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FDA OKs First Human Trial of Neural Stem Cell Therapy

kdawson posted more than 4 years ago | from the spine-enhancing dept.

Biotech 149

An anonymous reader sends word that the FDA has approved a phase 1 trial for Neuralstem, a company with a patented stem cell procedure targeting ALS (Lou Gehrig's disease) and other spinal conditions. The company's CEO said in a press release, "While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process." Results are expected in 2 years. The trial will involve 12 ALS patients who will receive stem cell injections in the lumbar area of the spinal cord. An information site for the disabled community adds hopefully: "If it makes it through all stages of testing, we will see if doctors are willing to [use] it on subjects that have injuries coming from physical injuries like diving accidents."

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Wonder how this will cost (-1, Flamebait)

tjstork (137384) | more than 4 years ago | (#29509553)

Wonder how much the treatment will cost? How many kids don't get to eat at school so that someone gets this treatment.

Re:Wonder how this will cost (4, Funny)

Threni (635302) | more than 4 years ago | (#29509591)

Kids eat too much anyway - it'll do them good. How much does a sandwich and an apple cost, anyway? You're not going to fund much research for that.

Re:Wonder how this will cost (0, Troll)

ChefInnocent (667809) | more than 4 years ago | (#29509709)

A sandwich costs me about $20 to make. When I make it I have to buy new Miracle Whip cause the last one went moldy. That's almost $2. Then I buy a nice loaf of Potato Bread (usually Oroweat); about $4.5. If I don't have mustard, then that's another buck (but truthfully, mustard doesn't go bad any time soon so I usually have some on hand). A couple of roma tomatoes at $0.79/lbs, so figure another buck. A head of lettuce (preferably green leaf or butter) which varies wildly over the year, but say $1.25 for that 'cause it's summer. Then I need some deli style ham and that runs about $4-$5. If I'm making a BLT instead, I'm still paying $4-$5 for a pound of bacon. Since I'm having a sandwich, I need Frito-Lays which are usually around $3. I also need some cottage cheese for another $2.5 and a piece of fruit to slice (which is where your apple comes in) and put on the cottage cheese for another $0.75. Then to put all this down, I need a nice glass of cold milk, so I spend another $1.75 on a quart of whole milk unless I'm feeling particularly good, then I go over to the dairy and buy theirs for $2.50 cause it is way better than I can get at the store.

Re:Wonder how this will cost (1)

bmecoli (963615) | more than 4 years ago | (#29509859)

A head of lettuce (preferably green leaf or butter) which varies wildly over the year, but say $1.25 for that 'cause it's summer.

Apparently you didn't get the memo. It's fall now.

Re:Wonder how this will cost (1)

swanzilla (1458281) | more than 4 years ago | (#29510045)

When itemizing the cost of one's sandwich, one should subcategories sandwich accompaniments. Said accompaniments, while worthy of note, tend to overestimate sandwich-specific cost.

Re:Wonder how this will cost (1)

Arthur Grumbine (1086397) | more than 4 years ago | (#29510179)

I was going to go through your currently "Insightful" post line-by-line, questioning the need for the pounds of food you require to make a single sandwich, but in the interest of charity I will just assume you are either Dagwood Bumstead, The Flash, The Incredible Hulk, or just morbidly obese. Seriously, though: a loaf of bread, a pound of bacon/ham, a jar of Miracle Whip, a head of lettuce, and a large bag of fritos?! Good thing you snuck in a couple healthy cups of cottage cheese and a piece of fruit to balance it out.

Re:Wonder how this will cost (1)

rhathar (1247530) | more than 4 years ago | (#29510523)

Obviously he should go to the grocery store and only buy the two slices of bread, four strips of bacon, single leaf of lettuce and tablespoon of mayo he needs.

Or maybe, just maybe, the point was that there is a certain minimum amount of purchasing required to make food at home, a minimum that makes the occasional sandwich ridiculously expensive.

If I only eat a sandwich once a week or less, it is much more cost effective to buy one at the deli then try and store perishable goods I won't be using.

Re:Wonder how this will cost (1)

ChefInnocent (667809) | more than 4 years ago | (#29510525)

No. The problem is that the store doesn't sell bread by the slice (for which I would need 4 slices). The bacon I buy comes in a 1lbs package (about 3 slices per sandwich). The Miracle Whip, like the bread, comes by the container which is way more than I would use (about 1/2-1 tsp). The Fritos, though in a similar boat to the other items, tends to be doled out over days, but I buy it to make the sandwich meal complete (Actual use with meal: 1/4-1/2 cup).

