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The first stem cell drug assessment

A groundbreaking medical technology has made a step closer to reality.
The first regenerative medicine based on stem cells can be filed for
approval in Europe this year. A European manufacturer is going to
submit the first application for marketing authorization for a stem
cell-based product by the European Medicines Agency (EMEA). Drugmakers
typically send a letter of intent to the London-based watchdog four to
six months before a formal application.

The EMEA declined to name the company involved.
Official representatives from the EMEA have already met this week with
drug company officials, regulators from the United States and Japan,
and academic scientists to discuss guidelines for approving such

In recent years a number of stem cell researches has increased
dramatically. Today there are about 40 clinical trials underway in the
European Union exploring the use of stem cells to regenerate lost or
damaged tissues and tackle various cancers. Most of the scientists use adult mesenchymal stem cells.

Stem cells are are the body's master cells and can potentially be used
to repair the
heart, spinal cord, liver, pancreas, eyes and other parts of the body. They are
particularly flexible when taken from days-old embryos.
The only thing is, they are controversial and have risk, that foreign
cells might be rejected or could proliferate uncontrollably, leading
to tumors.
The EMEA has already drafted a "reflection paper" on the process for
approving stem cell-based therapies. It will be finalized by the end
of 2010.

For many investors, stem cells remain off the radar screen for now
after early excitement about the science was followed by delays and
disappointments in the clinic. But there are still a number of large
pharmaceutical companies that are also starting to invest.

For example, Britain's ReNeuron is about to start the world's first
stroke trial using foetal stem cells.
Also theoretically, any stem cell treatment filed with the EMEA to the
end of this year could become commercial in 2011.
The EMEA's scientific committee has instructions to issue an opinion
within 210 days of receiving an application.