Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Researchers outline concerns about unproven stem cell therapies

06.05.2013
An international group of leading stem cell researchers has issued a statement that specifies concerns about the development and use of unproven stem cell therapies.

The commentary is published online today in The EMBO Journal ahead of a debate in the Italian parliament on whether to change a recent law that allows certain untested stem cell therapies to be used by the public health system. The authors of the commentary argue that rigorous clinical testing and regulation of stem cell therapies are essential to introduce safe and effective medical interventions for patients.

“Stem cells may offer unprecedented opportunities to develop treatments for many diseases with unmet medical needs. This will take time. However, only rigorous science and responsible regulation can ensure the safe and effective translation of science into effective therapies,” remarked Paolo Bianco, Pathologist, Stem Cell Biologist, Professor of Pathology at the University of Roma "La Sapienza" and one of the 13 authors of the commentary who come from Italy, Germany, the United Kingdom, The Netherlands and the United States.

The concerns of the scientific community have been heightened by pending legislative action that may allow routine administration of unproven stem cell therapies to patients in Italy. Despite a lack of rigorous clinical trials to test safety or efficacy, a ban of the treatment by health authorities, and a lack of peer review by the scientific community, the privately funded Stamina Foundation has been using cultured mesenchymal stem cells that have been exposed to putative conditions that favour neuronal differentiation to treat different diseases in se-verely or terminally ill patients.

The Italian Chamber decides 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. “The adoption of this law may set a dan-gerous precedent for patients looking to be treated with other unproven stem cell therapies in Europe and other countries,” remarked Hans Clevers, Professor of Molecular Genetics and President of the Royal Netherlands Academy of Arts and Sciences.

“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,” remarked 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. “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.”

Preclinical and clinical tests have been used successfully in the past for the introduction of therapies for bone marrow transplantation and the regeneration of skin and cornea in patients. The authors of the commentary emphasize that cell therapies must be approved by international and national regulatory agencies and remain under the strict vigilance of health authorities. Regulations already in place in the European Union insist that stem cell therapies follow the same safe-ty and efficacy rules as pharmaceuticals. They need to be prepared and manufactured in highly controlled environments with precise protocols, traceability and accountability.

“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,” commented Bianco. “Infusions of mesenchymal stem cells are not transplants in any way. In Europe and the Unit-ed States, all kinds of cell preparations that are administered to patients follow-ing ex vivo culturing are classified as medicines, and monitored by drug agen-cies such as the US Food and Drug Administration, the European Medicines Agency and, in Italy, the Agenzia Italiana del Farmaco or AIFA. 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,” concluded Bianco.

Sean Morrison, Professor and Director of the Children’s Medical Center Re-search 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.”

The full statement from the scientific community is available online as follows:

Regulation of stem cell therapies under attack in Europe: For whom the bell tolls

Paolo Bianco, Roger Barker, Oliver Brüstle, Elena Cattaneo, Hans Clevers, George Q. Daley, Michele De Luca, Lawrence Goldstein, Olle Lindvall, Christine Mummery, Pamela Gehron Robey, Clara Sattler de Sousa e Brito, Austin Smith

Read the paper:

doi: 10.1038/emboj.2013.114

Further information on The EMBO Journal is available at http://www.nature.com/emboj

Media Contacts
Barry Whyte
Head | Public Relations and Communications
Tel: 49 6221 8891 108/111
barry.whyte@embo.org

Bernd Pulverer
Head | Scientific Publications
Tel: 49 6221 8891 501
bernd.pulverer@embojournal.org

About EMBO
EMBO is an organization of more than 1500 leading researchers that promotes excellence in the life sciences. The major goals of the organization are to support talented researchers at all stages of their careers, stimulate the exchange of scientific information, and help build a European research environment where scientists can achieve their best work.

EMBO helps young scientists to advance their research, promote their international reputations and ensure their mobility. Courses, workshops, conferences and scientific journals disseminate the latest research and offer training in techniques to maintain high standards of excellence in research practice. EMBO helps to shape science and research policy by seeking input and feedback from our community and by following closely the trends in science in Europe.

Yvonne Kaul | idw
Further information:
http://www.embo.org

More articles from Life Sciences:

nachricht The world's tiniest first responders
21.06.2018 | University of Southern California

nachricht A new toxin in Cholera bacteria discovered by scientists in Umeå
21.06.2018 | Schwedischer Forschungsrat - The Swedish Research Council

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Temperature-controlled fiber-optic light source with liquid core

In a recent publication in the renowned journal Optica, scientists of Leibniz-Institute of Photonic Technology (Leibniz IPHT) in Jena showed that they can accurately control the optical properties of liquid-core fiber lasers and therefore their spectral band width by temperature and pressure tuning.

Already last year, the researchers provided experimental proof of a new dynamic of hybrid solitons– temporally and spectrally stationary light waves resulting...

Im Focus: Overdosing on Calcium

Nano crystals impact stem cell fate during bone formation

Scientists from the University of Freiburg and the University of Basel identified a master regulator for bone regeneration. Prasad Shastri, Professor of...

Im Focus: AchemAsia 2019 will take place in Shanghai

Moving into its fourth decade, AchemAsia is setting out for new horizons: The International Expo and Innovation Forum for Sustainable Chemical Production will take place from 21-23 May 2019 in Shanghai, China. With an updated event profile, the eleventh edition focusses on topics that are especially relevant for the Chinese process industry, putting a strong emphasis on sustainability and innovation.

Founded in 1989 as a spin-off of ACHEMA to cater to the needs of China’s then developing industry, AchemAsia has since grown into a platform where the latest...

Im Focus: First real-time test of Li-Fi utilization for the industrial Internet of Things

The BMBF-funded OWICELLS project was successfully completed with a final presentation at the BMW plant in Munich. The presentation demonstrated a Li-Fi communication with a mobile robot, while the robot carried out usual production processes (welding, moving and testing parts) in a 5x5m² production cell. The robust, optical wireless transmission is based on spatial diversity; in other words, data is sent and received simultaneously by several LEDs and several photodiodes. The system can transmit data at more than 100 Mbit/s and five milliseconds latency.

Modern production technologies in the automobile industry must become more flexible in order to fulfil individual customer requirements.

Im Focus: Sharp images with flexible fibers

An international team of scientists has discovered a new way to transfer image information through multimodal fibers with almost no distortion - even if the fiber is bent. The results of the study, to which scientist from the Leibniz-Institute of Photonic Technology Jena (Leibniz IPHT) contributed, were published on 6thJune in the highly-cited journal Physical Review Letters.

Endoscopes allow doctors to see into a patient’s body like through a keyhole. Typically, the images are transmitted via a bundle of several hundreds of optical...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Munich conference on asteroid detection, tracking and defense

13.06.2018 | Event News

2nd International Baltic Earth Conference in Denmark: “The Baltic Sea region in Transition”

08.06.2018 | Event News

ISEKI_Food 2018: Conference with Holistic View of Food Production

05.06.2018 | Event News

 
Latest News

Better model of water under extreme conditions could aid understanding of Earth's mantle

21.06.2018 | Earth Sciences

What are the effects of coral reef marine protected areas?

21.06.2018 | Life Sciences

The Janus head of the South Asian monsoon

21.06.2018 | Earth Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>