The Lancet, апрель 2005 Russian scientists voice concern over “stem-cell cosmetics”

Tom Parfitt

Beauty salons in Russia are exploiting a legal loophole that allows them to offer stem-cell treatments for cosmetic purposes. Scientists are now rallying against the unregulated use of these treatments to stop the practice undermining legitimate research. Tom Parfitt reports.

The Russian Ministry of Health is in the process of setting an expert council to investigate the country's huge and unregulated trade in stem-cell treatment at private clinics and beauty salons.

Officials were forced to take action at the end of March after a group of 13 eminent scientists wrote to parliament pleading for it to introduce a law prohibiting the clinical use of stem cells from embryos and aborted fetuses.

Under current Russian legislation, stem cells of any kind can only be extracted or stored, but commercial clinics get around the regulations by arguing their use in treatment is not expressly forbidden.

Research institutes are allowed greater latitude, but the guidelines are unclear and open to abuse from institutes that have partnerships with commercial organisations. Across the world, research into stem cells is still at an early stage and clinical trials on humans are rare. However, treatments using the cells—or purporting to use them—are easily available in Russia, despite being officially prohibited. Some unscrupulous scientists are thought to be in league with private boutiques and clinics in a shady but hugely lucrative business.

A slew of recent media reports has exposed the extent of the trade and there are growing fears that patients are paying tens of thousands of dollars for “wonder cures” that could cause them long-term damage. Medical professionals are hoping the expert council will rein in the trade by issuing tough new guidelines for use of stem cells in both research and clinical use.

Dozens of private clinics in Moscow offer stem-cell treatment for diseases such as Parkinson's disease and Alzheimer's disease, for diabetes, impotency, and a raft of other ailments. Among them are beauty salons that provide stem-cell treatments to cure baldness or smooth out wrinkles on the skin. The treatment can cost up to ?10 000 (US$18 740) for a series of injections.

Clinics openly advertise their services in newspaper advertisements under headlines such as “Immortality is almost possible” and “The youth injection”.

“All this—everything which is being done in Russia at the moment in terms of clinical application of fetal, embryonic, or adult stem cells—is illegal”, says Vladimir Smirnov, a professor and director of the Institute of Experimental Cardiology, who is leading the campaign for a new law.

The professor, whose institute runs a state-authorised adult stem-cell bank using cells taken from umbilical cords, says he is in favour of responsible stem-cell research. However, he and his colleagues are anxious that patients are effectively paying to be guinea pigs for untested treatments. One major concern is that patients are being injected with a blend of tissues from aborted fetuses or other material whose origin is doubtful. The Cosmeton Clinic in Moscow, for example, says it uses cells from pigs and sheep in its injections. Smirnov compared this kind of treatment to the 19th century Brown-Sequard “organotherapy” whereby human diseases were treated using extracts from animal organs.

“The only reason people feel a positive effect for a month or 6 weeks after the injection is because introducing foreign material into the body causes immuno-stimulation”, he told The Lancet.

“In fact, it is potentially very harmful. Firstly, it can cause teratomas (tumours) which could turn malignant. Secondly, you introduce infection because you cannot check all the viruses when you take material from an embryo which is developing and where the origin is unknown.”

Some patients have already spoken out about the adverse effects they have suffered. Svetlana Galiyeva, a 40-year-old gynaecologist from Perm, thought she had found the answer to her prayers when she discovered a Moscow clinic offering to treat her multiple sclerosis with embryonic stem cells. After a series of injections costing about 560 000 rubles (?10 000) she is still confined to a wheelchair. In the beginning, her body initially rejected the treatment. Her limbs then regained some sensation, but only for a short period. Doctors later advised her there was no proof her injections had anything to do with stem cells.

Another patient, the pharmaceuticals magnate Vladimir Bryntsalov, described his face being left covered with tiny tumours after supposed stem-cell treatment. Many scientists are worried that such scandals could hinder genuine research into stem cells. “There is a real risk that the state will decide to cut off funding as a result”, says Alexei Ivanov, a professor and deputy director of the Research Institute of Molecular Medicine at Moscow's Sechenov Medical Academy. His institute is studying mechanisms of differentiation of stem cells, under the auspices of the Ministry of Health.

While some smaller private clinics are reluctant to discuss their methods of stem-cell treatment, others claim they are merely exploiting a legal loophole. One of the highest-profile experts in the field is Alexander Teplyashin, head of the Moscow's chain of elite Beauty Plaza salons. He offers “absolutely unique stem cell technology” with which “it is possible to eradicate [diseases] and create a completely healthy human being”. The treatment, his website boasts, can “stop the process of ageing”.

Teplyashin and his colleagues agreed to show The Lancet around his salon in central Moscow, an immaculate building with frosted glass doors, chrome fittings, and a spiral staircase.

“We understood that people were interested in their appearance and in a long life and at the same time we realised that in stem cells there are huge resources for regeneration”, he explained. The salon uses mesenchymal stem cells taken from adipose tissue during liposuction (or a simple operation under local anaesthetic) which are isolated, cultivated, and stored. They are then administered as injections to treat hepatitis, diabetes, eye disorders, and skin problems. Most of the treatment is autologous—a procedure that is likely to be permitted under new guidelines expected to be issued by the health ministry's new expert council later this month.

However, some of the cells used are from donors. Laboratory assistants at Beauty Plaza gave a slideshow that demonstrated rapid healing of cuts and scratches on a woman's face after a car accident, achieved by applying a mask of stem cells in a gel. Another woman underwent the same procedure as a cosmetic exercise to “lift” her skin.

Teplyashin admits that such clinical uses are a grey area under current legislation but says all patients are rigorously checked and monitored before and after treatment.

“The law permits one to extract these cells and to keep them, that's all”, he says. “But what is not forbidden, is allowed.”

Several other clinics contacted by The Lancet offered stem-cell treatment for a range of ailments, with prices ranging from ?90 for a skin rejuvenation injection to ?45 000 for a full course of treatment. While different clinics acquire their material from different sources, the area of greatest controversy remains the use of material from aborted human fetuses. Smirnov believes there is a criminal trade in these fetuses, which are obtained from poor women in Russia and Ukraine who are persuaded to have late abortions. “The women are paid about $200 to have a caesarean at about 15 weeks and the fetus is then passed on to a clinic”, he said.

One Moscow-based “Stem Cells hotline” claims regular treatment with its embryonic stem cells, starting when the patient was 20, would allow him or her to live until they were 150 years old.

Andrei Loshak, a well-known investigative reporter from the NTV television channel, discovered last month that inquiries to the hotline were redirected to a state-run obstetrics centre where a series of injections into the stomach costs about ?4000. Gennady Sukhikh, director of the centre's immunology department, admitted that fetal cells were used, but told Loshak: “We work with embryos obtained from social abortions, when the termination of the pregnancy is the voluntary decision of the mother.”

Many experts insist the controversy around clinical stem cell use must not detract from the cells' real potential. “These are truly magic cells”, said Ivanov from the Sechenov Academy. “The problem is, there is still so much we don't know about them and the effects they have on the body. That's why we have to get all this unregulated practice under control.”

The Lancet, Volume 365, Issue 9466, Pages 1219 - 1220, 2 April 2005

http://www.thelancet.com/journals/lancet/