Thursday, February 19, 2009

Fetal Stem Cells Cause Tumors in Human Patient: Should Geron ESCR Human Trial License be Reconsidered?

This story is disturbing and raises questions about whether the FDA's license to Geron to conduct human embryonic stem cell experiments should be suspended pending further studies. In Israel, a child treated with fetal stem cells developed tumors four years after receiving fetal stem cell treatments. From the story:

The boy, now 17, received the stem cells in 2001 at a Moscow hospital and four years later scans showed brain and spinal tumours, PLoS Medicine reports. Israeli doctors removed the abnormal growth from his spine and tests suggest it sprouted from the stem cells...

The boy in question was treated for a condition called Ataxia Telangiectasia--a genetic disease that attacks the brain region controlling movement and speech. He received three courses of foetal stem cell injections to the brain and the fluid surrounding the spine. Four years after his first injection he was investigated for recurrent headaches and his doctors at the Sheba Medical Centre in Tel Aviv found two tumours--one in the spine and one in the brain at the same sites the injections had been given.

A year later, when the boy was 14, the doctors removed the non-cancerous tumour from his spine and it was found to contain cells that could not have arisen from the patient's own tissue and had in all probability grown from the donated stem cells. Although they were unable to sample the growth in the boy's brain, the scientists believe this probably arose from the injected stem cells too.

It is worth noting that this particular condition impairs the immune system. Nonetheless, a reason embryonic stem cells cause tumors in animal models is their hyper activity,which makes their proliferation hard to control. Adult stem cells don't seem to have this problem. Fetal stem cells are less "youthful"than embryonic, but more than adult, and thus this tumor finding raises renewed questions about using ES cells in humans at the present time--a worry expressed by supporters as well as opponents of ESCR:
They [commenting scientists] say the findings "do not imply that the research in stem cell therapeutics should be abandoned." Nonetheless, they say more work should be done to assess the safety of this therapy.
Which brings us to the Geron license from the FDA. Geron's work with its product has been exclusively with mice, which were not kept alive nearly the four years it took for this patient to develop stem cell-caused tumors. This raises a question of whether, in light of this report, the FDA should revisit its go ahead to Geron to use ES cell-derived cells in human beings,particularly since it might take years to learn whether the product causes tumors.

And while we are on the subject, it is important that the patient-subject consent forms that will be used in these experiments--which have not yet been made public--be carefully reviewed. The paralyzed patients who will participate in Geron's safety trials are full ambulatory at this moment. But these unknown persons will be seriously injured sometime soon. Within a week or two of their injuries, facing potential paralysis from spinal cord injury, they will be approached by Geron to be test subjects, since the product designed for acute cases, not people with long-term paralysis. This will be a very emotional time in which these patients will be in deep emotional distress at the prospect of never walking again. In such an urgent crisis situation, it will be particularly important that all participants be made unequivocally aware of the potential risks, that these adverse events might take years to develop, and indeed, that being the subjects of such potentially risky experiments, that they might have to be monitored for the rest of their lives. Or to put it more succinctly: the consent, when given, must be fully informed.

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21 Comments:

At February 19, 2009 , Blogger Bobby Bambino said...

So to clarify: The fetal stem cells that were injected into this boy were from a fetus who was NOT a clone of the boy, correct? I know that the "goal" of ESCR is to perfect SCNT and be able to harvest stem cells from a clone of the patient so that the patient will not reject the stem cells. Is that correct and what is the current status of being able to create a clone in order to be able to harvest the clone's stem cells? Thanks.

 
At February 19, 2009 , Blogger padraig said...

Since there are no proven & approved treatments involving fetal or embryonic stem cells, my first guess is that this is more of a medical fraud case than an indictment of stem cell research. There was some guy in Hawaii doing things like this to people living in his garage, for criminy sake.

 
At February 19, 2009 , Blogger Dark Swan said...

"Fetal stem cells are less "youthful"than embryonic, but more than adult, and thus this tumor finding raises renewed questions about using ES cells"

Exquisite cow manure artistry Wesley.

The cells in this study were differentiated neural progenitor cells, not Embryonic Stem Cells.

Neural Cells, like Adult stem cells, originate from ESCs by differentiation, so what does this "more youthful" BS mean? That is wrong. They are called Neural cells because they are already specialized to form Neurons!

By your logic any time there is an issue with any form of human cell research we should immediately halt hEmbryonic Research. Bogus!

