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Friday, May 14, 2010

EU agency prepares to assess first stem cell drug

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The first regenerative medicine based on stem cells could be filed for approval in Europe later this year, bringing the groundbreaking medical technology a step closer to reality.

The European Medicines Agency (EMEA) said on Wednesday it had been informed about the "intent of a European manufacturer to submit the first application for marketing authorization for a stem cell-based product."

Drugmakers typically send a letter of intent to the London-based watchdog four to six months before a formal application, a spokeswoman said, so this would imply a filing toward the end of 2010.

The EMEA declined to name the company involved.

In preparation for the first of a possible wave of applications, officials from the EMEA met this week with drug company officials, regulators from the United States and Japan, and academic scientists to discuss guidelines for approving such treatments.

Research into stem cells has increased dramatically in recent years and there are currently some 40 clinical trials underway in the European Union exploring the use of stem cells to regenerate lost or damaged tissues and tackle various cancers. The majority use adult mesenchymal stem cells.

Stem cells -- which are particularly flexible when taken from days-old embryos -- 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.

But their use is controversial and involves risk -- notably the danger that foreign cells might be rejected or could proliferate uncontrollably, leading to tumors.

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