Cell therapy industry: billion dollar global business with unlimited potential

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From: Regenerative Medicine(Vol. 6, Issue 3)
Publisher: Future Medicine Ltd.
Document Type: Report
Length: 4,742 words
Lexile Measure: 1460L

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Author(s): Chris Mason [[dagger]â ] 1 , David A Brindley 2 , Emily J Culme-Seymour 3 , Natasha L Davie 4

The cell therapy industry (CTI) has undoubtedly come of age with its international base, billion dollar per year turnover and broad spectrum of proven therapies ranging from conventional organ transplantation to advanced stem cell therapies. Now is, therefore, not the time to have an identity crisis by continuing to pretend that regenerative medicine and cell therapies are one and the same -â they are not. Whilst they do overlap, they are definitely two distinct and very different entities. Regenerative medicine uses any method to replace or regenerate cells, tissue or organs in order to restore or establish normal function [1] and therefore draws upon therapies from all four pillars of healthcare: pharmaceuticals, biologics, devices and cell therapies [2] . Cell therapy is the therapeutic application of cells regardless of cell type or clinical indication -â a platform technology. Regenerative medicine is an approach to treating patients and therefore definitely not a platform technology. It is closest to a hospital specialty, for example, emergency medicine, gerontology or palliative medicine, in other words platform technology independent. Its goals are ultimately to cure and therefore a paradigm shift away from conventional symptom control and pain management. Whilst it is true that some cell therapies are regenerative, the majority are not. Just as regenerative medicine is far bigger than regenerative cell therapies alone, cell therapies collectively represent a market opportunity many orders of magnitude greater than regenerative medicine. Equating one with the other is therefore not advantageous but instead does both a major disservice. Overall, the impact of blurring the two is to confuse politicians, funding agencies, investors and most of all the public and patients [101] . So why has it happened and, more importantly, why has it perpetuated?

Regenerative medicine initially became used as a synonym for 'âtissue engineering'â and later popularized by William Haseltine (founder of Human Genome Sciences) [3] . From 2002 onwards, the term was increasingly embraced as political spin to distance the tissue engineering field from the disasters of its past -â overambitious claims and wild research programs that resulted in billions of dollars of squandered investment, zero investor confidence, and only a handful of US FDA-approved products [4,5] . Out of the decline of 'âtissue engineering'â rose the term 'âregenerative medicine'â to rescue the field (Figure 1). Initially intended to re-badge tissue engineering and other similarly focused cell-based therapies, it quickly became apparent that the term'âs depth and breadth unwittingly encompassed pharma, biotech, and device products such as recombinant erythropoietin, growth hormone and bone morphogenic protein. Unfortunately, these multibillion dollar drugs and devices totally dwarf the fledgling cell-based industry sector. Confusion has reined ever since and was compounded by President Bush with his federal funding restrictions on human embryonic stem cells, and the desire of the nonembryonic stem cell community to distance themselves from this political and ethical debate. For example, the pragmatice naming of the industry lobby group, the Alliance for Regenerative Medicine (ARM) [102]...

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Gale Document Number: GALE|A255557394