International experts are calling for global action on unproven and potentially dangerous stem cell therapies, and their misleading marketing to the public.
'Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk,' said Dr Sarah Chan from the University of Edinburgh. She is one of 15 authors who published the clarion call in the journal Science Translational Medicine.
Currently only few conditions can be successfully treated with stem cells, including blood cancers, some immune diseases, and severe burns.
Despite this, unlicensed clinics advertise stem cell-based treatments directly to patients promising a cure for various ailments when there is no evidence to show they will help, or that they will not cause harm.
The internet and social media have helped the burgeoning direct-to-consumer marketing of both licensed and unlicensed stem cell therapies, and 'offers sellers the ability to reach worldwide audiences, amplifying the difficulties of enforcing national laws in a global marketplace', note the authors.
They add that patients are vulnerable to these online marketing strategies due to the hyped media coverage of stem cell research; a lack of reliable information; and a combination of missing international guidelines and conflicting national regulations on procedures.
Foregoing alternative therapies, patients take risks on invalid stem cell-based procedures, which have led to deaths in Australia, Russia and Germany, warn the authors. While those who sell the treatments may be difficult to hold accountable due to legal grey areas on stem cell-based treatments in most countries.
In addition to the potential harm to patients, 'unfulfilled promises may bring regenerative medicine research and development into disrepute' the authors caution.
In their call for action, the experts from UK, the USA, Canada, Belgium, Italy and Japan urge for a cooperation of national and international efforts to control the global industry of stem cell-based medical procedures and their advertising.
The authors believe that 'predatory' clinics can be exposed on a national level, when scientific experts, investigative journalists and local authorities work together, such as in a recent trial of the Stamina Foundation in Italy, a highly publicized provider of unproven stem cell treatments (see BioNews 878).
They further suggest controls on advertising and international standards for the manufacture and testing of cell and tissue-based therapies, similar to global drug quality standards, which might be set by the World Health Organisation.
Such measures will only be effective when national governing bodies cooperate to ensure compliance, but the experts warn that 'the stakes are too high not to take a united stance'.