Why it was "insightful", I'm not sure. Although I am being honest in saying it costs me about $20 to make a sandwhich, I was trying to be funny. A sandwich for 1 guy can cost a bit since I make about 2 sandwiches a year. Most of it goes to waste. The bread is moldy after being shoved in the back corner of the cupboard by the time I need it again; the "mayo" will expire on the refrigerator shelf, and the lettuce and left over tomato will wilt in the crisper. If the Fritos are not taken to work, then sadly they will go stale. On the good side, bacon never goes to waste. It will be accompanies on Saturday with some eggs and pancakes (I don't really like toast).

Re:Wonder how this will cost (2, Informative)

Anonymous Coward | more than 4 years ago | (#29510421)

That's a hell of a sandwich if you're using the whole tub of Mayo, a pound of tomatoes, a whole loaf of bread, a pound of bacon, a whole head of lettuce, and alongside it a 10 serving bag of fritos, and then drinking a whole quart of milk? Can I ask what your BMI is?

In reality, it's more like this. You use 1/25th of the tub of mayo, so 1/25 of $2 is really more like 8 cents. Hell, let's say you're generous. 25 cents. We'll assume it's one of the nice loaves of bread that only has like 10 slices. so 1/10th of the $4.50, so .45. Let's assume you use 2 romas (they're kinda small) on the sandwich. In my experience that's at most around a half pound. So we'll round and say .40. 3 leaves of lettuce is about 1/10th of a head if it's a medium sized head of lettuce, so rounding up to .13. We'll go with the bacon since you told us volume there, heck, let's make a bacony BLT. 4 thick slices accounts for .30 pounds I'd wager, so that's $1.35 (most expensive item so far!) A single serving bag of Fritos runs 40 cents after tax (they're those 3 for a dollar bags). We'll assume you eat the whole fruit. Finally, 2 servings of milk (we'll even go with the good dairy one you mentioned) would only be half of the quart, so round that up to 88 cents.

The REAL cost of your sandwich would be $4.61. Give or take.

Now if you bought that sandwich at a sandwich shop, yeah it'd be like 15 bucks. Mmmm, capitalism.

Re:Wonder how this will cost (2, Funny)

icebike (68054) | more than 4 years ago | (#29509623)

Ah, does that really matter?

Kid goes to school, then has to spend every cent taking care of a failing parent. Parent dies anyway, kid broke for life.

Kid doesn't go to school, gets a job, puts self thru school, and both parent and kid come out better.

Re:Wonder how this will cost (2, Insightful)

jcr (53032) | more than 4 years ago | (#29509669)

I see you did well at Economic Fallacy School.

-jcr

Re:Wonder how this will cost (1)

internettoughguy (1478741) | more than 4 years ago | (#29511371)

It's hardly an economic fallacy, if the researchers left the field of biology, and entered the field of wheat (sickle in hand) then they may be able to fill some stomachs.

...on the other hand he is a definite hypocrite for suggesting that people doing science are wasting their time, when he's pissing around on /. all day.

Re:Wonder how this will cost (1, Insightful)

Anonymous Coward | more than 4 years ago | (#29509677)

Wonder how much the treatment will cost? How many kids don't get to eat at school so that someone gets this treatment.

I assume you have the same concern about every single medical procedure ever invented?

Re:Wonder how this will cost (-1, Troll)

PopeRatzo (965947) | more than 4 years ago | (#29509911)

I assume you have the same concern about every single medical procedure ever invented?

No, he's not concerned with any medical procedures at all. He's a conservative, so he doesn't go to doctors, he just prays.

Re:Wonder how this will cost (3, Informative)

Chris Burke (6130) | more than 4 years ago | (#29509681)

Wonder how much the treatment will cost? How many kids don't get to eat at school so that someone gets this treatment.

Don't worry, the people who can't afford lunch for their kids will be the same ones who can't afford this treatment. So nothing you would be concerned with.

Re:Wonder how this will cost (1)

geekoid (135745) | more than 4 years ago | (#29509685)

WTF?

That website is horrible and factually wrong.

Re:Wonder how this will cost (2, Funny)

Arthur Grumbine (1086397) | more than 4 years ago | (#29510217)

WTF?

