Warning on stem cell tourism

Stemstem cells cell research is a powerful new area of medical science, with potential for treating a wide range of presently incurable diseases. Their potential has been acknowledged by the EU through its adopting the Advanced Therapies Regulation in 2007 and constituting a dedicated Scientific Committee at the European Medicines Agency, the CAT (Committee for Advanced Therapies), to assess advanced therapy products and improve access to them by patients. EURORDIS played a frontline role in promoting the adoption of this EU Regulation, intended to provide a better framework for the assessment of the quality, safety, efficacy of these treatments and their long term follow-up.

 

However, the expansion of ‘stem cell tourism’, meaning that patients travel to destinations where stem cell treatments with unproven benefits are provided, has raised serious concerns in the medical and regulatory environment.

 

“Seriously ill patients may be tempted to go to clinics which claim they can provide treatments which use stem cells to regenerate nervous tissue, repair brain damage, cardiac dysfunction, autoimmunity and other serious disorders,” argues Fabrizia Bignami, Therapeutic Development Director at EURORDIS and Member of the CAT. “Unfortunately, the current medical and scientific literature shows no proof for these sketchy claims.”

 

airportThese unauthorised ‘stem cell’ clinics offering ‘miraculous cures’ are often located outside of Europe and North America, in parts of the world where rigorous rules are not enforced. “Many desperate patients and their families decide to travel to these clinics after reading about them on the web,” argues Michele Lipucci di Paola, EURORDIS’ Patient Representative at the CAT. “The information they provide describes only the benefits and not the risks.”

 

This is why the CAT has recently issued a statement warning those who might be planning on using these unregulated treatments to think twice and to weigh the potential benefit against the tangible risks involved.

 

The Statement affirms that the development of experimental therapies by private clinics using ‘dubious’ stem cell preparations from a variety of sources, which are inadequately researched, could be detrimental to patients’ health. This is because outside controlled conditions, checks on the quality of these products may not have been carried out, and their safety and efficacy may not be accurately assessed.

 

“The fact that some patients have been asked to pay to participate in such experiments and that the results of these studies do not appear in peer-reviewed scientific journals, are clear indications that the therapies offered are not adhering to ethical, medical and scientific standards, which serve to ensure quality treatments and patient safety,” argues Fabrizia Bignami. ‘Moreover, accepting these treatments may be detrimental to well prepared ethically sound clinical trials by reducing an already small pool of eligible candidates. Most of the time, patients who undergo unauthorised treatments cannot be included in official clinical trials that could potentially lead to licensed therapies.’

 

LaboratoryThe CAT Statement indicates that to date, no stem-cell medicinal products have received market authorisation with the EU. It is still possible to gain access to stem-cell medicinal products under certain controlled conditions. These include taking part in clinical trials of compassionate-use programmes, or receiving a custom-made medicine as part of ‘hospital exemption.’

 

“The statement is not meant to hinder stem cell research and the development of advanced therapies, but to raise awareness amongst patients about the risks, and to increase their confidence that EU health regulatory authorities are working for a fast way to provide safe, effective and high quality stem cell treatment,” says Michele Lipucci di Paola. “Only continuous information on this topic by learned societies and training programmes will help reduce stem cell tourism which will be very difficult to avoid.”

 

Indeed, education of patients and health professionals is needed to counteract this growing phenomenon. The members of the CAT are particularly attentive to the patient’s perspective and they recognise that lack of information can jeopardise the enormous research potential in this area.

 

“This is the first time that a European Medicines Agency Committee has issued a warning of this kind. In the future, a scandal or a bad experience could create panic amongst the public and discourage funders from financing promising therapeutic leads,” explains Fabrizia Bignami. “This is another reason why it is imperative to warn desperate patients willing to take great risks, about the negative repercussions of their acts, on a germinal area of research which is at a delicate stage of its development.”

 

For more information:

Read the European Medicines Agency CAT Public Statement on Stem Cell Tourism

EURORDIS Contribution to an EU regulation on Advanced Therapies

The future EU regulation on advanced therapies (Mar 06)

Two EURORDIS’ representatives appointed to the Committee for Advanced Therapies at the European Medicines Agency (Apr 09)

EURORDIS’ Position Paper on Embryonic stem cell research and therapy (Nov 06)

 


This article was first published in the June 2010 issue of the EURORDIS newsletter.

 


Author: Paloma Tejada
Photo credits: © EURORDIS; rosettes: Inserm/ Benchoua; Alexandra; laboratory: Inserm/ Depardieu, Michel.

Page created: 20/01/2010
Page last updated: 02/07/2010
 
 
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