WASHINGTON (Reuters) - Rogue clinics around the world may be exploiting hope and ignorance by offering unproven stem cell therapies, a group of stem cell experts said in a report released on Wednesday.
The International Society for Stem Cell Research released guidelines for researchers and regulators, and a guidebook for patients, that criticized some clinics.
“The International Society for Stem Cell Research is very concerned that stem cell therapies are being sold around the world before they have been proven safe and effective,” the guidelines said.
The group has declined to name any specific website or clinic but said they are widely advertised and reviewed in a study published in the journal Cell Stem Cell.
“The direct-to-consumer portrayal of stem cell medicine is optimistic and unsupported by published evidence,” Timothy Caulfield of the University of Alberta and colleagues wrote.
“The average cost of a course of therapy among the four websites that mentioned costs was $21,500, excluding travel and accommodation for patients and care givers. And examples of serious treatment side effects can be found.”
Stem cells are the body’s master cells and they come in a wide range of forms, from the cells in bone marrow that are widely used to treat cancer and other conditions, to embryonic stem cells -- those that give rise to all the cell types in the body.
The field has received intense attention, in part because it carries the promise of tailored treatments and truly regenerative medicine that might transform treatment of diseases such as Parkinson‘s, as well as catastrophic injuries.
It has also been sullied by scandal, notably the case of disgraced South Korean researcher Hwang Woo-suk, who admitted in 2006 to fabricating data to support claims he had made the first human embryos using cloning technology and then derived stem cells from them.
"Stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. Make sure you understand what to look out for before considering a stem cell therapy," advises the patient advisory, available here
For researchers and regulators, the group advises tough oversight and independent review.
The group, including Dr. Marina Cavazzana-Calvo of Hopital Necker-Enfants Malades in Paris, France, Dr. Giulio Cossu of Instituto San Raffaele in Italy and Dr. George Daley of Children’s Hospital Boston, urged governments and regulatory bodies to enact the recommendations.
“Regulators have a responsibility to prevent exploitation of patients in their jurisdictions, and where necessary, to close fraudulent clinics and take disciplinary action against the doctors involved,” Daley said in a statement.
Editing by Vicki Allen