Abstract
Adipose stromal/stem cells (ASCs) are an ideal cell type for regenerative medicine applications, as they can easily be harvested from adipose tissue in large quantities. ASCs have excellent proliferation, differentiation, and immunoregulatory capacities that have been demonstrated in numerous studies. Great interest and investment have been placed in efforts to exploit the allogeneic use and immunomodulatory and anti-inflammatory effects of ASCs. However, bridging the gap between in vitro and in vivo studies and moving into clinical practice remain a challenge. For the clinical translation of ASCs, several issues must be considered, including how to characterise such a heterogenic cell population and how to ensure their safety and efficacy. This review explores the different phases of in vitro and preclinical ASC characterisation and describes the development of appropriate potency assays. In addition, good manufacturing practice requirements are discussed, and cell-based medicinal products holding marketing authorisation in the European Union are reviewed. Moreover, the current status of clinical trials applying ASCs and the patent landscape in the field of ASC research are presented. Overall, this review highlights the applicability of ASCs for clinical cell therapies and discusses their potential.
Highlights
Cell-based therapies are a novel approach to treat medical conditions that have limited or no effective therapeutic options
adipose stromal/stem cells (ASCs) are already being used in clinical applications, e.g., for the treatment of autoimmune diseases such as Crohn’s disease [10], and as a regenerative therapy for craniomaxillofacial bone defects [11]
Careful characterisation of an ASC population is the first step towards determining its viability for clinical applications
Summary
Cell-based therapies are a novel approach to treat medical conditions that have limited or no effective therapeutic options. The present review encourages this translation and defines critical aspects when aiming at the clinical use of ASCs. Human ASCs are multipotent progenitor cells found in adult adipose tissue [2]. ASCs have the ability to reduce inflammation, mediated primarily via paracrine effects [6, 7, 9, 34, 35] Both SVF and ASCs are currently utilised in clinics, but selecting between these two should be based on the particular disease application. It has been suggested that each fat depot has distinct developmental origins [33, 39], which will potentially affect cell characteristics that are critical in the context of expansion, differentiation, and therapeutics [44]. ASCs obtained using both isolation methods have equivalent viability and differentiation capacity
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