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Italy Orders Trials of Unproven Therapy

Italian lawmakers have demanded formal approval for a controversial stem-cell therapy, but allowed some patients to continue treatment under stricter rules.

Written byDan Cossins
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WIKIMEDIA, NISSIM BENVENISTYThe Italian Senate yesterday (May 22) passed a bill that allocates €3 million ($3.9 million) for clinical trials of an unproven stem-cell therapy that is already being used to treat a limited number of patients, reported ScienceInsider. The legislation also permits 12 patients to continue to receive the controversial treatment, which was developed by the Turin-based Stamina Foundation.

The bill was amended from its original version to state that Stamina cannot accept new patients, and that even the continuing therapies must be carried out under the supervision of government regulatory agencies and must use stem cells produced according to international quality standards, which Stamina has not previously adhered to.

Stamina claims that is has come up with a way to transform mesenchymal cells taken from a patient’s own bone marrow into new nerve cells that can be used treat a range of neurodegenerative diseases. But leading stem cell scientists have warned that there is no clinical data published in peer-reviewed publications to back up claims that the treatment is safe or effective.

Scientists are critical of the bill, which they argue has funded ...

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