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02.04.2014

Unproven cell therapy from the Stamina Foundation in Italy now being re-evaluated

Leading stem-cell experts have raised concerns about unproven stem-cell therapies for some time. In 2013, the market approval of one such therapy, created by the Italian medical charity Stamina Foundation, led to extensive debate.

The market approval of this controversial procedure was first blocked by the Italian Medicine's Agency, AIFA, due to the above stated concerns. However, patients’ hopes were high, and some suspected the authorities of depriving them of something that could improve their quality of life or even be life-saving. Patients successfully lobbied the Italian government to allow the use of Stamina therapy in public hospitals.

The approval by the Italian government triggered a worldwide protest of leading stem-cell experts, who warned against laxness in therapy approval. One of the first and loudest against the market approval of stamina has been Professor Michele De Luca, a trained medical doctor, internationally recognised stem-cell biologist and senior EB researcher, based at the University of Modena.

In her statement below, Prof. Leena Bruckner-Tuderman, renowned EB researcher and Chair of DEBRA International’s Medical and Scientific Advisory Panel (MSAP), explains the great concern of the scientific community:

DEBRA International and leading EB researchers strongly support research into treatments for EB and other severe diseases but under the premise of it, without exception, being guided by the principles of scientific quality.

A system of well-established steps - from laboratory research to clinical trials - is used to develop therapies. Leading stem cell experts emphasise the importance of this process, stating that cell therapies must be approved by international and national regulatory agencies and remain under the strict vigilance of health authorities (see comments on the website of EuroStemCell, an organisation funded by the European Commission). The regulations already in place in the European Union require stem cell therapies to follow the same safety and efficacy rules as pharmaceuticals. The cells must be prepared and manufactured in highly controlled environments with precise protocols, traceability and accountability.

The strong reaction from the scientific community led to a re-evaluation of the therapy: The Italian Senate decided that the Stamina Foundation can no longer accept new patients for its unproven procedure, which is now to be evaluated in a 3 million Euro clinical trial funded by the Italian government.

There are a number of research groups worldwide investigating into the therapeutic potential of stem cells, some in the field of EB and supported by DEBRA International. We have funded preclinical EB stem-cell research (e.g. Prof. Mitchell Cairo, New York Medical College; Dr. Olga Igoucheva, Jefferson Medical College) as well as early-stage clinical trials (e.g. Dr. Jakub Tolar, University of Minnesota; Prof. John McGrath, King’s College London). These projects have all undergone scientific peer-review and are generating some promising results. Still, they are yet some steps away from the clinic.

From the patient’s view, research and therapy development always seem to be progressing too slowly but it is important that people eager for better treatments or cures are not misled by those offering the quick and easy way. Making sure a treatment not only works but is also safe will take its time.

Read more on the website of EuroStemCell:

Barbara Dissauer, DEBRA Austria and DEBRA International

Chalkboard with "Stamina?" written on it