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 Modern genetic sequencing tools give clearer picture of how corals are related
17.08.2017 | University of Washington

nachricht The irresistible fragrance of dying vinegar flies
16.08.2017 | Max-Planck-Institut für chemische Ökologie

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

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

Im Focus: Fizzy soda water could be key to clean manufacture of flat wonder material: Graphene

Whether you call it effervescent, fizzy, or sparkling, carbonated water is making a comeback as a beverage. Aside from quenching thirst, researchers at the University of Illinois at Urbana-Champaign have discovered a new use for these "bubbly" concoctions that will have major impact on the manufacturer of the world's thinnest, flattest, and one most useful materials -- graphene.

As graphene's popularity grows as an advanced "wonder" material, the speed and quality at which it can be manufactured will be paramount. With that in mind,...

Im Focus: Exotic quantum states made from light: Physicists create optical “wells” for a super-photon

Physicists at the University of Bonn have managed to create optical hollows and more complex patterns into which the light of a Bose-Einstein condensate flows. The creation of such highly low-loss structures for light is a prerequisite for complex light circuits, such as for quantum information processing for a new generation of computers. The researchers are now presenting their results in the journal Nature Photonics.

Light particles (photons) occur as tiny, indivisible portions. Many thousands of these light portions can be merged to form a single super-photon if they are...

Im Focus: Circular RNA linked to brain function

For the first time, scientists have shown that circular RNA is linked to brain function. When a RNA molecule called Cdr1as was deleted from the genome of mice, the animals had problems filtering out unnecessary information – like patients suffering from neuropsychiatric disorders.

While hundreds of circular RNAs (circRNAs) are abundant in mammalian brains, one big question has remained unanswered: What are they actually good for? In the...

Im Focus: RAVAN CubeSat measures Earth's outgoing energy

An experimental small satellite has successfully collected and delivered data on a key measurement for predicting changes in Earth's climate.

The Radiometer Assessment using Vertically Aligned Nanotubes (RAVAN) CubeSat was launched into low-Earth orbit on Nov. 11, 2016, in order to test new...

Im Focus: Scientists shine new light on the “other high temperature superconductor”

A study led by scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg presents evidence of the coexistence of superconductivity and “charge-density-waves” in compounds of the poorly-studied family of bismuthates. This observation opens up new perspectives for a deeper understanding of the phenomenon of high-temperature superconductivity, a topic which is at the core of condensed matter research since more than 30 years. The paper by Nicoletti et al has been published in the PNAS.

Since the beginning of the 20th century, superconductivity had been observed in some metals at temperatures only a few degrees above the absolute zero (minus...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Call for Papers – ICNFT 2018, 5th International Conference on New Forming Technology

16.08.2017 | Event News

Sustainability is the business model of tomorrow

04.08.2017 | Event News

Clash of Realities 2017: Registration now open. International Conference at TH Köln

26.07.2017 | Event News

 
Latest News

Gold shines through properties of nano biosensors

17.08.2017 | Physics and Astronomy

Greenland ice flow likely to speed up: New data assert glaciers move over sediment, which gets more slippery as it gets wetter

17.08.2017 | Earth Sciences

Mars 2020 mission to use smart methods to seek signs of past life

17.08.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>