Stem cell treatment which was conducted under clinical trial at an unnamed clinic in Florida has completely failed. Three women have received intravitreal injections of stem cells after which they had several complications and finally vision loss. Besides medical fail of the treatment, this clinical trial has a mark of unscientific and unproven research since it was patient funded. Even worse, two of the women thought they were participating in a government research project.
Wake-Up Call To The Relevant Institutions
Jeffrey Goldberg, chair of ophthalmology at the Stanford University and Thomas Albini, professor of clinical ophthalmology at the University of Miami published documents in wich they described problematic treatment. They denote their publication as a call to awareness for patients, physicians, and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research.
Three women in Florida, aged 72 to 88, have paid $5,000 to participate in a clinical trial to treat their macular degeneration. This condition is progressive eye disease which leads to blurred vision, retina damage and sometimes to total vision loss. However, it is more often that patients with AMD have troubles to recognize faces than to completely stay blind. Before the treatment, their vision ranged from 20/30 to 20/200. One week after receiving injections of stem cells, they suffered serious side effects: detached retinas, subconjunctival hemorrhage ( bleeding from the eyes) and finally blindness. Unfortunately, women probably will never regain their vision again. Adding the fact that women had to pay to participate in stem treatment is scandalous by itself, as it has never been the practice of major studies.
So, how could this happen? According to co-author Tomas Albini, 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.
What gave a legitimate coloring of this clinical trial was the fact that it was listed on Clinical Trials – a database of US National Library of Medicine. Although authors do not specify the name of the responsible clinic but provided the name of the trial ( Study to assess the safety and effects of cells injected intravitreally in dry macular ) wich clearly indicates who is behind the treatment – Bioheart Inc., also known as US Stem Cell.
This case is a good wake-up call for regulatory agencies to better check clinical trials as the lack of oversight can lead to serious consequences for patients.