EU OKs first embryonic stem cell trial
British health authorities have agreed to the first embryonic stem cell trial in Europe, which will target patients with a progressive form of blindness.
The UK’s Medicines and Healthcare products Regulatory Agency granted approval to using stem cells for treatment of a group of patients with Stargardt’s macular dystrophy, a major cause of blindness in young people.
The disease causes progressive vision loss through thinning the retinal pigment epithelial cells which are located at the centre of the retina, the light-sensitive tissue lining the inner surface of the eye.
The therapy includes injecting retinal pigment epithelial cells, or RPE cells grown from human embryonic stem cells. The injected cells will replace those that patients have lost through the process of their disease.
The Massachusetts-based company Advanced Cell Technology (ACT) announced on Thursday that a team of surgeons at Moorfields Eye Hospital in London will conduct operations on 12 patients with advanced stages of Stargardt’s disease.
The experimental treatment which got its first approval from the US Food and Drug Administration (FDA) last November will be tested in the UK alongside a similar trial that began in July at the Jules Stein Eye Institute at the University of California.
”This is another important milestone for ACT and for the field of regenerative medicine,” said ACT chairman and chief executive Gary Rabin.
During the European trial, led by retinal surgeon James Bainbridge, researchers inject between 50,000 and 200,000 stem cells behind the retina to replace defected and dead visual cells.
Bainbridge hopes that testing the safety of retinal cell transplantation pave the way for extensive use of the new technology for treating patients with Stargardt’s macular dystrophy.
”We are excited to start these trials in Europe, and look forward to analyzing the data we continue to collect in our ongoing trials to determine the engraftment and function of the transplanted RPE cells,” said ACT chief scientific officer Robert Lanza.
Source: presstv.ir