reportFocus Report 2010: Nanotechnology in Regenerative Medicine
7.2 Executive Summary
Regenerative medicine is widely seen as one of the the next revolutions in medical treatment. It draws heavily from the fields of tissue science, biology, biochemistry, physics, chemistry, materials science, applied engineering and other fields and is a highly interdisciplinary new discipline. The general aim of regenerative medicine is to repair, replace or regenerate lost or damaged tissues and organs in vivo through techniques that stimulate them into healing themselves. Tissues and organs can also be grown in vitro for subsequent implantation into the body.
Regenerative medicine is considered to have the potential for developing new treatments for previously untreatable, or difficult to treat, diseases and conditions including diabetes, heart and vascular disease, renal failure, musculoskeletal defects and injuries, osteoporosis, and peripheral nerve and spinal cord injuries. Virtually any disease that results from malfunctioning, damaged, or failing tissues may have the potential to be treated through regenerative medicine techniques.
This report provides a brief overview of some of the key developments and approaches in regenerative medicine, together with profiles of some selected companies operating in the field.
A demographically-ageing population in the majority of Western countries means that there is an increasing incidence of diseases related to ageing such as cardiovascular disease, cancer, musculoskeletal and degenerative conditions. While there have been great advances in material science and in medical device design related to medical prostheses such as hip, knee and cardiovascular implants, which today often constitute part of the normal treatments for such conditions, such devices often have a finite life within the challenging environment of the body and can give rise to complications during revision surgery to replace them at the end of their working life..
Regenerative medicine offers a potential solution to many of these clinical needs and challenges in the sense that it seeks to replace, repair or otherwise stimulate the replacement of the patient’s diseased or damaged tissues with new similar tissue, usually derived from the patient themselves, thereby restoring function. Unlike many pharmaceuticals which merely “manage” a condition, regenerative medicine aims to cure or repair rather than treat symptomatically
During the 1990s and early part of the current decade the main focus of research and development was in the field of tissue engineering in which scaffolds formed of suitable biomaterials were combined with cells (autologous or allogeneic, i.e. from the patient themselves or from another person) and growth factors ex vivo, grown in a suitable bioreactor, and then applied surgically to the patient. However, the lack of a suitable regulatory pathway in Europe and uncertainties over possible adverse effects such as tumourogenicity meant that few engineered human tissue products have been developed or brought to the market in Europe. While the the Advanced Therapy Medicinal Products Regulation came into force late in 2007 and now covers such the placing on the market in Europe of such products, and while there is likely to be an important and growing market for such products, there is nevertheless likely to be a lengthy regulatory approval period before novel tissue engineered products begin to appear on the European market. In the US, the only products so far available on the market are first generation engineered skin and cartilage products although the US Department of Health and Human Services has estimated a future market of $100 billion for regenerative medicine products.1
Over the past decade, there has been a shift in interest in many centres of research towards the regeneration of human tissues in vivo. Here, the focus is to design implantable biomaterial scaffolds that provide a suitable physicochemical environment in which cells can grow and differentiate and to use the body itself as a “bioreactor” to grow the desired replacement tissue. This offers many potential advantages in that the cells are the patient’s own, thereby avoiding risk of rejection or transmission of infectious agents, and a providing a potentially shorter regulatory route to the clinic. A further major focus of research has been on the role and use of stem cells in regenerative medicine and control of their differentiation into the desired tissue type. Cell and gene therapies are, like tissue engineering, covered by the European Advanced Therapy Medicianl Products Regulation but are, however, specialised topics in their own right and are not addressed in this report
This report provides an explanation of the novel technologies that comprise regenerative medicine together with some examples of products in development and company profiles. It provides an indication also of where knowledge at the nanoscale and nanotechnology are being actively applied to underpin and improve the performance of regenerative medicine processes and products.
While regenerative medicine, and the application of knowledge at the nanoscale to further underpin its processes and products, holds considerable promise from the perspective of meeting unmet clinical needs and patient benefit, and while the academic and research base in Europe is also strong, there are a number of important challenges and barriers to be overcome in relation to commercialisation and to clinical uptake which are highlighted in this report.
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