If anything, this case is more akin to the Portugal butcher Lima who was taking olfactory mucosa cells and transplanting the raw mass into peoples spines with little success that was claimed by the ASCr zealots like Prentice. The warning should be that all these ASCr therapies you claim as successful therapies could actually be dangerous, but I never see you complaining about patient awareness for these treatments.

Could Gerons study cause problems like this? Sure, its possible it will, its possible it wont. There hasn't been enough research yet and yes patients need to be informed, which there is no evidence they haven't been informed.

So you suggest we halt human research because we havent enough human research??

Your non sequitur between a guy in Israel who has benign growth from neural cells to Geron's study is a gross stretch of the imagination.

Time and again you claim that your only speaking to the morality ESCr, time and again you contradict yourself by speaking to the success or failure of scientific results, and in this case your fabricating a scientific correlation to meet your pro-life agenda.

If anything this illustrates the fact that apoptosis need more study in all types of cells including ESCs, and that more research needs to be applied to resolve the issues of cellular growth.

 
At February 19, 2009 , Blogger Don Nelson said...

Fetal stem cells were all the rage years ago. People claiming to represent science waged the same war as some scientists said our morals were standing in the way and we were backwards anti-science people who didn't care about others just as the pro-ESCR people have been doing for the last several years.

 
At February 19, 2009 , Blogger Lydia McGrew said...

Bobby Bambino, to answer your question, there has been no success AFAIK in making human clones for spare parts. However, the tissue rejection issue and the tumor issue are separate. Even a clone's embryonic stem cells would carry tumor danger because of their early stage. Embryonic stem cells are just very hard to control and do have a tendency to go tumorous. I wish to point out that ANT cells would presumably have the same problem. I don't know whether there is reason to think that iPSCs would be better on this front or about the same.

 
At February 19, 2009 , Blogger Bobby Bambino said...

OK great, thanks Lydia. It seems to me that ANT also has the additional problem of needing many oocytes. That seems to open a whole can of worms trying to obtain them. Then there is the additional problem of "proving" that the fusion does not result in a human. I don't have much faith in ANT, though it is a very praiseworthy idea.

BTW, Lydia, I graduated from WMU in 2005 in math, and I knew who your husband was and saw him give a math talk. Nice to "meet" you.

 
At February 19, 2009 , Blogger bmmg39 said...

"If anything, this case is more akin to the Portugal butcher Lima who was taking olfactory mucosa cells and transplanting the raw mass into peoples spines..."

-- except, of course, that Lima actually did some good for his patients...

"The warning should be that all these ASCr therapies you claim as successful therapies could actually be dangerous, but I never see you complaining about patient awareness for these treatments."

Wrong AGAIN. (Wow.) WJS has more than once warned against hype, including for ethical research on adult stem cells. There are opportunists out there who will profit on hype and overinflate hopes, regardless of what kind of cells they contend they are using...

 
At February 19, 2009 , Blogger victor said...

"IT" really is scary! I know that there are doctors out there who truly care about people and then there are others who are probably more interested in playing gods with the wild side of life.

How much longer Lord before YOU show U.S. what we're doing wrong and/or where do we draw the line?

God Bless all His Children's Cells

Peace

 
At February 19, 2009 , Blogger Lydia McGrew said...

Hey, Bobby, that's cool!

I've got to look up this Portugal case. I think I just heard some hype about that the other day. I'd assumed it was talking about iPSC's but now I'm thinking I was wrong.

 
At February 19, 2009 , Blogger Don Nelson said...

Bmmg39. Good stuff. SHS has been warning pro-life advocates not to hype successes and make the same ridiculous claims like the MO and CA advocates were making or at least the same misleading claims.

 
At February 19, 2009 , Blogger Ianthe said...

Another "benefit" of the "wonders of science."

Isn't it amazing how the human race survived and flourished all this time without it. What western medicine and U.S. medicine don't know, and how far behind they are the medicine of other cultures and civilization, is astounding.

I don't know what is being said in most of the comments here; it's all too technical for me. I just think the whole thing doesn't feel right and that's enough for me. Make these scientists go do some actual work, you know, labor, and make just enough money to survive, and they'd have a lot more sense. But no, they're scientists, they're doctors, they're respected, regarded as entitled, everyone in this society has a right to advance themselves...well there's the problem. And it comes from the same human exceptionalism that wants and feels entitled to the "cures" and thinks humans are special because they've made science. Can't have it both ways.

 
At February 20, 2009 , Blogger clauz said...

I dont mean to sound like a religious zealot because I am not, but these problems that arise with ESCR couldnt it be the way of God telling us that this is clearly not the way?

Either way, when you are trying out experiments no one really knows what will happen in the future. And this is what the patient should know...anything could happen for better or worse.