That website is horrible and factually wrong.

What's that you say?! A troll has a link in his sig to a website that is wrong!?! Rally the Internet Justice League - this evil cannot be allowed to stand unopposed!!!

Re:Wonder how this will cost (1, Insightful)

Anonymous Coward | more than 4 years ago | (#29509723)

Well geez, how else do you propose we pay for it? It's not like we can just stop attacking foreign countries and killing thousands of civilians, can we?

Re:Wonder how this will cost (1)

whargoul (932206) | more than 4 years ago | (#29509833)

Found step 2!

1. Attack foreign countries ( killing thousands of civilians )
2. Feed children dead civilians
3. Profit!

Soylent Green, it's what's for dinner.

Re:Wonder how this will cost (1)

Daniel Dvorkin (106857) | more than 4 years ago | (#29509845)

Wonder how much the treatment will cost? How many kids don't get to eat at school so that someone gets this treatment.

Feel free not to have the treatment if you get ALS. You know, For The Children and all.

Except that's not what will happen and you damn well know it. If you're diagnosed with a horrible and deadly disease, you will personally knock a million lunches out of a million hungry, adorable, big-eyed schoolkids' hands, and laugh at them while they cry, if that's what it takes to get you a cure.

Re:Wonder how this will cost (1)

Beardo the Bearded (321478) | more than 4 years ago | (#29510071)

If it was my kids, it would be worse:

"Excuse me. If you're sick, you can have my sandwich if that will make you better."

Imagine it with the 5-year-old lisp.

Re:Wonder how this will cost (2, Informative)

fuzzyfuzzyfungus (1223518) | more than 4 years ago | (#29510839)

There's also the fact that taking care of somebody who is slowly dying of ALS isn't exactly free. Nor(on average) are the lost years of life.

There are certainly medical treatments that will never be viable in economic terms, that are available(or not) basically for ethical/humanitarian reasons. However, cures for diseases that would otherwise involve a number of years of expensive decline and an early death may well not fall into that category. Because R&D is expensive, the per-case cost of the first round is going to be crazy; but volume use could end up being a win in purely financial terms, not to mention the obvious non-monetary benefits of less painful lingering death.

Re:Wonder how this will cost (0, Flamebait)

interkin3tic (1469267) | more than 4 years ago | (#29510571)

Wonder how much the treatment will cost? How many kids don't get to eat at school so that someone gets this treatment.

This website [costofwar.com] estimates 700 billion dollars in direct costs, if we figure a school lunch costs somewhere in the neighborhood of 7 dollars (have no idea what the actual average cost would be,) that's about 100 billion lunches I guess. Somewhere in there.

Oh wait a minute, you said treatment, as in the spinal cord repair. I thought for a minute you were talking about the Iraq war, Mr. Center-right conservative. Sorry, my bad.

I have no idea how much the treatment will cost. Pocket change to us, but as I always say, a tax dollar spent on something besides bombing someone is a terrible waste of a dollar.

Re:Wonder how this will cost (1)

izomiac (815208) | more than 4 years ago | (#29511893)

Zero. Children getting free lunches netted my county's school food program more money than the full paid children. A neighboring county that was a bit higher percentage-wise for Free (or Reduced Price) VS Full Paid was able to go to 100% free lunches (i.e. eat the loss for the non-free kids). So the school food program is acceptably compensated to feed low income children.

The grants from the federal budget that helped fund this research (or the background research) didn't change that. Nor is it like a kid will go hungry because their parent can't afford to pay for school lunches (many poor kids only get to eat at school, not at home except during the summer and weekends).

Dr. Stephen Hawking (3, Insightful)

Anonymous Coward | more than 4 years ago | (#29509561)

Any chance that this could be passed through quick enough to prolong a certain genius' life?

Re:Dr. Stephen Hawking (1, Interesting)

reverseengineer (580922) | more than 4 years ago | (#29509781)

Probably not, to be honest. If they're just starting Phase I right now, figure on at best 6-8 years or more before a possible approval by regulatory agencies, which naturally assumes that this treatment would be demonstrated as both safe and efficacious. Phase I doesn't take much time, but Phases II and III can easily take years- particularly for a disorder like ALS, where patients would need to be monitored for months to determine the treatment's effects. In Stephen Hawking's particular and remarkable case, it is not merely the progression of his ALS that would be an issue; the man is 67 years old right now.

