European trials will commence and be pioneered by a US Biotech Company, after receiving the go signal to put on clinical trial an experimental treatment using human embryonic stem cells in people with juvenile form of blindness.
The clinical trials will be carried out by Advanced Cell Technology, a Massachusetts based biotech company. The trials will involve 12 patients with the Stargardt’s Disease and will be based in Moorfield’s Eye Hospital in London. According to Bob Lanza, chief scientific officer of the ACT, “This is the first time an embryonic stem cell trial has ever been approved anywhere else in the world.”
The green light has been given by the Medicine and Health Care Products Regulatory Agency and the Gene Therapy Advisory Committee. The said Massachusetts based company was also the first in the US to conduct clinical trials last November 2010 in patients with Stargardt’s Disease and was followed by another study among people with Dry Age-Related Macular Degeneration.
“We’re very pleased with the results so far. We’re in the process of scheduling the next two patients for each of the two (US) trials,” says Lanza.
According to many researchers, the use of human embryonic stem cells has a great regenerating potential among people with disorders of the spinal cord, Parkinson’s disease, diabetes and even blindness. But then, some pro-life groups oppose the said method of treatment because it is said to involve the extraction of stem cells by destroying the embryos.
On the basis of religious grounds and considerations, then President George W. Bush put a halt in the researches but was subsequently lifted by President Barrack Obama. The move was complemented by the National Institutes of Health, which allocated $40 million last 2010 and has set aside $125 million this year.
One major concern thrown at advocates of stem cell treatment is that these stem cells may develop into tumors. However, ACT said that there have been no studies to prove the same. Experimental tests on rats have shown 100% improvement in visual performance and near normal function, without any negative side effects, says the ACT team.
In the US and Europe, it is estimated that around 80,000 to 100,000 people will suffer from Stargardt’s Disease—one of the most common forms of juvenile blindness.
Once the clinical trials are proven to be successful, ACT believes it could extend to larger markets. Apart from the said disease, human embryonic stem cell treatment can also handle macular degeneration, and other degenerative diseases of the retina which affects 30 million people from the US and Europe.
In their dedicated information site for stem cell research, the National Institutes of Health said that Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth […] When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.