Death Revives Warnings About Rogue Stem Cell Clinics


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Death revives warnings about rogue stem cell clinics
22:00 17 June 2010 by Andy Coghlan
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The death of a woman after she was treated with stem cells at a private clinic in Thailand has reinforced warnings for desperate sick people to avoid "stem-cell tourism" ? the gamble of undergoing untested stem-cell treatments in unlicensed private clinics abroad.

Post-mortem results reported this week reveal that the stem-cell treatment almost certainly killed the woman, who had been suffering from kidney disease. She developed strange lumps in the kidney, liver and adrenal gland.

So what are the implications for stem cell research generally, and is it safe for clinical trials to continue? New Scientist has some answers.

What was wrong with the patient, and what treatment did she receive?

She had lupus nephritis, a condition in which the body's own immune system mistakenly attacks and destroys the kidneys. Usually it can be kept in check with immunosuppressive steroids, but when these failed, the woman turned to a private stem-cell clinic in Bangkok.

How would stem cells help?

Bona-fide trials in European clinics about six years ago showed that some people with similar kidney disease benefited if stem cells from their own bone marrow were injected into their blood. The body's immune system was first deliberately destroyed with powerful immunosuppressive drugs, then the reinjected stem cells helped to stop the attacks on the kidney by rebuilding and rebalancing the immune system. About a third of the 50 recipients relapsed after a year or so, and 12 of these people died. But around two-thirds saw benefits, with some going into remission.

So what happened with the woman who went to Bangkok?

Unlike the European trial patients, who'd had their stem cells injected into the bloodstream, the woman had her stem cells repeatedly injected directly into both her kidneys. The aim seems to have been to get the cells to repair the kidney directly, rather than retune the immune system.

And the result?

Three months after her treatment, her condition declined, and she went to the Chulanlongkorn University Hospital in Bangkok, where she received dialysis. Later, a kidney lump was identified in her left kidney; 11 months after her treatment, that kidney failed and she had it removed. Another year later, she died.

So what did examination of the kidney reveal?

At the injection sites, the woman had developed strange lumps and lesions, which turned out to be mixtures of bone-marrow and blood-vessel tissue. Similar lumps had also developed in the liver and one adrenal gland. A team led by Duangpen Thirabanjasak of Chulanlongkorn University Hospital report this week that the lumps almost certainly came from the injected stem cells.

Did the injected cells do any good at all?

No. Because they weren't circulating in the bloodstream, they couldn't rebalance the body's immune system to halt attacks on the kidney. One explanation for the strange lumps could be that the kidney was already heavily scarred and poorly supplied with oxygen. Injected into this oxygen "desert", the stem cells seem to have begun making new blood vessels to rebuild a new supply system for themselves. They were suspected to be benign, but no one knows whether they would have eventually turned cancerous.

Is the case a one-off?

Susan Quaggin of the Mount Sinai Hospital in Toronto, Canada, and co-author of a commentary on the results in Journal of the American Society of Nephrology, says that treatment by direct injection of stem cells into the kidney is highly unlikely to be contemplated or undertaken in bona-fide scientific trials. "There's no scientific rationale for doing it that way," she says.

So no need to panic then, and halt all stem-cell trials?

Absolutely not, according to Quaggin. All bona-fide trials must receive ethical approval beforehand and are scrupulously monitored, and the results must be peer-reviewed for publication. But she says that the Thai results are yet another reminder that sick people should not gamble with their safety, and money, by turning to stem-cell tourism peddled by unscrupulous operators.

"The sad part is that many people are desperate, and what makes it even worse is that it costs lots of money," says Quaggin, who urges all prospective patients to access new advice on the internet by the International Society for Stem Cell Research, a body based in Deerfield, Illinois, which has also issued a set of guidelines for ethical stem-cell research.

What are other stem-cell researchers saying?

"It's a dreadful reminder reinforcing the absolute necessity for robust safety data in animal models before entering regulated clinical trials," says Chris Mason, director of regenerative medicine at University College London.

"For years we've been warning that this kind of thing was going to happen," says Robert Lanza, chief scientific officer at the stem-cell company Advanced Cell Technology in Worcester, Massachusetts. "I suspect this is just the tip of the iceberg: that there have been other dangerous side effects that haven't been diagnosed or reported to the scientific community."

Is the company that treated the woman now closed down?

The researchers don't know which clinic provided the therapy in 2006. But private clinics around the world have recently come under pressure. A clinic run by Cell Medicine in Costa Rica was recently closed by the Costa Rican health ministry. And last year, Chinese authorities promised to clamp down on private clinics offering untested treatments in their country.