Re:Dr. Stephen Hawking (-1, Troll)

Anonymous Coward | more than 4 years ago | (#29509871)

Fuck Hawking

Re:Dr. Stephen Hawking (1)

PopeRatzo (965947) | more than 4 years ago | (#29509927)

Fuck Hawking

Yeah, he thinks he's so smart...

Oh, wait...

Nevermind.

Re:Dr. Stephen Hawking (1, Funny)

Anonymous Coward | more than 4 years ago | (#29509929)

Not to be confused with 'Hawk Fucking', which is a new sport in some parts of the world. And unlike the above post, actually has some minimal value.

Re:Dr. Stephen Hawking (0)

Anonymous Coward | more than 4 years ago | (#29509931)

Fuck Hawking

I would.

Re:Dr. Stephen Hawking (1)

Orion Blastar (457579) | more than 4 years ago | (#29511115)

Well Dr. Hawking it will take two years just on the test subjects to see if there is any progress. As a man of science you should know that these sort of things cannot be rushed and the scientific method has to be followed and the work peer reviewed.

You've made it this far, chances are you can make it until they find a cure for ALS. I am certain after the trials are done and the procedure is ready for the public, you'll be on the top of the list because of your scientific importance.

Some in your situation may resort to prayer, and I am not sure if you are a religious man, but being that you beat dying of ALS all these years, it may be certified as a miracle of some sort. I am a scientific and religious man, and I'll be praying for you to keep living until the stem cell cure for ALS is discovered. I mean that in the best way, and don't mean to be offensive.

Re:Dr. Stephen Hawking (1)

bobbuck (675253) | more than 4 years ago | (#29511381)

If it were that promising he could leave the country to have the treatment before the approval.

Send it to congress (0)

Anonymous Coward | more than 4 years ago | (#29511455)

they will pass just about anything really fast, without reading it or concerned about the outcome.

Re:Dr. Stephen Hawking (2, Insightful)

Bruce Perens (3872) | more than 4 years ago | (#29511589)

He's 67. It might not be ALS that kills him.

Big News? (3, Insightful)

lobiusmoop (305328) | more than 4 years ago | (#29509577)

It makes me sad that this is news in 2009. This should really have been commonplace research by now.

Re:Big News? (0, Flamebait)

jcr (53032) | more than 4 years ago | (#29509687)

Well see, we have this massive bureaucracy in the USA called the "Food and Drug Administration", whose job it is to kill people by impeding medical research.

-jcr

Re:Big News? (2, Insightful)

geekoid (135745) | more than 4 years ago | (#29509755)

oh shut it. Far fewer people have dies waiting on something then would ahve if they just rushed or ignored testing.

Re:Big News? (1)

Romancer (19668) | more than 4 years ago | (#29509877)

Holy crap. Your post actually proved your point about waiting and testing, or in your case proof reading. :)

But your point is a small one if that in the perspective of medical testing. I think that people would get a fair shake if they were allowed to participate in the medical testing phases of these drug trials and were given the choice. There is quite a large number of people out there that are terminally ill and suffering. They are looking forward to death to get away from the pain and drug induced mental state that they are prescribed to try and combat that pain. The choices in front of them are:

1. Take enough pain medication to dull the pain to a tolerable level and miss out on life since it's a trip now.

2. Try and tolerate the pain to be able to remember and converse with those they love but in doing so have to watch the looks on their faces as they see such pain and suffering. (also the PAIN can cause blackouts depending on the conditions)

3. Get in a drug trial to possibly have an extended period of lucidity and responsiveness to pain medications/treatments that would possibly extend their life.

Given an educated choice when not even in that much pain I think that prohibiting those that would from entering into the testing phases is not an easy choice. You'll have the get rich crackpots that think Draino will cure cancer and want to do the trials but a basic first level test would weed out the vast majority of those so that the others could start testing on the human equivalent * sooner and then move to human testing before thousands die without a chance. The cost of the basic screening and the choice of those that would offer their last months or years for the possibility would be a good thing I would think.
*(Human analogs need not be live animals BTW, they can be lab grown organs or cells)

Re:Big News? (3, Insightful)

PopeRatzo (965947) | more than 4 years ago | (#29509945)

You think it's the FDA that's been holding up stem cell research, and not the religious yahoos?

Re:Big News? (2, Insightful)

geekoid (135745) | more than 4 years ago | (#29510033)

His point was a more overall shot at the FDA process.

