Michael Gross looks at ethical issues raised by the business in stem cells.

Advanced Cell Technologies, based in Worcester, Massachusetts, have developed a new procedure to create ‘ethical’ human embryonic stem cells, by removing single cells from early embryos in such a way that the remaining cells still remain viable. Considering the fact that the embryos in question are ‘leftovers’ from IVF that will be destroyed anyway, some observers have questioned the relevance of this work. However, in the long term, it may open the possibility of creating a line of matching stem cells for every baby born by IVF.

Meanwhile, another company, called Advanced Cell Therapeutics, has launched an effort to cash in on the hopes created by the developments in the stem cell field. It promises to cure a whole range of unrelated diseases, from Alzheimer's through to multiple sclerosis, by injecting patients with stem cells from umbilical cord blood. After removal of red and white blood cells, the remaining population consists mainly of so-called CD34⁺ cells, from which white blood cells are eventually regenerated.

While the use of such cell preparations against specific blood disorders might still be plausible, experts are bewildered at the company's claims that their stem cells can be used to treat afflictions of the nervous system, such as multiple sclerosis.

“This is not the natural choice of stem cell population to treat such disorders,” says Paul Fairchild from Oxford's Sir William Dunn School of Pathology, “so the chance of observing any clinical benefit is minimal.”

The reassuring news is, however, that, other than a possible allergic reaction, the umbilical cord cells are not very likely to cause any damage either. Even though the white blood cells have been removed from the preparation, Fairchild still expects that the cells will be rejected by the recipient's immune system and eliminated within days. Thus, they will do no harm, and any long-term change in the patient's condition is likely to be a manifestation of the placebo effect.

Thus far, the most contentious aspect of the whole enterprise is that it charges some of the most desperate and vulnerable members of society, those with incurable chronic illnesses, a substantial sum of money (newspapers reported a price of £12,000 for the injection) by offering a hope built on a treatment that has no foundation in science and has not been validated by any controlled clinical trial.

However, a recent investigation by the BBC's Newsnight program revealed an even more worrying aspect. According to the program, the stem cell ‘cures’ which Advanced Cell Therapeutics sells via clinics in various countries, including Spain and the Netherlands, originate from a company called AllCells, which produced these cell populations purely for in vitro research purposes. Representatives of that company pointed out that their cells are not guaranteed to be free from bacterial and viral infections to the standards that would be required for medical use.

Dilemmas: The potential in human stem cells is also throwing up new ethical issues. (Photo: Andrew Leonard/Science Photo Library.)

The BBC program also alleges that Advanced Cell Therapeutics tried to obscure the origin of the cells by storing them in the UK, using the services of companies that were led to believe that these cells were for research purposes only. Following the revelations, however, this route is likely to be blocked, as the medical use of such cells would be illegal in the UK and even their handling and storage for other purposes than research might violate the Human Tissues Act drawn up in response to the organ retention scandals (Curr. Biol. 14, R254).

“It is important not to judge the potential future benefits of stem cell biology from the actions of those who have shown such flagrant disregard for the lives of their patients.”

In a global market, however, people will continue to find ways of offering dubious medicine, using internet marketing and legal loopholes in countries around the world. Advanced Cell Therapeutics, for example, has been carrying out its treatments in Ireland until recently, and, when the authorities stepped in, there were press reports suggesting that the company offered the treatment on board a ferry, in international waters instead.

Similarly, the company Medra, based in Malibu, California, offers injections of “human fetal stem cells” to treat diseases ranging from Alzheimer's through to ulcerative colitis, to be carried out in the Dominican Republic. The company's fact sheet guards tactful silence on the origin of these cells.

Fairchild concludes: “While the practice of companies such as Advanced Cell Therapeutics and Medra is truly shocking, it is important not to judge the potential future benefits of stem cell biology from the actions of those who have shown such flagrant disregard for the lives of their patients.”

So, is there any real hope for patients with chronic disease to benefit from stem cell therapies in the near future? Most treatment options that are being investigated in the lab right now will need many years before they might reach the patient. However, there is some more promising, if cautious, news on stem cells. The company Geron, based at Menlo Park, California, is testing a range of stem cell treatments in preclinical trials, and is expecting to start the first Phase I clinical trial early next year, which will most likely involve a possible treatment for acute spinal cord injury.