Contemporary developments in the biosciences associated with new biological possibilities – such as seen in synthetic biology, embryonic stem cell research, and gene therapy – also depend on the articulation and integration of different sciences and technologies, such as engineering, physics, and biology within synthetic biology. As a result, the epistemic and professional boundaries of these biosciences are similarly fluid, highly mobile, and yet to be stabilised. While the matter of disciplinary boundaries and their formation is of interest to those within the field of science and technology studies, what has been of especial interest is the ways in which these biosciences not only generate new biological but also social possibilities by disturbing our understanding of the boundaries between the body, nature, and identity (not least in the form of human/animal hybrids), and how these create new ‘bio-objects’ that are contested, exploited, and require the search for new forms of state and societal regulation and governance (Vermeulen et al., 2012). Indeed, these changes can be so fundamental as to require a radically new approach to the human ‘constitution’, in both its biological and socio-legal senses (Jasanoff, 2011).

As a field of inquiry, regenerative medicine has attracted major commercial, clinical, political, and popular interest as well as controversy, illustrated by the 2008–2009 debate in the United Kingdom over the licensing of research on so-called ‘admixed embryos’, the combination of human and animal cells. The contested nature of the area has attracted growing social science interest, with most work focusing principally on human embryonic stem cells (hESC) (e.g., Eriksson and Webster, 2008; Wainwright et al., 2008; Webster and Eriksson, 2008; Gottweis et al., 2009; Ehrich et al., 2010), the emergence of the ‘tissue economy’ (Waldby and Mitchell, 2006), and the relation between this field and a longer-standing history of managed reproduction and the manipulation of ‘life’ itself (Franklin and Roberts, 2006). This book builds on this body of work in an attempt to provide as broad-ranging an analysis of the current meaning and impact of regenerative medicine as possible, drawing on a number of different perspectives that provide a critical assessment of the science base and its geographical reach, the parallel hype and promise associated with the field, the uneven and often failed commercial exploitation we have seen, and the political, legal, and bioethical challenges that developments in the regenerative medicine field pose. It does this at a global level, including a detailed analysis of what we are seeing in the United States, Europe, China, and Australia.

In this introductory chapter I provide, first of all, a brief account of the basic characteristics of the field for those less familiar with the area, and then move on to discuss the ways in which different social actors within and outside of science have sought to define and stabilise its meaning and boundaries, and how other processes continually work against this. In doing so I examine how regenerative medicine is mobilised precisely through these contrasting processes and how these different ‘mobilities’ reflect different purposes and interests that are in tension with each other. I argue that the primary form through which regenerative medicine is developing is through a scientific/corporate/regulatory nexus that is central to the economic and clinical mobilisation of the field. However, this confronts other forms of mobility – found within the corporeal and institutional domains – that pose challenges to the development of the field. I close the chapter by arguing for a ‘techno-geography’ of regenerative medicine (Oudshoorn, 2011) in order to locate the pathways and spatial configurations of the field that could emerge in the future. The chapter then concludes with an outline of the book.

Boundaries of a field are especially difficult to determine where a field is framed by its proponents as ‘revolutionary’, or as offering a new paradigm for theory and practice, here even likened to the radical change the arrival of Web 2.0 meant for the Internet (Mason, 2007). The two most notable developments in regenerative medicine that might be associated with this language of change were the identification and isolation of hESC, by Jamie Thomson in his lab at the University of Wisconsin–Madison in 1998, and the more recent (2007) creation, by Yamanaka at the University of Kyoto, of ‘induced pluripotent stem cells’ (iPS) that have the biological potential of embryonic cells without being derived from embryonic tissue as such but from reprogrammed ‘adult’ (mature, already differentiated) human cells such as skin cells.

The long-term goal of regenerative medicine is to harness the regenerative potential of both hESC and iPS cell lines to restore functionality in the body. Both types of cell lines can, in theory, be used to generate primary tissues and organs through their controlled differentiation in the lab and subsequent transplantation into the human (or animal) body. For example, biomedical scientists are working on restoring heart function through the injection of a specific type of cell line – cardiomyocytes – that has been modified to act as heart muscle. Prior to this regenerative paradigm, the field was primarily associated with ‘tissue engineering’ which, with a focus more on replacement, can be traced back some 30 years, involving the use of cells and biomaterial compounds to rebuild damaged body tissue, through skin grafts or bone and cartilage repair, or the use of mature healthy cells transplanted therapeutically to treat haematological (blood) disorders, such as bone marrow cells used to treat childhood leukaemia. A major limitation in the earlier days of tissue engineering was the lack of organs – such as the kidney – available for transplantation, and even when they were available, their use would produce a strong immunological response and the likelihood of rejection by the recipient’s body. This matter of the immune response has bedevilled the field and the hope, though yet to be realised, is that hESC and iPS lines may be less immunogenic than normal implants. Even if the immune response can be controlled, a further complication is in preventing cells, once implanted, from becoming carcinogenic (so in the case of iPS cells ensuring the reprogramming is actually secured and stable). On both counts, patient safety is a critical issue. It is important to note that neither hESC- nor iPS-based therapies are yet in clinical use, though a number are undergoing early-stage clinical trials, with large pharmaceutical companies very much adopting a cautious approach to investing in the area (see McKernan et al., 2010).