We are discovering today that drugs we deemed safe for a long time, they are not so much anymore. It takes years and years of research to actually learn a bit about the effects of treatments/medications/experiments. Some of the effects could be perhaps predicted, but there is always a lot of uncertainty about how the body will react even way after the procedures were carried out.

 
At February 20, 2009 , Blogger Bobby Bambino said...

Don,

I agree with you 100% about the PL movement. I cringe every time I see a pro-lifer argue against ESCR by citing the 73 to 0 statistic or talking about how there has been all this success in adult stem cell research but not ESCR. The reason is that it implies that IF ESCR were successful then we would support it which is certainly not the case. It's almost like we're utilitarians in that sense.

We need to shout loud and clear that we would be just as against ESCR had it found "cures" for every major disease or aliment because it kill nascent human life. Period.

 
At February 20, 2009 , Blogger JustChris said...

Dark Swan,

His analogy is correct. Particularly important then is the fact that I've heard some ESC researchers claim they can overcome questions about tumor growth by differentiating the cells before injecting them. Examples like that then prove it's not a forgone conclusion that you can "train" the ESCs into what you want and then expect them to behave. The bottom line is you never hear about this branch of science accurately reported in the mainstream media, only the positives and presidential candidates claiming "if you vote for us, quadriplegics will walk again."

Wow, 2 other people connected to WMU who are regular readers here... coincidence, or proof of the fine quality of Western Michigan University?

GO BRONCOS!

 
At February 20, 2009 , Blogger Lydia McGrew said...

I'd say it's evidence that southwestern Michigan is a relatively conservative part of the world, but that's a little misleading, as I am not a native but just ended up here when my husband got a job here. I've been here almost 14 years though, so maybe that counts.

 
At February 20, 2009 , Blogger Bobby Bambino said...

I also think Calvin College, being one of only two Christian Reformed Colleges in the US, attracts a lot of the very conservative, serious Christians to that area. But that's 3 minutes away from where I grew up, so maybe I"m biased :)

 
At February 20, 2009 , Blogger watchdog on science said...

The embryonic stem cell community has won the race by using empathy rather than scientific fortitude to promote human embryonic research. It appears that we will not be able to stop federal-funding of human embryonic stem cell research no matter how many people die in human experimentation or at the cost of human embryonic rights issues. We should, however, be able to place staunch controls on embryonic stem cell research since the public will be mandated to fund it.

But without freedom of speech and strong whistleblower laws for scientists and physicians, all the regulations placed upon this research community will be weak and essentially void. That is the problem we face right now. Without protections for scientists, public health and safety and regulated use of embryos are doomed.

 
At February 20, 2009 , Blogger bmmg39 said...

"I cringe every time I see a pro-lifer argue against ESCR by citing the 73 to 0 statistic or talking about how there has been all this success in adult stem cell research but not ESCR."

But that's just one prong in a two-prong argument. When people ask how we could be against a form of research that's "so promising," it's a good idea to set them straight by proving just how overhyped and unproved ESCR is. Then, when they ask, "Well, what's the harm in trying things that haven't been proven yet?" then we explain the ethical part of our opposition. That's still foremost.

 
At February 20, 2009 , Blogger Bobby Bambino said...

Yeah, that's true bbmg. I guess what I had in mind is those who argue against ESCR just out of the box that way; in other words, that it seems to be their main focus of argumentation rather than the humanity and moreover dignity of the embryo, which as you pointed out, should still be foremost. And you do put the argument in it's proper perspective. I just think many of us don't, and I fear that it may backfire if and when ESCR proves successful.

 
At February 21, 2009 , Blogger Lydia McGrew said...

"Calvin...attracts a lot of the very conservative, serious Christians to that area..."

No doubt true. Let's just hope they are still conservative, serious Christians by the time they leave. (He that hath ears to hear, let him hear. :-))

 
At February 27, 2009 , Blogger Ianthe said...

In my experience and observation, the minute "consent" becomes an issue, there may be trouble coming down the line. Someone hands you a "living will" to sign, it means someones want you dead, and "consent" means someone else is absolved of responsibility.

Oh, my Lord, just heard on the news that the Obama administration is erasing the Bush policy on protecting doctors and nurses who don't want to be involved in abortion. "What is this, Russia?" It's not the abortion issue per se that bothers me, it's the right of doctors and nurses etc. to adhere to their own ethics, about anything. And now Nancy Pelosi's voice comes over the airwaves saying that what Bush has done to the country is despicable. What's despicable, again?

 

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