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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.

By | May 23, 2013

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 clinical trials on the basis of public opinion—after patient groups lobbied for the therapy to be given the green light—rather than any compelling scientific evidence.

Umberto Galderisi, a stem cell biologist at the University of Naples and president of Stem Cell Italy, told AFP that trials would “never have been allowed” if accepted scientific practice had been followed. “We do not want Italy to become one of those countries like China or Ukraine where there are untested scientific trials,” said Galderisi.

Davide Vannoni, a psychologist at the University of Udine and director of the Stamina Foundation, recently told ScienceInsider that in vitro and preclinical studies of the treatment had been published in Chinese scientific journals, but he did not provide copies of the papers.

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Avatar of: Ben F

Ben F

Posts: 8

May 27, 2013

Excellent to see that the Italy and America are allocating resources to and encouraging more research in regenerative medicine. http://online.wsj.com/article/PR-CO-20130515-915358.html

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