First human embryonic stem cell trial approved

Washington: A US biotech company said today it will soon begin the first-ever European trials using human embryonic stem cells in an experimental treatment for people with a form of juvenile blindness.

The Massachusetts-based Advanced Cell Technology said thetrials will involve 12 patients with Stargardt`s disease and will be based at Moorfields Eye Hospital in London, with more European sites planned for the future.

"This is the first time an embryonic stem cell trial hasever been approved anywhere else in the world," said Bob Lanza, chief scientific officer at ACT and a longtime
researcher in human embryonic stem cells.

The clearance to begin the European trials came from theUK Medicines and Healthcare products Regulatory Agency and the Gene Therapy Advisory Committee, ACT said.

The same company became the first to launch a US trial ofembryonic stem cells to treat Stargardt`s disease in November 2010, followed in January by a second trial of the method in patients with dry age-related macular degeneration.

So far, only two US patients have been treated as part ofthose early trials which are mainly aimed at seeing if the treatment is safe before moving on to measure if or how well it works.

"We`re very pleased with the results so far. We`re in theprocess of scheduling the next two patients for each of the two (US) trials," Lanza said.

The use of human embryonic stem cells, which can becomeany cell in the body, has been touted by researchers as wielding great regenerative potential against a host of
disorders, from spinal cord injuries to Parkinson`s disease, blindness and diabetes.

However, the technology has raised objections by conservative and religious opponents who say it should be banned because the cells` extraction involves the destruction
of a human embryo.

Former president George W Bush had blocked governmentfunding for human embryonic stem cell research on new cell lines, citing religious grounds, a ban which President Barack Obama lifted in 2009.

A lengthy legal battle ensued, and in July a US federal judge finally dismissed a lawsuit that had temporarily blocked government funding for the research.

The move was hailed by the National Institutes of Health, which allocated about USD 40 million to human embryonic stem cell research in 2010 and has set aside USD 125 million this year -- a tiny fraction of its USD 31 billion budget.

Bureau Report