But the show must go on?

Indeed. The consensus seems to be that this is a timely warning of the dangers posed by unregulated clinics. But there's confidence that this was a somewhat freak result, and that most stem-cell treatments under trial are unlikely to pose such serious risks.

Journal reference: Journal of the American Society of Nephrology, DOI: 10.1681/asn.2009111156


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The ISSCR continues to use isolated cases like these to advance its own agenda. The last "poster patient" they harped on and on about was a child from the Ukraine that developed tumors after having some off the wall mixture that included fetal cells injected into his brain if I recall.

There are many reputable offshore clinics doing their own trials following the regulations imposed by their own health ministries. The U.S. has become bogged down in the usual research for profits, not patients, encouraged by the likes of Dr. Irv Weissman and others at the ISSCR. Research pays big bucks. Cures don't! I have challenged this group before and told them to find me a stem based trial for COPD in the U.S. and I will be packing my bags. There has been no response to my challenge yet.

In the meantime, offshore clinics that follow the ICMS safe guidelines have improved my life and stopped the progression of my disease which is something not offered in the U.S. And we certainly can't forget the billions of dollars at stake if Big Pharma can't drug us all from cradle to grave. Make no doubt about it, a cure is not the goal of the ISSCR or Big Pharma, 2 groups that rely on each other to do whatever it takes to keep us from getting stem cell therapy.


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ISSCR - Where are you?

Arthritis Drug Now Linked to Fatal Liver Failure
Health Sciences Institute
July 16, 2010

Popular rheumatoid arthritis drug Arava just got a new black-box warning: It may just kill you.

Turns out that this FDA-approved killer drug has been putting people at risk for eight years! In fact, 14 people suffered fatal liver failure between August 2002 and May 2009 (and who knows how many since).

And that's just the people who died--there were also many cases of severe liver injury, bad enough to require hospitalization.

Bottom line: If you take Arava for your RA symptoms, talk to your doctor about getting off this dangerous drug.


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A doctor's reply to the infamous Kidney Case

Causation has a set methodology that must be followed. If we use modified Hill and Miller criteria, this is what would be needed:

-Temporal association
-Lack of likely alternative explanations
-Biologic plausibility

Before we plug the data into these categories, let's start with basics. Thirabanjasak et al failed to document a steep and sudden progression of ESRD after the stem cell therapy. In renal disease this is very easily accomplished via serum creatinine (a common blood test on every chem panel run in a clinic or hospital). This is directly correlated to renal function, so for example a patient that has a creatinine that starts at a 2.0 and ends at a 4.0, has lost 50% of their renal function. In this case, what would have been required to draw the connection between the therapy and the therapy would be a several year history that looked like:

After stem cell treatment-4.6

Without that, there's no way to draw a direct connection, since removing one of two semi-functioning kidneys (what happened here when they believed there was neoplasia and obviously with good reasoning at the time) would be a logical explanation of why she went on dialysis. If that data is available, it should have been published. Even then, obviously multiple blind passes with a needle through the kidney could have caused damage to the kidney as well. However at least the case would have been strong that some part of the procedure cased a sudden drop in renal function before they removed the kidney.

One could argue that if she never went for the therapy in the first place none of this would have happened, but this also brings up weaknesses in the Thirabanjasak et al paper, as the motivation for the stem cell therapy was never revealed. If she sought the treatment to avoid the foregone conclusion (reached by her physicians) that she would soon need dialysis, then the outcome with or without the therapy may have been identical (since she died of the infected AV shunt, a common complication of dialysis). If she sought it simply because she had mild disease and was tired of conservative oral therapy, then the argument would be stronger that the stem cell therapy eventually lead to the event that killed her.

So if we plug in the data as presented for cause of death (need for dialysis):

-Temporal association-check, but poorly documented (as above)
-Lack of likely alternative explanations-as above, removal of the kidney could have caused this need for dialysis, the patient may have been headed for certain dialysis anyway and was trying to avoid that fate
-Challenge/Re-challenge-This applies more to treatments or exposures that are serial, i.e. the condition worsens every time the patient was treated and remits when treatment is with-held. This may not apply here as I understand this was a single treatment.
-Biologic plausibility-See the creatinine discussion above. The key question being did these lesions cause decreased kidney function or could they have been left alone and monitored?

In summary there was no doubt this was bad medicine. I also have no doubt that Thirabanjasak et al did a great service to other nephrologists by reporting these lesions, so perhaps if this condition presents again, the next time the kidney won't need to be removed. However, regrettably they failed to meet the minimum scientific standards for causation as established by Hill, Miller, and others.