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Absence of data on clinic's therapies provokes skepticism

KIEV, Ukraine -- Is EmCell selling effective treatments? It can be difficult to assess claims for therapies not regulated by the US Food and Drug Administration, but here is what the Globe discovered.

The clinic takes its name from the embryonic stem cell, and its website says it delivers embryonic stem-cell therapy. The actual cells it claims to use, however, are not embryonic stem cells by any conventional definition. An embryonic stem cell comes from an artificially inseminated embryo, typically about 5 days old, and EmCell obtains its cells from aborted fetuses between 2 and 8 weeks old. EmCell's director, Dr. Alexander Smikodub, who said he helped develop the treatments, initially said in an interview that the cells he uses, like embryonic stem cells, are "pluripotent," or able to transform into any cell in the body. But on closer questioning, he said that cells taken from different parts of the fetus are able to become different types of adult cells, but that none of the cells is pluripotent.

Behind Smikodub's desk hang more than a dozen patents granted to EmCell, most of them by the government of Ukraine. EmCell has two US patents, which describe using cells from aborted fetuses to treat AIDS, but not the many other diseases that the clinic lists on its website.

A patent, moreover, is no indication that a technique actually works, said Janis Fraser, who reviewed EmCell's patents for the Globe and is a principal in the Boston office of the law firm Fish & Richardson. A patent is a claim of invention, and the patent office's main function is to verify that an invention is original. It does not test effectiveness. In the United States, the FDA is charged with evaluating whether a treatment is safe and effective. An FDA spokesperson said that the agency has no information on EmCell.

The EmCell website contains numerous scientific reports, which it calls "publications." But none have been published in a journal reviewed by other scientists, meaning that they hold no more weight than an advertisement. Smikodub said that he would like to publish his results in peer-reviewed research journals. He said he submitted one report, on his AIDS therapy, to a journal, but it was rejected without explanation.

The rest of the website is filled with claims, but lacks the kinds of basic information needed to persuade other doctors and scientists that a procedure is worthwhile -- one of the clinic's main goals, Smikodub said.

There is no detailed description of what cells are used in the treatment. There is no discussion of how these cells are purified or tested. There is no discussion of how, precisely, the cells function in the body, or whether any experiments have been done to analyze this. There is no discussion of what the cells do, biologically, to help with any of the many diseases EmCell treats. The data the clinic provides on its experience with humans are so vague that the doctors who reviewed the material for the Globe said they couldn't draw any conclusions about its work.

The ALS Therapy Development Foundation, a Cambridge-based nonprofit organization, investigates potential cures for ALS (also known as Lou Gehrig's disease). After hearing that patients with amyotrophic lateral sclerosis were traveling to EmCell for treatment, the foundation interviewed Smikodub and sent him more questions by e-mail. Smikodub was evasive on many points, according to a report on the foundation's website. The report warns ALS patients that there was no evidence the therapy works, and there are many reasons to be suspicious.

During his interview with the Globe, Smikodub repeatedly emphasized that he uses what he called "the clinical method." He might not know all of the detailed biology of the cells, he explained, but he is sure that they help. He has not tested this procedure on animals. What this means is that he is experimenting on humans.

Smikodub does not seem to be taking even basic steps to discover what effect the treatment has on the more than 1,000 patients he claims to have treated. According to the EmCell patients interviewed by the Globe, the clinic makes no effort to question its patients at regular intervals, which would be necessary to understand what happens in the months and years after an injection.

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