Three people have been blinded after paying for a stem cell treatment that was promoted on a US government website as a clinical trial.
A report on the tragedy has been published in The New England Journal of Medicine, dated March 16.
Three elderly women signed up for the apparent trial – paying $5000 each for the privilege – thinking they were taking part in a study into the use of stem cells to cure macular degeneration.
The treatment involved the removal of fat tissue from each woman’s abdomen. The tissue was then processed with enzymes and the stem cells within it retrieved. A dense plasma was also isolated from each patient’s blood. The two materials were then combined and injected into their eyes.
Within a week the women began to experience a range of distressing symptoms, including vision loss, detached retinas and bleeding. All three went blind. Doctors believe there is very little chance that their sight can be restored.
The elderly women had all responded to an entry on the US government website ClinicalTrials.gov titled “Study to assess the safety and effects of cells injected intravitreal in dry macular degeneration”.
The procedure seems to have played on the hope that macular degeneration, a common form of sight loss among older people, could be arrested through the use of stem cell injections.
No evidence was presented to participants that such a procedure could work. Indeed, Thomas Albini, associate professor of clinical ophthalmology at the University of Miami, says there is no evidence that the kind of fat-derived stem cells used are at all capable of differentiating into retinal cells. ”
There’s a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous,” he adds.
Each of the women was asked to pay for the treatment – a fact, says Albini, that should have raised a red flag, because research trials are rarely if ever patient funded. The women were also not asked to sign consent forms.
It is possible, even likely, that the they gained a false sense of security because the study was listed on ClinicalTrials.gov, a widely used national register of clinical trials. The service is administered by the US National Institutes of Health.
Its presence on the register might reasonably be assumed to imply that the procedure and the study was in some way regulated and subject to oversight. However, because the process described did not require mandatory regulatory approval – as it would, for instance, if the stem cells or plasma were being transferred between subjects – it apparently escaped notice.
The cause of the women’s blindness is still being investigated. It might have been triggered by a specific response to the tissue transfer, or any of a number of potential procedural flaws.
There was a wide range of suspect practices involved in the so-called study, not the least being that the women were treated in both eyes at once, rather than one at a time. “There was a whole list of egregious things,” Albini says.
The study was listed on ClinicalTrials.gov as offered by a Florida-based public company called Bioheart. Since the listing, it has changed its name to US Stem Cell.
The company states that it is “committed to the development of effective cell technologies to treat a variety of diseases and injuries”. At press time it had not commented on the blinding of the three women.