At present the clinical use of cell therapy techniques and products is in the domain of (non-iPS) ‘adult’ cell lines, using what are called ‘autologous’ (i.e., the patient’s own) cells. However, while there are some treatments on the market (such as cartilage repair), the cost of developing products, the cost of production, and the size of the markets are all factors, which mean that time to clinical use will take many years for most products currently in development. Successful products and/or procedures are likely to be those that have early links with clinicians who understand precisely what they need and how the delivery system will be able to make new offerings accessible and practicable, in terms of quicker application, greater longevity, and/or enhanced efficacy measurable by clinical end points. Further consideration of this question of product development and associated innovation ‘pathways’ is provided in much more detail in Chapter 3.

The stabilisation and thereafter exploitation of any field requires action which in some way defines and marks off its boundary: the ‘closure’ here is not meant to suggest the closing off or the insulating/isolating of an area but rather establishing the terms on which it claims some degree of warrant, authority, and identity with which those outside the boundaries of the field can and do engage, perhaps better envisaged as a form of ‘enclosure’. This involves the policing and disciplining of those working within the field. But this is a process which, paradoxically, affords mobility, scale-up, and globalising effects that can ‘act at a distance’ (Latour, 1987).

Gieryn’s (1983) conception of ‘boundary work’, initially used to identify the social (rather than any privileged epistemic) bases on which science is demarcated from ‘non-science’, has been deployed, not least by Gieryn himself (1995) and others (e.g., Bijker et al., 2009) to examine the ways in which scientific boundaries are established more generally, through a mix of individual and collective negotiation, action, and synergy. Gieryn defines boundary work as ‘the attribution of selected characteristics to [an institution] (i.e., to its practitioners, methods, stock of knowledge, values and work organization)’ (p. 782). As noted above, this involves the disciplining of a field, and this typically is secured across regulatory and innovation networks through standardisation of experimental protocols, data sets, registries of results, shared units of measurement, and agreed criteria for evaluating outcomes (Bowker and Star, 2000). This closure around specific standards in the regenerative medicine field (Eriksson and Webster, 2008 allows what has elsewhere been called the generification of technologies (Pollock and Williams, 2009) wherein the alignment of technologies, expectations, and effects is secured beyond an immediate domain and where tacit, localised knowledge is flushed out (Keating et al., 1998). Movement within and beyond the specific regenerative medicine landscape then becomes possible. So, for example, a key issue in the field has been the prolonged attempt to secure agreement over the biological ‘markers’ or signifiers that indicate cell type, whether, for example, a cell line is simply deemed to be ‘research grade’ rather than the (more demanding) ‘clinical grade’, and so on. As agreement over such markers is secured, mobility grows: we might say that the globalisation of markers enables the globalisation of markets.

There are a number of ways in which we can see this stabilisation and policing being undertaken by those within the scientific/corporate/ regulatory nexus. Global stem cell research networks have been established by leading labs including those from Europe, the United States, Japan, and Australia as members of the International Stem Cell Initiative to police the production of stem cell lines via standard operating protocols and the identification of materials to reduce variability across labs, such as the move towards agreeing to a ‘defined media’ to help the reproducibility of cell batches, remove potential sources of contamination or confounding factors, and enable the comparability of results across labs in different countries. Not only scientists but companies too (those providing the media) have been involved in this process.

A second way in which we have seen boundary closure at work is in regard to the move towards the automation of cell culture/management techniques through scientific equipment manufacturers involved in whole cell bioprocessing. Automation is, as Bartlett (2009) has eloquently suggested, ‘the material reification of rationalisation’ (p. 75) and in turn helps relieve the tedious work of manual handling of cell batches, their extraction, and the validation of results. It presupposes agreement over how variability in cell lines is to be understood and treated within automated systems, and presumes thereby that what is scaled up has a robust degree of consistency and uniformity. Regulators are very closely involved here since they require this degree of consistency and reproducibility in approving the move towards clinical trials.

A further way in which boundary stabilisation can be secured is through the establishing of what can be called international trading zones through bi- or multilateral stem cell banking agreements that are designed to regularise and agree on (ethical and quality) standards in respect to the procurement of cell tissue, and in the medium to longer term define the criteria through which banks can determine what are ‘clinical’-grade lines that would be safe to deploy in clinical trials, and which would be required to meet the terms of the European Tissue and Cells Directives (ETCD) (published between 2004 and 2006). Such agreements (e.g., between the UK and Spanish national stem cell banks) allow for banks to exchange tissue on the assumption that this carries the same socio-technical and regulatory qualities, a form of tissue currency that is seen to be of equivalent material and social value. Reference to the ETCD also points to the way in which the field has seen the growth over the past decade of new forms of regulatory oversight through national and international agencies, notably by the European Medicines Agency and the US-based Food and Drug Administration (FDA). At the same time, the currency of tissue is also expressed in its commodification, which thereby raises questions about the sourcing of tissue, and the political and rights implications of the bioeconomy, a key focus for Chapter 5.

Finally, emerging technologies are often associated with promissory expectations (see Brown et al., 2000), and policy capture can occur as state agencies are caught up in overambitious hype as a result of what has been called ‘promissory pressure’ (Beynon-Jones and Brown, 2011, p. 640). Recent work by Morrison and Cornips (2012) explores the ways in which news reportage by commercial and trade organisations within the regenerative medicine field has sought to exploit expectations of novelty and disruptive innovation (and so raise venture capital and government interest) while at the same time managing these expectations and endeavouring to frame the field as a stable and reliable site for investment: they show that the passage from the first days of regenerative medicine ‘is marked by a transition from early, wild, radical expectations to a more conventional promise that is able to be forced into the “standard” configuration of biotechnology innovation’ (p. 19).

While these various ways in which stabilisation of the field has been secured are discussed later in the book there are other processes at work which confound though do not necessarily prevent stabilisation as such. One of these relates to the materia...