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Thursday, November 17, 2011

 Geron halts pioneering stem cell research

The dream of using stem cells to treat people paralysed by spinal injury has been dealt a major blow. Biotech giant Geron has called a halt to its entire stem cell programme, the largest of its kind in the world. That includes a trial to treat 11 people with spinal injuries, which began a year ago.

"Geron is a pioneer and it is very disappointing that the company has had to change direction. The public will need reassurance that this is not the end of an era," says Dusko Ilic of King's College London.

The firm based in Menlo Park, California, says its decision is purely financial and not based on moral reasons or negative results from the four paralysed patients treated so far . The company will now focus all its resources on developing anti-cancer drugs.

The company had to choose between stem cells and cancer, and saw cancer as the better bet. "By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important [targets] without the necessity of raising additional capital," says John Scarlett, Geron's chief executive officer. "This would not be possible if we continue to fund the stem cell programmes at the current levels."

Controversial research

It took years and countless setbacks for Geron to win consent from the US Food and Drug Administration to begin the spinal trial. Geron's programme caused controversy because its cell lines come from human embryonic stem cells (hESCs) obtained through destruction of embryos. Anti-abortion and some evangelical groups have opposed the research because of this.

Most other treatments are based on adult stem cells but some based on hESCs are continuing, including a treatment for a form of blindness called Stargardt's macular dystrophy. "It leaves us holding the flag," says Robert Lanza at Advanced Cell Technology of Worcester, Massachusetts. "There's lots of pressure on us to deliver a success to keep the field alive, but of course it's the second mouse that often gets the cheese."

Too much, too soon?

Lanza questions whether Geron was wise to have chosen such a difficult condition as its first treatment. "Many experts were surprised when they selected spinal cord injury. We knew it was going to be very difficult to show a biological effect," he says.

Others agree: "Making superman walk would have been great for business, but was an ambitious target for a serious problem, and maybe not the best start scientifically or clinically for stem cell therapies," says Alison Murdoch at Newcastle University, UK.

"I have said publically that the Geron trial had no real chance of success because of the design and the [disorder] targeted," says John Martin, professor of cardiovascular medicine at University College London. "It was intrinsically flawed," says Martin, whose own trials are focussing on treating damaged hearts with adult stem cells.

Apart from cells for spinal injuries, Geron has also coaxed hESCs into cells for treating several other conditions, including heart disease, diabetes, arthritis and ligament damage.

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