You are correct, it's the religious jack asses that claim to want a free country but then shove there magic fairy views down everyone else throat that have us 8 years behind in our research.

Re:Big News? (1)

compro01 (777531) | more than 4 years ago | (#29510039)

You assume they are distinct groups.

Re:Big News? (1)

TheVelvetFlamebait (986083) | more than 4 years ago | (#29510289)

He also assumes the world is round, the sky is blue, and the sun rises in the east. What's your point?

Re:Big News? (0)

Anonymous Coward | more than 4 years ago | (#29510881)

That unfortunately not everyone in the US actually believes your statement there.

Re:Big News? (1)

Kuroji (990107) | more than 4 years ago | (#29511121)

Of course the world is actually somewhat oblong, the sky itself doesn't have a color and the sun doesn't move so much as the earth spinning in relative motion to it.

Certain assumptions only make sense in a certain context.

Tax funded embryonic stem cell research (1)

bobbuck (675253) | more than 4 years ago | (#29511393)

The religious yahoos are only holding up tax funded embryonic stem cell research...

Re:Big News? (1, Interesting)

Brian_Ellenberger (308720) | more than 4 years ago | (#29511889)

You think it's the FDA that's been holding up stem cell research, and not the religious yahoos?

The only thing "held up" was federal funding for stem cells that resulted in destruction of the embryo/fetus. The research was not banned in any way. It did not affect any stem cell research from cells taken from your own body (which have the added benefit of being much less likely to be rejected). Nor did it affect Amniotic cells.

There are more legal hurdles right now to test on animals (which Neuralstem admits to doing), than stem cells. And if the animal rights crowd gets their way, this research area is toast because no one is going to experiment on humans without animal trials first. But keep blaming "religious yahoos" for all the problems.

The whole "evil religious people are against stem cells" is a typical wedge issue cooked up by politicians to get you away from looking at the arguments and issues and vote in a knee-jerk "Good vs Evil" mentality that makes you so darn easy to control. Animal testing is a complex argument around what does it mean to "feel" pain, etc. Well, guess what, there is a complex moral discussion surrounding whether it is a good idea to chop up embryos/fetuses and use them for spare parts. You know, kinda like what does it really mean to be human, what is morality, etc. In a way, it sounds vampirish -- to consume the cells of another entity with human DNA to improve your own health. Potentially, create a child and abort it so you can live longer. How close do you want to go to people as "spare parts"? You should at least understand and sympathize a little bit that a large number of people in a representative government may not want their tax money to go to something like that.

To reduce it down to calling people "yahoos" is inane.

Re:Big News? (1)

geekoid (135745) | more than 4 years ago | (#29510011)

"I think that people would get a fair shake if they were allowed to participate in the medical testing phases of these drug trials and were given the choice"

Perhaps, but how do you do that and keep the study valid?

4. Get in drug trial and die.

5. Drug gets released and due to failure in the blinded study it is ineffective or worse, kills people.

"*(Human analogs need not be live animals BTW, they can be lab grown organs or cells)"
That's very nmoce for certian tests, but not a good overall tests.

Seriously, people have been dealing with these issues forever. It's a hard one for people who actually understand the science process and the value of good studies.

Re:Big News? (1)

Romancer (19668) | more than 4 years ago | (#29510519)

"I think that people would get a fair shake if they were allowed to participate in the medical testing phases of these drug trials and were given the choice"
Perhaps, but how do you do that and keep the study valid?

By the history and diagnosis of the patients as terminally ill entering a study and having reactions. It's not being presented here that it would allow the statistics to be directly entered with the rest of the data since these are extreme cases. But if you can say that so many people that were terminally ill lasted well beyond their estimated time of death VS those that did not recieve treatment. That's just added data for the study isn't it? And you get to possibly help people or at least give them hope.

"*(Human analogs need not be live animals BTW, they can be lab grown organs or cells)"
That's very nmoce for certian tests, but not a good overall tests.

Seriously, people have been dealing with these issues forever. It's a hard one for people who actually understand the science process and the value of good studies.

First I really don't know what you mean by "That's very nmoce for certian tests, but not a good overall tests."
I'm not mocking or joking, I really don't get that sentence for the most part. But to the "not a good overall tests" If that's not good for overall testing then I didn't say it was, just that I didn't want to offend others that may think I was saying to perform more animal testing and get off topic. I didn't want to bring that into this.

