Six patients in California, USA, are suing a South Korean company and others for allegedly misleading them about the benefits of stem cell treatments sold to them.
The civil claim has been filed against stem cell company RNL Bio, alongside its Californian subsidiary Human Biostar, for the $75,000 the patients had spent on the treatments, plus punitive damages.
The group alleges that Human Biostar and its associates convinced them to travel to clinics in South Korea, China or Mexico to donate fat tissue from which stem cells were extracted and processed for therapeutic use. The patients claim they were told that stem cell treatments could cure their illnesses, which included diabetes, high blood pressure and insomnia, but they showed no signs of improvement. They also claim they were told the treatment could reverse the ageing process.
The patients have also questioned whether the stem cells were properly transported – they may have come from South Korea, through China, Los Angeles and Mexico before being injected.
This case highlights a growing area of concern amid allegations of fraud and safety concerns surrounding stem cell therapies. Dr Paul Knoepfler, associate professor at the University of California Davis Center for Neuroscience, explained there have been complaints about this kind of stem cell treatment for years - the US Food and Drug Administration and the Federal Bureau of Investigation have launched investigations into similar allegations - but this case is the first civil lawsuit for damages.
A decision in this case could have wide consequences for the stem cell industry; it may also add further to the debate surrounding different types of stem cell research and the US National Institutes of Health's guidelines for this.
Bernard Siegal, director of the Genetics Policy Institute, said 'any licensed clinician dabbling in stem cell therapies might face expensive lawyer's fees and economic ruin defending a civil claim for punitive damages that is not likely covered by standard medical malpractice insurance'.
The case could also have an impact on 'stem cell tourism', as international companies who currently operate within a regulatory grey area could be affected by a ruling if they were to market in the USA.
Siegal comments that 'the plaintiff's trial bar is well aware of the potential of this new lucrative speciality "cell therapy malpractice"'. Lawyers in the USA are already preparing for similar cases, and this decision may indicate whether we will see a new area of litigation.