Check it out!!!! We're not gonna far behind them!

http://news.yahoo.com/s/ap/20090123/...sci_stem_cells

Interesting comments re. the FDA, wonder if the new political climate will help "oil the wheels" for stem cells. Bush was certainly the sand in the cogs.

Neil.

http://www.ft.com/cms/s/0/df4d60c0-e...0779fd2ac.html

ReNeuron wins UK approval for stem cells trial

A dozen stroke patients in Scotland will be the first in the world to be treated with stem cells.

ReNeuron said UK regulators approved a clinical trial of its stroke treatment, which had failed to win approval from the US Food and Drug Administration.

Following the positive verdict of the UK Medicines and Healthcare Products Regulatory Agency (MHRA), shares in the Guildford-based biotechnology company rose by 174 per cent to close at 7.88p.

Keith Muir, a neurologist at Glasgow University, will lead the trial at the city's Southern General Hospital. He expects to start this summer injecting ReNeuron's "neural stem cells" into the brains of patients who have been left disabled by a stroke.

Animal tests suggest that the stem cells - derived from a cell line that originated several years ago from an aborted human foetus - will help the patient's brain to regenerate, reversing some of the damage caused by the stroke.

John Sinden, ReNeuron chief scientist, said the company had sounded out the MHRA and other European regulators in 2005 about a clinical trial of its stroke therapy and had received an unenthusiastic response. So it went to the US instead.

But ReNeuron's initial optimism evaporated as the FDA consistently refused to approve the trial. "We felt that we could never satisfy them," Dr Sinden said.

When the company returned to the MHRA last year, its attitude was different. "We had a very positive reception," he said.

He added that if those attitudes continued "the UK rather than the US could become the place to carry out stem cell trials of a more difficult nature". But the FDA's stance could change with today's presidential inauguration of Barack Obama, who is more supportive of stem cell research than George W. Bush.

A number of drug companies have accused the FDA of being too risk averse, avoiding the authorisation of new tests and medicines. Its European counterpart has approved a number of trials and drugs more rapidly, including a new procedure allowing biological generic medicines for the first time.

Since 2006, when life-threatening side-effects emerged during tests on six volunteers at Northwick Park Hospital in London, European regulators, including the UK's MHRA, have established a series of special advisory groups to scrutinise high risk trials, including those involving stem cells. They have been keen to ensure appropriate safeguards while maintaining clinical research.

Regulatory delays have left ReNeuron with serious funding problems. But Sir Chris Evans, the biotech entrepreneur whose Excalibur investment group owns almost 30 per cent of ReNeuron, told the FT yesterday: "We have put a funding line in place that will take the company through at least to next year."

Sir Chris said the plan was to raise a substantial amount of money later in 2009 that would fund more extended clinical trials.

YES, At last!
Geron seemed ready for stem cell therapy for various diseases including PD two years ago, but had to wait till now. I was at a meeting couple of years ago, where Geron;s CEO showed impressive results with spinalcord injury models. They had partial success with PD in monkeys. Stem cells helped monkeys with PD but not for long. It seemed like neuronal cell death was still a problem. That was 2 years ago. Hope they have better data now.

girija




're not gonna far behind them!

http://news.yahoo.com/s/ap/20090123/...sci_stem_cells[/QUOTE]

http://www.sunderlandecho.com/news/D...-of.4910642.jp

Durham boffins on brink of stem cell breakthrough

North East scientists claim they are on the brink of a breakthrough in the use of new stem cell technology to repair damaged brain cells.
Experts at Durham University have worked for five years on the pioneering process which could be used to treat diseases such as Alzheimer's and cancer or to help stroke victims.

The work involves the creation of nerve cells which can then be used
to repair damaged parts of the body.

Dr Stefan Przyborski said the university was at the forefront of the development of such technology.

As well as playing a key role in the fight against some of the more common and debilitating diseases, the technology could also provide a boost for the North East economy.

The region has become world renowned for its work in the sector and many new businesses have emerged to support the research that is underway.

Pharmaceutical companies are keen to use the technology to test new drugs, making the research potentially very profitable.

The work could bring any number of benefits, say scientists behind the research being carried out in Durham.

Dr Przyborski said: "When someone suffers a stroke or from Parkinson's disease their brain cells die. The question is how do you get them to grow back?

"We have developed technology whereby stem cells can be stimulated to become nerve cells. Consequently these nerve cells could be used to develop new drugs to treat such diseases, or ultimately to replace the damaged tissue."

His colleague, Dr Todd Marder, said: "We are at the forefront of development – what we have produced is more robust than anything else around.

"We use the most modern methods in the world to make the chemical compounds which cause the stem cells to transform.

"It can not only benefit the North East economy, but more importantly it could be an important step towards delivering on the promise of stem cell technology.

"This is a long term project. We have been at it for five years now and we have made tremendous progress. We are now ready to start marketing our first products."

Did anyone hear about the stem cells treatment in china in "stemcellspuhua"
Puhua hospital?

Thanks,
Rami

According to December's DDN (Drug Discovery news), Pfizer is "going regenerative", as a result of expected changes in stem cell policies by the new administration. This is wonderful news. The major pharma companies are finally waking up to the fact that regenerative medicine will be the mantra of 21st century medicine, just as small molecule discovery was to the 20th century. Hold on PWP, a cell based "cure" for PD is only a few years away. I don't expect every one of us to be able to be 100% functional, shortly after their transplant, but i do expect our quality of life to go way up to what it is now. cs

as girija said, Geron were ready years ago, ReNeuron first applied to trial in 2005 !! So much wasted time due to political dogma.

Good luck to us all.

Neil.