The Italian Senate has approved an 18-month, €3 million clinical trial of a controversial stem cell-based therapy. The vote, on 22 May 2013, will also allow a hospital to continue to treat patients already undergoing the contested treatment - although new patients may not be enrolled.
Developed by Davide Vannoni, a psychologist at the University of Udine and president of the Stamina Foundation in Turin, this therapy uses patients' own mesenchymal stem cells, derived from bone marrow, to treat neurodegenerative conditions such as Parkinson's, Alzheimer's, and amyotrophic lateral sclerosis, as well as muscle-wasting disorders. The Italian Medicines Agency (IMA) closed Vannoni's clinic in Brescia, where Stamina was treating up to twelve patients, in 2012 after a site visit.
Some of the patients receiving treatment and their families then sought legal exemption under compassionate use. Under Italian law, unapproved therapies are allowed on the grounds of compassion in exceptional cases for patients suffering from severe, incurable conditions only as a last resort. However, the therapy in question must meet Italian quality control standards, and there must be published data recognising its safety and efficacy.
As Professor Amedeo Santosuosso, a Milanese judge, and president of the European Centre for Law, Science and New Technologies, University of Pavia states: 'In the case of the Stamina Foundation therapy, there is no suggestion that it might be efficacious, so in my opinion compassionate use is not legitimate'.
Both within Italy and throughout the international community scientists have expressed serious concern over the efficacy of this treatment. The International Society for Stem Cell Research has issued a statement, saying: 'It is not clear based on the scientific literature that mesenchymal stem cells have any ability to ameliorate neurological conditions nor is there compelling evidence from clinical trials that such cells provide benefit to patients with neurological conditions'.
The final version of the law significantly amends the original decree, which was proposed in March amid protests from patient groups and pro-Stamina supporters after the treatment was halted by the IMA. The initial version, proposed by then-health minister Renato Balduzz, would have allowed thousands of patients to join the trail but was met with widespread disapproval from the scientific community. It would have also likely fallen outside the European Union's regulation of such therapies, says Science Insider.
Some see this episode as symptomatic of the lack of steady support for stem cell research in Italy. Massimo Dominici, a cell biologist at the University of Modena, claims that the clinical trial is '…a waste of money'. He states that 'if the Government would provide enough research funding, we could translate research into [therapies] under scientific rules, rather than this way'.
Vannoni has said the Stamina Foundation will not be able to provide the treatment according to good manufacturing practice. He explained the treatment is not able to be prepared according to international standards as the composition of the culture medium varies every two days.