Just because people have been dealing with these issues doesn't mean that they are doing it right and couldn't benifite from some outside perspective once in a while. There are some benifits in PR to be had from opening these up for earlier testing since the alternative is so grave.

Re:Big News? (1, Interesting)

jcr (53032) | more than 4 years ago | (#29510001)

Far fewer people have dies waiting on something then would ahve if they just rushed or ignored testing.

So, do you believe that you're entitled to make that decision for someone else? If you don't have the right to do it, then neither does a government.

-jcr

Re:Big News? (1)

hot soldering iron (800102) | more than 4 years ago | (#29511725)

I personally agree with your sentiment, that withholding possible treatment from the dying because "it's not tested" isn't valid. I mean, yes, they could die. Oh, wait...

Your statement about "rights" pricked a sore spot with me, though...
"Rights" are entitlements secured by popular consensus, or force. You think that what's "right" or "acceptable" for an individual defines right and acceptable behaviour for a government? Nice idea,but an individual is supposedly held responsible for their individual actions, but as the "individual" becomes a larger and larger group, the responsibility per person becomes less and less, and the willingness to use force accumulates. Thus, a government, any large ruling body, accumulates power, and "rights", and becomes more prone to violence.

Re:Big News? (1)

Romancer (19668) | more than 4 years ago | (#29510273)

Then there's the flip side of that coin. I'm sure someone will remember the movie but the point stands as a reasonable example.

The trials have to have a baseline or control group usually and that means a placebo or no treatement for those unlucky ones in the trial.

So you have a group that is suffering from an ailment and they get into a trial and then don't get treated anyway. So while the drug was being delevoped and during the testing and all the way up until it is released to market, the person doesn't get treatment. This can take decades for some companies although 12 years is common. During that time people will have died. If the drug is worth anything and would have saved lives, a percentage of that number are those that drug testing didn't save during the trials.

I'm not saying that the trials are completely heartless or wrong, but that there are multiple sides and perspectives that have to be addressed in this issue.

Read up on it:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm [fda.gov]

Re:Big News? (1)

bnenning (58349) | more than 4 years ago | (#29511013)

That is far from clear. It's obviously hard to determine the counterfactual numbers, but there are estimates that FDA testing delays kill many more people than they save [fdareview.org] . And in the case of a terminal illness like ALS, there's a substantially reduced downside if the treatment turns out to be harmful so it makes sense to be more aggressive.

Re:Big News? (3, Informative)

Daniel Dvorkin (106857) | more than 4 years ago | (#29509799)

Well see, we have this massive bureaucracy in the USA called the "Food and Drug Administration", whose job it is to kill people by impeding medical research.

The job of the FDA with regards to medical research is to ensure that what's called "medical research" is actually both "medical" and "research" by reasonable definitions of those words. Do you really not understand why this is necessary?

Re:Big News? (1)

hedwards (940851) | more than 4 years ago | (#29509857)

Don't mind him, he's just from the small government crowd. Obviously, we should just remove all regulation and let the markets decide who lives and who dies.

Re:Big News? (1)

PopeRatzo (965947) | more than 4 years ago | (#29509953)

Obviously, we should just remove all regulation and let the markets decide who lives and who dies.

Quite right, Mr. Gingrich. It's almost time for bed now sir, so if you don't mind, please turn off the computer and take your medicine.

Re:Big News? (0)

jcr (53032) | more than 4 years ago | (#29509959)

Obviously, we should just remove all regulation and let the markets decide who lives and who dies.

More like, we should leave it up to the patients and the providers to decide what treatments they want to use, instead of having to supplicate to the commissars of the FDA and other government agencies for permission. In case you haven't noticed, governments are really noted for compassion or valuing human life.

-jcr

Re:Big News? (1)

blackraven14250 (902843) | more than 4 years ago | (#29510877)

Corporations aren't noted for having any regard for human lives. They would kill everyone outside of one big city if they knew it meant many more people moved into the city that they completely control.

I think the solution to this is to have an opt-in for patients to join the trials at any time (pairs of 2 for control/variable groups), rather than a closed selection of candidates. Give them an explanation of the risks, and let them make a choice.

Re:Big News? (1)

Jafafa Hots (580169) | more than 4 years ago | (#29511247)

Corporations aren't noted for having any regard for human lives.

