel clinical applications of stem cells and their direct derivatives, including the use of HSCs and other somatic stem cells outside their established standards of care, specifically voicing concern about the “potential physical, psychological, and financial harm to patients who pursue unproven stem cell-based therapies and the general lack of scientific transparency and professional accountability of those engaged in these activities” (Hyun et al., 2008; ISSCR, 2008). In particular these guidelines included a series of recommendations for the responsible administration of unproven stem cell interventions outside a clinical trial context. The ISSCR guidelines allow some room for medical innovation during the course of patient care through the provision of unproven stem cell interventions, but only under very special circumstances (Lindvall and Hyun, 2009). These exceptional circumstances involve just small numbers of seriously ill patients who would be cared for under a stringent set of oversight requirements including independent peer review of the proposed innovative stem cell procedure and its scientific rationale, institutional accountability, rigorous informed consent and careful patient monitoring, transparency, speedy adverse-event reporting, and a committed plan by clinician-scientists to move toward a formal clinical trial after experience with the intervention in a few patients (Hyun et al., 2008). For all other circumstances that do not meet the criteria governing responsible stem cell-based innovative care, the ISSCR included an additional clear statement within the guidelines entitled ‘Position on Unproven Commercial Stem Cell Interventions.’ This position statement articulates in no uncertain terms that “the ISSCR condemns the administration of unproven uses of stem cells or their direct derivatives to a large series of patients outside of a clinical trial, particularly when patients are charged for such services. Scientists and clinicians should not participate in such activities as a matter of professional ethics.” (ISSCR, 2008, p. 5).