Cell therapy in Italy: who doesn't take risks...
In Italy, stem cell therapy was allowed without clinical trials
Stem cell treatment is provided to patients with various degenerative diseases by the Stem Cell Research Foundation Stamina Foundation at the Spedali Civili Public Hospital in Brescia. The therapy proposed by the foundation is based on the use of mesenchymal stem cells derived from bone marrow, which can become mature cells of bone and connective tissue.
The hospital agreed to become a base for StaminaFoundation research, including the isolation of bone marrow cells and the treatment of patients, in 2011, which immediately caused protests from the medical community. "The hospital has never even been among the 13 Italian organizations authorized to produce stem cells," says Michele de Luca, director and coordinator of the gene therapy program at the Center for Regenerative Medicine in Modena. After an inspection carried out in 2012 by the Italian Medicines Control Agency (AIFA), stem cell therapy with Stamina was immediately discontinued at the request of this regulatory body.
The agency's report noted that the Stamina Foundation does not follow the official prescriptions that are necessary to obtain permission for the clinical use of the method. In addition, there are still no scientific publications in which data on the effectiveness of the proposed therapy would be presented.
However, this ban caused protests in the patient community: family members of patients made assurances that "the treatment works." Some of them appealed to the courts, as a result of which several patients were able to continue therapy.
On March 14, a group of 13 Italian stem cell researchers published an open letter to the country's Minister of Health Renato Balduzzi, in which they requested the immediate termination of treatment conducted by the Stamina Foundation in a public hospital.
In response to this letter, Balduzzi signed a document last week authorizing the Stamina Foundation to continue treating those patients who have already started it, but only if there are no serious side effects.
Portal "Eternal youth" http://vechnayamolodost.ru01.04.2013