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Stemedica warns against turning to unregulated clinics

The stem cell research company planning to operate in Bermuda has issued a warning to sick people seeking treatment overseas after a young patient reportedly suffered horrific side effects.

California-based Stemedica says the method used in Russia — said to have caused a brain tumour for an Israeli boy — was vague and posed numerous risks.

"We want to use this unfortunate incident to warn those seeking stem cell therapy abroad to make certain that the manufacturer of the stem cells used in transplantation comply with the rigid standards that have been established by the FDA and other internationally-recognised regulatory agencies," said President Nikolai Tankovich in a statement on Stemedica's website.

Vice President Alex Kharazi states Stemedica, which currently operates in Russia, Mexico, Korea and Switzerland, follows FDA guidelines for the manufacturing and testing of stem cells.

Stemedica's link-up with the Brown-Darrell Clinic in Winterhaven, Smith's — run by Premier Ewart Brown and wife Wanda — has attracted fierce criticism itself because of Bermuda's lack of stem cell legislations.

On hearing about the proposal in 2007, International Society for Stem Cell Research President George Daley said he was sceptical of any group running experimental treatment in jurisdictions without regulatory oversight.

Dr Daley warned desperately ill patients not to be misled into thinking stem cells are a miracle cure.

The Brown-Darrell Clinic has pledged to welcome and encourage legislation consistent with the international protocol practised by countries engaged in stem cell work, but has repeatedly failed to respond when asked if it will postpone opening the stem cell side of its operation until such legislation is in place.

The Ministry of Health has said it will put stem cell guidelines in place as an interim measure, but admitted they will not have the teeth of regulations.

According to reports, the Israeli boy started flying to Russia for repeated transplants of fetal neural stem cells when he was nine in 2001.

Four years later, he was diagnosed with a brain tumour which had grown out of stem cells obtained from at least two aborted foetuses. The Winterhaven project will use adult stem cells rather than embryonic.

Meanwhile, Stemedica has announced it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for US-based clinical trials.

CEO Maynard Howe stated on the website: "Completion of this certification will allow us to manufacture stem cells under contract for clinical trials for Stemedica as well as for other companies and research centres in California and across the United States.

"This marks a significant milestone along the journey toward the future availability of stem cell treatment for patients who so urgently need it."

A public forum titled 'Stem cells for research and transplantation: myth and realities' takes place at Bermuda College's North Hall Lecture Theatre next Wednesday at 7 p.m.

It will feature a talk from cancer research and stem cell pioneer Curt Civin, associate dean of research and founding director of the new University of Maryland School of Medicine Center for Stem Cell Biology.

Dr Civin will address questions including: What are stem cells? How are they made?

How can they be used clinically in the future? What about their use in humans?