That's just not true. They regularly take human life into consideration. If the cost of making sure their product doesn't kill you is less than the cost of paying the occasional fine, the occasional family that bothers to sue, and the everyday routine expense of paying off legislators... well then, you're worth saving!

Corporations (2, Insightful)

bobbuck (675253) | more than 4 years ago | (#29511473)

Do you mean like McDonalds that runs the Ronalds MacDonalds Houses so that the parents of sick children have a place to stay or Eli Lilly that has funded millions of dollars in scholarships? Get a clue.

Re:Big News? (1)

jgtg32a (1173373) | more than 4 years ago | (#29511961)

Bodies are bad for business

Re:Big News? (0)

Anonymous Coward | more than 4 years ago | (#29509847)

I would like to argue that it's the political folks who slow this down, not the regulatory wonks...

Re:Big News? (1)

Snarkalicious (1589343) | more than 4 years ago | (#29509933)

Thalidomide.

Re:Big News? (0)

Anonymous Coward | more than 4 years ago | (#29510469)

Ugh. I don't like that word.
(It does remind me of We Didn't Start the Fire, tho.)

Re:Big News? (1)

areusche (1297613) | more than 4 years ago | (#29510307)

I wouldn't call the FDA at fault. I would call the massively ignorant christian right in the United States at fault.

Re:Big News? (0)

Anonymous Coward | more than 4 years ago | (#29510411)

Mhmm. I blame large groups of unorganized people when I don't agree with popular opinion too. You misspelled "the unwashed masses".

Re:Big News? (1)

interkin3tic (1469267) | more than 4 years ago | (#29510637)

Well see, we have this massive bureaucracy in the USA called the "Food and Drug Administration", whose job it is to kill people by impeding medical research.

I was going to say that cells have this massive "bureacracy" they call "normal cell biology" that makes nearly everything else look like a children's book, and that tends to slow down research. And there are other "bureacracies" like

-A complicated central nervous system
-Ethics
-Lack of resources
-Researchers need to sleep, eat, go to the bathroom, play videogames, etc
-The fact that no one really has figured out how to repair a central nervous system and we don't have a crystal ball that will tell us these things

that really bog down the process even further. I'd write a letter to God (all of them), whoever established rules of causality in our universe, whoever/whatever designed/caused us to evolve this way, and the first multicellular organism complaining. With all those bases covered, we're sure to get things changed so we can finally get somewhere fast with medical research.

Re:Big News? (1)

jgtg32a (1173373) | more than 4 years ago | (#29511955)

The only difference between a bureaucrat and any given cell; cells strive for efficiency
http://arstechnica.com/science/news/2009/09/nerve-cells-have-an-energy-efficiency-an-engineer-would-love.ars

Re:Big News? (3, Insightful)

Bruce Perens (3872) | more than 4 years ago | (#29511623)

Well see, we have this massive bureaucracy in the USA called the "Food and Drug Administration

Were you aware that there are other countries? :-)

All of the folks arguing about health care don't make the connection that Hawking has lived so long in a country with socialized medicine.

Re:Big News? (0)

Anonymous Coward | more than 4 years ago | (#29511901)

I take it you've never heard of Frances Oldham Kelsey? How about Thalidomide?

One of [Kelsey's] first assignments at the FDA, was to review the application by Richardson Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquiliser and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Even though it had already been approved in over 20 European and African countries, she withheld approval for the drug, and requested further studies. Despite pressure from thalidomide's manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.
Kelsey's insistence that the drug should be fully tested prior to approval was dramatically vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.

Re:Big News? (1)

Trepidity (597) | more than 4 years ago | (#29509759)

How so? The earliest versions of the technique only date back to about 2002, and I don't see any evidence that research has been slower than one might expect.

Re:Big News? (0)

Anonymous Coward | more than 4 years ago | (#29509831)

You can thank the market economy and IP law for that.

Re:Big News? (1)

Trailer Park Boy (825146) | more than 4 years ago | (#29510449)

It is common place in much of the world (think China). It's US research that's been held back. But I do agree, it is sad.

can we have a comparison group? (-1, Troll)

Anonymous Coward | more than 4 years ago | (#29509653)

Can one of the comparators be prayer from a religious person not affiliated with the subject? I'd love to see how it fares in the face of real science. Can every clinical trial have that as a control group? Or, how about prayer alone vs. prayer + treatment. What if the treatment is superior? Then it is more powerful than prayer, which contradicts many religious teachings! Remember, the prayers should come from a third party, no one should know they are being prayed for!

