Italian Government Heavily Criticized for Approving Untried Stem Cell Therapy

European scientists have assailed a decision that allows children in public hospitals in Italy to be treated using stem cell therapy, which is still in the experimental stage. The Italian Pharmacological Society was able to stop that treatment last May. However, bowing to pressures from parents who went to court to demand its continuance, the Italian government overruled the regulation last week and issued the decree on March 21. According to the Italian Health Ministry the decision was borne out of compassionate and ethical concerns because the children, some being terminally ill, have not shown any “grave collateral effects.”

Scientists in an uproar

Criticisms from several scientists were sent to Renato Balduzzi, the Health Minister. Generally they were commenting that the decision was based on emotions that were raised by the opinion of the public rather than due to scientific reasoning.

The unapproved stem cell therapy was created in the laboratory of Stamina Foundation, which is located in Italy. They therapy was allowed by the government to continue, unmindful of the police findings from their search conducted together with Italian Pharmacological Agency inspectors at the Stamina Foundation laboratory that prepares the stem cell treatments.

All work at the Stamina Foundation laboratory was ordered halted in May based on the findings. It was reported that the laboratory were “absolutely inadequate” and that the laboratory fail in the standards of maintenance and cleanliness expected of a laboratory that it would be difficult to ascertain if cell contamination is prevented.

The report also stated that the doctors that were administering the adult stem cell therapy were unaware of what they were giving the patients. Likewise, details of the therapies administered were not written on the medical records of their patients.

At the moment, what is known is that adult stem cells could be used to repair and maintain tissues in humans. However, removal of stem cells and administering them for patient treatment is still subject to lengthy research and testing because treatment benefits are yet unknown.

Court ruling

According to the decree issued by the Italian court, it covers all the patients that were already receiving the treatment acquired from the Stamina Foundations, patients that have started preparatory procedures and those that have been given a court order authorizing them to receive such treatment.

Dangers

Charles French-Constant from The Center for Regenerative Medicine of the University of Edinburgh said that there is still no scientific basis for these stem cell therapies that are still unproven, and these would only make the families of patients receiving the treatment poorer. There is no evidence right now that these treatments do not pose a danger to patients, and that it is likely to create a dangerous precedent, according to University of Modena’s Professor Michele de Luca. For scientists one of the dangers is that if someone dies from the untested treatment, it will create a huge obstacle in the advancement of all research on therapies using stem cells.

What are currently administered to the patients are adult stem cells that are introduced to the damaged tissues. Several therapies of this kind are in existence but all of them are still in different experimental stages.

Stem cells are the mother cells from the body. These cells are able to multiply and at the same time transform into any cell type. Stem cell research is still considered controversial since it involves stem cells from embryos, which are destroyed during extraction. Specialized cells could be produced from embryonic stem cells and scientists are working on harnessing their capability to produce any type of specialized cells that could be used for the treatment of several diseases including diabetes and Parkinson’s disease.