Italian health officials are allowing a handful of patients to continue with a controversial stem cell therapy amid protests from scientists that the treatments are unproven and unsafe.
The Stamina Foundation has been administering the therapy at the public hospital Spedali Civili of Brescia to people with a range of degenerative diseases. Their approach is based on mesenchymal stem cells, derived from bone marrow, which can become mature bone and connective tissue.
In 2011 the hospital agreed to host the research and assist with cell extraction and patient treatments, stirring protests from the medical community. "The hospital is not even listed among the 13 Italian authorised stem cell factories," says Michele de Luca, director and gene therapy programme coordinator at the Centre for Regenerative Medicine in Modena. After an inspection in 2012, Italian drug regulator AIFA ordered an immediate halt to Stamina's stem cell treatments at the hospital.
The AIFA report says the Stamina Foundation's treatment did not follow Italy's official path required for clinical approval. So far no scientific publications describing its effectiveness are available.
But the halt sparked protests among patients' families who believed the treatment was working. Some appealed to the courts, and as a result a few patients were allowed to go ahead with the therapy. On 15 March, a group of 13 Italian stem cell researchers published an open letter to the country's Minister of Health, Renato Balduzzi, asking him to shut down all of the Stamina Foundation's treatments at the hospital.
Instead Balduzzi signed a bill last week authorising the foundation to continue treatments in patients who had already begun the regime unless they are experiencing serious side effects.
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