"Regulation under attack": researchers concerned about unproven stem cell therapies

Leading stem cell experts have published a statement expressing serious concerns about unproven stem cell therapies. Their article, published on 3rd May in The EMBO Journal, sends a strong message to the Italian parliament, which is currently debating whether to change a recent law allowing the use of certain untested stem cell therapies in public hospitals. The group of 12 senior scientists and 1 legal expert argue that 'only rigorous science and rigorous regulation can ensure translation of science into effective therapies.'

 

The scientific community has been expressing strong concern about unproven stem cell therapies for some time. In this latest commentary, leading experts from Italy, Germany, the United Kingdom, The Netherlands and the United States explain why they are particularly alarmed by an impending legislative action in Italy, which they describe as 'unique and of global concern'. The law under discussion by the Italian government may allow routine administration of unproven stem cell therapies to patients in public hospitals.

The privately funded Stamina Foundation has been using cells they identify as mesenchymal stem cells to treat severely or terminally ill patients in Italy with a range of different diseases. The cells are grown and manipulated in the lab using procedures that have not been published or reviewed by the scientific community at large. The treatment is also proceeding without rigorous clinical trials to test safety or efficacy and in spite of a ban placed on the treatment by health authorities.

The Italian parliament will decide shortly whether they will proceed with controversial legislation passed in the Senate on 21 March that allows the unproven stem cell treatment developed by the Stamina Foundation to be used for severely or terminally ill new patients for 18 months. Hans Clevers, Professor of Molecular Genetics and President of the Royal Netherlands Academy of Arts and Sciences, commented:

“The adoption of this law may set a dangerous precedent for patients looking to be treated with other unproven stem cell therapies in Europe and other countries.”

Elena Cattaneo, Director of the Centre for Stem Cell Research at the University of Milan, Italy, and one of the scientists who contributed to the commentary article published in The EMBO Journal, explained:

“Irrational and unverified stem cell treatments based on methods that are not validated or scientifically documented should not reach patients. Preventing this from happening is a specific responsibility of health authorities and governments worldwide to make sure that the hope and trust of patients are not misused. Patients can be harmed and killed by medicines that have not been proven to be safe and effective via rigorously controlled clinical trials. The use of medicines that have not been manufactured to the highest possible standards is irresponsible.”

A system of well established steps - from laboratory resesarch to clinical trials - has been used successfully in the past to develop and introduce stem cell therapies such as bone marrow transplantation and treatments for repairing the skin and cornea. The authors of the commentary article emphasize 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. The regulations already in place in the European Union insist that stem cell therapies follow the same safety and efficacy rules as pharmaceuticals. The cells must be prepared and manufactured in highly controlled environments with precise protocols, trace-ability and accountability. The current debate in Italy could reclassify stem cell therapies as transplants in order to get around these existing EU-wide regulations. Paolo Bianco, Pathologist, Stem Cell Biologist, Professor of Pathology at the University of Roma, said:

“It is disconcerting that the Italian Senate has passed amendments that permit the use of unproven stem cell therapies without proper vigilance or proper experiment, reclassifying them as transplants. A host of proper and improper commercial interests might benefit from these new rules that abrogate both safety and proper ways of experimentation. Patients may be harmed."

Sean Morrison, Professor and Director of the Children’s Medical Center Research Institute at UT Southwestern Medical Center in the United States, who is not an author on the paper, added:

“Patients are ultimately not helped by therapies that are not based on sound science and that are not tested in systematic clinical trials. Efforts to water down regulation in this area may create opportunities for some individuals to prey on the hopes of desperate patients.”

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