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MATERIALS

A few facts

Professor Hwang, despite the recent furore, is still today undoubtedly an international authority on cloning, having successfully been the first to clone a number of different animals. In early 2004, Hwang announced that his team in Seoul had cloned the first human embryo and created a stem cell line from it. This was an amazing discovery and one that helped flame the South Korean biotechnology industry. The process to clone an embryo involves the scientist extracting a nucleus from a normal adult cell such as a skin cell and then injecting it into an egg that has previously had its own nucleus removed. In animals this is the first step in reproductive cloning, as witnessed with Dolly the sheep. For humans, reproductive cloning is expressly banned, however, the process can be potentially deployed to produce therapeutic cell lines, that is, cells for use in clinical cell therapies. The rationale being that embryonic stem cells can form any cell in the human body and therefore could be utilised to repair or regenerate any tissue or organ. However, because they are not the individual’s own stem cells, that is, they are allogeneic, the individual’s immune system would consider them to be foreign material and immediately reject them.

In May 2005, the South Korean team released results a whole order of magnitude more impressive than their earlier great achievement. This time, they announced that the team had created eleven patient-specific lines of human embryonic stem cells. These were effectively personalised embryonic stem cell lines, thus potentially resolving the whole issue of rejection. The team simply took nuclei from the patient’s own skin cells to create individual patient-specific therapeutic stem cell lines. Scientists from around the world heaped praise on the South Korean team; the cloning equivalent of the race to be the first man on the moon was decided! But not for long …

By mid January 2006, the majority of Hwang’s team’s human results had been discredited. Sensational revelations about ethics breeches, falsified data and international conspiracies have all poured forth. All the facts are still far from being known, but if ever there was potential for a great Hollywood movie, this escapade must be one!

The commercial outcome

Table I. (click to enlarge) US public companies in the stem cell and regenerative medicine sector (Market capitalisation: 3 February 2006).

Because the human cloning race has now resumed, many laboratories and companies around the world have intensified their research efforts to take the elusive prize. There is much national pride at stake as well as potential commercial gain. For example, Advanced Cell Technology (Worcester, Massachusetts, USA, www.advancedcell.com) is reported to be revamping its near-shut down therapeutic cloning programme. The triumphant announcements by Hwang in the journal “Science” in 2004 and 2005 had effectively turned off funding for therapeutic cloning; there is after all no prize for being second.

Table II. (click to enlarge) UK public companies in the stem cell and regenerative medicine sector (Market capitalisation: 3 February 2006).

Following the South Korean team’s discreditation, investment in the stem cell and regenerative medicine industrial sector have been mixed, but certainly not disastrous in anyway. The leading United States (US) companies have continued to enjoy high levels of market capitalisation (see Table I). The United Kingdom (UK) has likewise been generally unaffected by the negative publicity from South Korea (see Table II).

Indeed, January 2006 saw the successful floatation of the third company on the London Stock Exchange in the stem cell and regenerative medicine area: Intercytex plc (Cambridge, UK, www.intercytex.com). Intercytex is a cell therapy company specialising in wound care and the aesthetic medicine businesses. It raised £15 million on AIM (a market of the London Stock Exchange) to give a market capitalisation on admission of approximately £60 million.

Round up

The Hwang events are clearly a set back for the field of therapeutic cloning, which is currently an extremely small sector in the overall field of stem cells and regenerative medicine. There is a growing momentum for the argument that there is a “need to aggressively develop human embryonic stem cell technologies in countries where such research is subject to much more stringent ethical and scientific oversight.”²

The South Korean experiences have certainly had an impact on the South Korean biotechnology sector, which has experienced falling investments, although some argue that the market was over hyped as a result of Hwang’s ground-breaking announcement and it is now settling back to a more realistic level. However, the global stem cell and regenerative medicine sector remains unchanged overall and even possibly a more interesting sector for investors, for example, the recent successful Intercytex floatation on AIM. It now appears that the stem cell technology tide may have turned from the Far East and that the West, and the US and UK in particular, may benefit most from recent events in South Korea.

Chris Mason, PhD FRCS, Regenerative Medicine Bioprocessing Unit, Advanced Centre for Biochemical Engineering, University College London, Roberts Building, Torrington Place, London WC1E 4JE, UK, tel. +44 20 7679 0140, fax +44 20 7209 0703, e-mail: chris.mason@ucl.ac.uk.