Scrutinizing a Stem Cell Trial
Wired News has an interesting discussion of a clinical stem cell trial with the CEO of Geron, a California based stem cell company. The author takes time to discuss some of the process and hurdles that are faced by a company who wishes to engage in early clinical trials. From the article: "After an hour of speaking to Okarma, fears of a half-baked trial dissipated. He readily answered my many questions. If he didn't have the animal data to answer a query, he didn't try to dance around that fact. Okarma outlined a structured but malleable trial. I initially had reservations about safety, but Okarma emphasized that if the animal data is not good, the study will not move forward until problems are addressed."
In related news, stem cell transplants can repair injured spinal cords in rats!
Religion for nerds. Stuff that really matters
I wonder where medical science would be if society allowed more testing on homeless people? (not that I condone that, of course)
Religion for nerds. Stuff that really matters
Summary: This study had exactly the same oversight that every Phase I trial in the US has.
What I'm listening to now on Pandora...
What does it say about our society that I initially parsed "stem cell trial" in the headline as "a court case alleging illegal use of stem cells in research"?
http://alternatives.rzero.com/
What Ocomes around, Ogoes around.
Will posting this hurt my excellent Okarma?
-- Boycott Shell
"I initially had reservations about safety, but Okarma emphasized that if the animal data is not good, the study will not move forward until problems are addressed."
Don't believe that. Not because it's stem cells, not because Tom Okarma's a bad person (I have no idea about his character), but because that's not an independent, verifiable standard. Be happy that bad things should be avoided because some procedure is being followed and verified, not because you have a good feeling about a person. You want a process that deals with the honest folk and the dishonest folk just the same way, and works for both. Trust breaks the day you have a dishonest person on the other side of the table.
Still, I guess this is offtopic. It's an interesting article.
Why in the world do we need trials? Aren't they all guilty?
The best way to predict the future is to create it. - Peter Drucker.
This is the CENTRAL SCRUTINIZER...it is my responsibility to enforce all the laws that haven't been passed yet. It is also my responsibility to alert each and every one of you to the potential consequences of various ordinary everyday activities you might be performing which could eventually lead to *The Death Penalty* (or affect your parents' credit rating). Our criminal institutions are full of little creeps like you who do wrong things...and many of them were driven to these crimes by a horrible force called STEM CELL RESEARCH!
Our studies have shown that this horrible force is so dangerous to society at large that laws are being drawn up at this very moment to stop it forever! Cruel and inhuman punishments are being carefully described in tiny paragraphs so they won't conflict with the Constitution (which, itself, is being modified in order to accommodate THE FUTURE).
I bring you now a special presentation to show what can happen to you if you choose a career in STEM CELL RESEARCH...
He who knows best knows how little he knows. - Thomas Jefferson
I just don't get it. Why does everyone complain about using stem cells? Are they anti-vegetarians? Why do scientists act like they're in rare supply? Except for trees, most plants I've seen have stems.
--Average Slashdot reader
It's excellent that there are well balanced articles like this out there. Many tend to follow the anti-science trend that is taking over the US in recent years. Recently, the controversy over patient-specific stem cells has been used to rally the bible-beating troops against the use of embryonic stem cells altogether. Any sort of glance under the surface whatsover would immediately reveal that the scientific process worked exactly as it should, as it will in this clinical trial as well. Frankly, the results in animal models are quite promising, and if this treatment even mereley 'does no harm', I will be quite impressed.
Wanted: Assistant for lab. Will be required to break spines of rats for further research. Flexible hours. Bring own hammer.
The description would be better served by noting that this is EMBRYONIC stem cell research, not just stem cell research, as there are "other" stem cell technologies already in use.
When in danger or in doubt, run in circles, scream and shout. --Robert A. Heinlein
By the way the telomerase stuff that Geron is working on will be even more spectacular. And it's closer to phase II (universal anti-cancer agent GRN163L).
This treatment works the same way as Geron's. All-in-all, pretty cool.
Steven / Wired News
Overlords, and worship at their ever-increasing telomeric overproductive DNA strand replicative feet.
...
Or, I would, except I've noticed they have bizarre multi-nucleic aberrant patterns in later generations that makes it difficult to get mono-nucleic offspring in vivo as one would expect in the real world
Nobody ever talks about some of the side effects of what we do to get these lines going, since we're not permitted to create new cell lines, as any decent scientific experiment would demand.
-- Tigger warning: This post may contain tiggers! --
Okama:We've got the world's only GMP master cell bank of human embryonic stem cells with lines that are fully qualified for human use which, by the way, are two of Bush's approved lines. So the stuff you hear published that all of those lines are irrevocably contaminated with mouse materials and could never be used in people -- hogwash. If you know how to grow them, they're fine.
Perhaps some of the propaganda is anti-ethics in the name of science, poisoning the well towards those who have ethical objections and rallying the guys in lab-coats to oppose the "Bible-beaters"?
Not that anyone does that on slashdot...
Human being (n.): A genetically human, genetically distinct, functioning organism.
Okarma: It turns out that the differentiated cells that we make and put into animals are not recognized by the human immune system, and we published this last year. It's a striking finding.
Without immunosuppressive drugs I don't believe this. And even without it *should* increase the chance of gaining M.S.
There is a great pressure for scientists in this field to produce results (for money) and to move to clinical trials (because that is what motivates them, and what their backers want. But primarily it is what motivates them... to heal people). However, a lot of studies are very flawed, and it needs a lot of basic science to make sure that there are no repurcussions. Conversely the recipients tend to be the most desperate suffers, and this sways many ethics committees and researchers. I REALLY hope this works out for the best, but I am also deeply afraid it will cause more pain and suffering to the participants.
Also, there is a LOT of money going into not only spinal cord repair... there is repair of: stroke; M.S.; peripheral nerve injuries; Parkinsons's disease; Alzheimer's disease; motor neurone disease, and others that I cannot remember at this time. All ove these need cell replacement therapy, and all will be aided with ALL research into this area. However, BASIC research is the one area in neural repair, injury, degeneration and replenishment that will aid ALL of these areas.
I sometimes feel sick to my stomach at some of the studies that get published and then are lauded in the newsprint. However, I also get elation and hope from some others that offer true hope. I hope that this study is the latter.
Cheers,
maset