Friday, August 24, 2007

Stem-cell therapy: Cure or hoax in China?

'Some get miracles'; others are skeptical

The website for Beike Biotechnology bursts with stories that can only be categorized as medical miracles: a paraplegic can move his legs again; a man with muscular dystrophy can carry a cup of water, a stroke victim can speak.

These tales of ailments treated come from all over the world - England, Hungary, Russia, Canada - and back the healing claims of a controversial Chinese treatment that purports to cure the incurable.

"I saw miracles every day I was there," says Leslie Wells, who flew to China in April, 11 years after a swimming pool accident rendered her arms and legs limp. "It can be a crapshoot. Some people get miracles, some people get nothing."

Doctors at Beike - based in Shenzhen, China - are treating a host of nerve disorders with stem-cell therapy, a procedure still under early clinical trials in much of the Western world. In just two years, doctors at Beike have injected stem cells from umbilical cords into the spines of nearly 1,000 patients from outside the country. Roughly 30 of those patients came from Canada, according to a Beike spokeswoman.

Approval for such treatments in Canada is years away, and the medical community here stands firmly opposed to people seeking them in China, citing possible health risks. In a research paper published in Neurorehabilitation and Neural Repair last year, several doctors in Canada and the United States followed up with patients of Hongyun Huang, who has been offering stem-cell treatments in China for several years. Few of the patients had improved since returning from China.

"If it sounds too good to be true, it's too good to be true," says Michael Rudnicki, Canada Research chair in molecular genetics at the University of Ottawa.

But increasing numbers of Canadians are sidestepping domestic regulations and venturing to China in hopes of a cure.

Ms. Wells, of Milton, Ont., first heard about Beike in a news story she read about two Ontario women who had suffered spinal-cord injuries in a car accident and then received the stem-cell treatments in China with some success.

As she flipped through the beaming testimonials on the company's website, it crossed her mind that the whole thing might be a scam. She just wanted a cure to nerve pain so crippling that "no painkiller known to man would help."

Her spine specialists warned her against it.

Eventually, she decided. "I was like, all right, what do I have to lose? Just a little money."

Ms. Wells paid $23,000 for the procedure and travelled to Nanshan Hospital in China, where she received six injections teeming with stem cells into her spinal fluid. Beike says the stem cells repair damaged nerves.

After her second injection, the pain that had made jobs and school seem impossible, was nearly gone.

"On a scale of one to 10, it went from like a nine down to a two. I haven't taken a single painkiller since."

She's not alone in her praise of the injections. With his speech and balance failing, George Arruda, an Ancaster, Ont., landscaper with ataxia, flew to Nanshan for four spine injections and two IV drips.

Ataxia is a progressive disorder that prematurely kills the nerve cells responsible for balance and co-ordination, and is one of the long list of neural conditions that Beike will treat. That list also includes epilepsy, ALS, cerebral palsy, spinal-cord injury and strokes,

Mr. Arruda knew it was an uncertain therapy, but his wife had recently given birth to a daughter. "I just wanted to be a healthy strong dad for her."

Before the trip, he could get around only with the aid of a walker. One night, about midway through his treatment, he was surprised to find himself walking to the bathroom unassisted.

"Immediately, I was about 20 per cent better," he says.

Since returning to Canada in February, he's had a relapse of symptoms. But he says that was probable considering the degenerative nature of ataxia. He's now looking at other stem-cell treatments.

Western medical experts chalk up the positive testimonials to the placebo effect. "We can give people a sugar pill and tell them it will get rid of all their pain and they'll insist that it works," Dr. Rudnicki says, "so I'm highly doubtful of testimonials. If I just spent $30,000 on a procedure, I would want to say it worked too."

Researchers at the University of Alberta are in the midst of studying the proliferating number of companies offering stem-cell cures. So far, they've discovered more than 30 based all over the world.

"The term stem cell has so much currency around the world right now," says Tim Caulfield, Canada Research chair in health law at the University of Alberta and member of a Canadian network of stem-cell researchers. "Even though the scientific community is deeply skeptical, people just associate the term with hope. It's a perfect area for quackery."

Eventually, Dr. Caulfield expects that researchers can use the University of Alberta study to make policy recommendations. "If there is fraud, we want to find it. The people going in for this are often tremendously sick and desperate. We want to ensure they are not being exploited."

Beike is open to the scrutiny. Patients are encouraged to post pictures and blog entries online documenting their time in China. Most depict a pristine hospital with cheery medical staff.

