Bogus stem cell trial sparks warning

researcher in the lab

The Macular Society is warning people not to be deceived by the health claims made by bogus stem cell clinics. It follows the news of three women who were left completely blind after undergoing unproven stem cell treatment in the US.

The patients aged from 72 to 88, all had macular degeneration and paid $5,000 (£4,100) each to undergo the procedure as part of what was claimed to be a clinical trial.

However, within a week of starting the therapy, which was described as "off-the-charts dangerous" by Thomas Albini, associate professor of clinical ophthalmology at the University of Miami, the patients suffered complications. These included further vision loss, detached retinas and bleeding. All three women are now totally blind.

A reputable medical journal, which reported the case, has prompted warnings of the risks to patients taking part in experimental stem cell therapy studies. 

Clinical trials in the UK are subject to strict laws, which are enforced by a number regulatory of bodies. The procedure in America failed to meet even the most basic requirements of a clinical trial and, according to stem cell experts, was not even founded on good science.

According to recent research more and more clinics are popping up across the US, marketing unapproved treatments for a variety of conditions. 

Cathy Yelf, chief executive of the Macular Society, said: "Stem cell research has the potential to bring great benefit to people with macular conditions and the Macular Society is funding some important work in this area. 

"However, it is vital that such research is fully controlled and we support the strict regulation which exists in the UK.

“There are no fully-trialled, approved stem cell therapies available yet for macular degeneration anywhere in the world, although early, ‘safety’ trials are showing promise.

“We know how desperate many people are to try to maintain their vision. We urge anyone who might be considering this sort of untested treatment to speak to their eye doctor first or call our helpline on 0300 3030 111.”  

In the UK several regulatory bodies are responsible for enforcing the legislation including the Human Fertilisation and Embryology Authority, the Human Tissue Authority and the Medicines and Healthcare products Regulatory Agency. The Gene Therapy Advisory Committee (GTAC) oversees the ethical conduct of stem cell and gene therapy clinical trials in the UK.

The Macular Society currently supports a number of projects which use stem cells to further our understanding of macular conditions and work towards new therapies. The Macular Society is a member of the Association of Medical Research Charities (AMRC) and more about the policy on the use of stem cells can be found at www.amrc.org.uk