"Most of the doctors who work for us have been trained in Europe or the U.S.," says Kirshner Ross-Vaden, lead medical consultant with Beike's North American operations. "These are people who are leading the entire medical field. We have the nicest hospitals in China. The North American medical establishment is simply behind the times."

Beike says that 86 per cent of their clients show some measure of improvement.

Researchers in Canada say that while clinical trials have begun to look at the possibilities of stem-cell treatments, the therapies won't be available to the public for years - if they actually work.

Until that day comes, researchers here continue to advise against a stem-cell trip to China.

"They are ... putting patients at risk," Dr. Rudnicki says.


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Monday, August 20, 2007

"Spinal Cord Injuries" on Patient Power with Andrew Schorr

The radio and internet program, "Patient Power with Andrew Schorr" will feature an upcoming program entitled, "Spinal Cord Injuries," featuring a medical expert in the field, David Chen, MD. It airs live online at HealthNet on August 28, 7 p.m. Central Time, and listeners may call in with questions, or send questions via e-mail.

Replays and transcripts will also be available on Patient Power following the live show.


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Friday, August 10, 2007

Stem Cell Scientist Sets Record Straight on Spinal Cord Injury Trials

There's been lots of confusion and some mischaracterizations about when the first embryonic stem cell clinical trial might take place and what it might treat. Spinal cord injury has been a leading candidate. Hans Keirstead, a scientist at the University of California at Irvine has been at the center of the discussions. His work, which has helped rats with severed spinal cords "walk" again, is funded by Geron, a biotech company in Northern California. Geron executives have adjusted their timeline for trials several times, which is perhaps understandable but has led to some of the confusion.

Keirstead has addressed a spinal cord injury message board to clear things up. He's got three projects in the works, the first of which does not use stem cells at all (it's an antibody, thanks Steven!) The second will use embryonic stem cells to treat acute (i.e. recent) spinal cord injures. The third and newest effort addresses chronic spinal cord injuries.

Read Keirsteads full post from CareCure after the jump. Not to get sappy or anything, but that last paragraph makes me want to, I don't know, have brunch with him.

In response to a recent news misquote and queries over the last year, I would like to clarify my views on the timeline to the clinic for the treatments being developed by my research team.

It would be foolish and misleading to say that one will cure or ‘fix’ someone with a spinal cord injury in a given period of time. I hope that through perseverance and a lot of hard work our research developments will benefit people’s lives, but I have no orb with which to predict the future.

What I do know is this: the treatments that we are developing improve the outcome of spinal cord injury in rats but do not completely cure them. We do not know if these approaches will work in humans until we test them in humans. Importantly, the U.S. Food and Drug Administration (FDA), informed by clinical trial results, will ultimately determine if and when a treatment becomes available to the public.

The first potential treatment that my research team has developed is an injection-based therapy intended for acute spinal cord injury, meaning that it would be administered within hours of the injury. The treatment significantly decreases spinal cord loss when administered within this narrow time frame. After developing the treatment, our team and others showed that it improved the outcome of rodent models of spinal cord injury, multiple sclerosis, rheumatoid arthritis and ulcerative colitis. In 2006, Medarex Corporation began a clinical trial evaluation of this approach in patients with ulcerative colitis. We are overjoyed to see this treatment being tested in humans, and hope to see the treatment used ‘off-label’ in spinal cord-injured people should the ulcerative colitis trials prove successful.

The second potential treatment that my research team has developed is intended for sub-acute spinal cord injury, to be administered within weeks of the injury. This treatment is a human embryonic stem cell-based therapy that re-insulates the electrical conduits of the spinal cord that lost their insulation following injury. Our research team has shown that this treatment bettered the outcome of rodent models of spinal cord injury and is safe. Further safety tests are now being conducted, and Geron Corporation is planning a clinical trial using this approach in 2008. They deserve our support for their pioneering and heroic efforts to get the first FDA-approved human embryonic stem cell-based treatment to the clinic.

The third potential treatment that my research team is developing is intended for chronic spinal cord injury. Ideally, this therapy could be administered months, years or decades after an injury, and understandably is a research direction that has created great excitement among the spinal cord injury community. However, it is important for people to understand that we have only just begun this endeavor. We have not yet even determined whether the tools that we have developed work in animal models or are safe. The outcome of these early studies will determine if and when this therapeutic approach will move forward to further animal testing and, ultimately, clinical evaluation.

I promise that my research team will push towards the goal of treating spinal cord injured people with intellectual rigor and tremendous personal intensity. We understand that our job is to invent safe and effective treatments that may then be evaluated in the clinic. I expect that we will fail and succeed along the way, and thank you in advance for allowing us to do both.

By Kristen Philipkoski
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