Re:can we have a comparison group? (2)

PopeRatzo (965947) | more than 4 years ago | (#29509969)

There have been several studies involving prayer and healing, with extensive double-blinds.

It only make the person who prays feel better, which is no small thing, but praying for someone else does not promote healing.

In the case of certain sects who believe in prayer instead of medical treatment, it actually promotes death.

Re:can we have a comparison group? (0, Redundant)

TroyM (956558) | more than 4 years ago | (#29510929)

It's always seemed strange to me that an all knowing, all powerful, and just God, won't help a sick person unless somebody else asks Him to.

What kind of stem cells? (1)

zaft (597194) | more than 4 years ago | (#29509663)

I read TFA and I still don't understand if these are embryonic stem cells or adult stem cells... anyone?

Re:What kind of stem cells? (1, Informative)

Anonymous Coward | more than 4 years ago | (#29509689)

As far as I can tell from the radio interview at the top of their news page [neuralstem.com] , they are adult stem cells from the brain.

Re:What kind of stem cells? (3, Informative)

interkin3tic (1469267) | more than 4 years ago | (#29510047)

That's what I'm guessing too. TFA is ridiculously underinformative. Neuralstem doesn't seem to be talking specifics for some reason.

A video on their website [neuralstem.com] was -slightly- more informative. They make lines of neural stem cells and inject them into the damaged part. That to me was somewhat questionable. Injecting undifferentiated, replicating cells into your central nervous system, even if they're neural stem cells sounds dangerous. You want the specific type of neuron there, and enough glial cells. Without directing their differentiation, I would expect you'd end up with a random mix of cells, or possibly a glioma [wikipedia.org] .

It mentioned that these were patented methods. I don't know much about patents, but I did find this patent [patentstorm.us] issued to neuralstem biopharmecuticals ltd (same company?).

The abstract to that patent:

A systematic and efficient method for establishing stable neural stem cell lines and neuronal progenitor lines is described. The resulting cell lines provide robust, simple, and reproducible cultures of human and other mammalian neurons in commercially useful mass quantities while maintaining normal karyotypes and normal neuronal phenotypes.

What it actually seems to cover is nothing revoultionary. They isolate a neuronal stem cell, culture it in a wide variety of commonly used growth factors for 30 divisions, transfect the C myc gene, and then culture it in the same growth factors and/or whole serum. That's to make a line of cells. C-myc by the way was one of the transcription factors used to make induced pluripotent stem cells, and is associated with many cancers, which is worrisome. Nothing in that really suprises me. I'd be interested to hear from slashdot's armchair lawyers (or real lawyers) as to whether or not you can simply patent a combination of common techniques to make a line of stem cells.

What is more interesting to me is another patent that Neuralstem has [patentstorm.us] , Use of fuse nicotinamides to promote neurogenesis.
The abstract for that one:

The present invention provides a group of compounds found to increase the number of neurons derived from stem cells for use as a therapeutic agent in neurological conditions or diseases. In one embodiment of the present invention, the compounds are used to detect the mechanism by which the number of neurons is increased.

I'm less of an expert on this, it's a lot of biochemistry I'm not familiar with, but from the summary:

the present invention is related to classes of compound structures that are shown to be particularly effective in promoting neurogenesis includingcompounds of the type, fused imidazoles, aminopyrimidines, nicotinamides, aminomethyl phenoxypiperidines and aryloxypiperidines

It seems they have a patent on compounds which have been shown to nudge stem cells towards making neurons. This might be their answer to the first problem I mentioned: not wanting to inject undifferentiated cells into your spine or brain.

I'm guessing their technique involves 1. Surgery to get tissue samples which would be enriched in neural stem cells (I've heard the cells next to the ventricles in your brain are good spots for that) 2. They take those cells and put them in their culture media that causes the stem cells to divide 3. They transfect c-myc to increase the yeild 4. They harvest the undifferentiated cells and incubate them with their differentiation compounds before or as they 5. Inject the mix into your damaged spinal cord.

If they moved on to humans, I'm guessing they've already demonstrated this works to a degree and doesn't cause a lot of cancers in mice or other animal models. The results on that are probably published, but I've wasted enough time here.

Re:What kind of stem cells? (0)

Anonymous Coward | more than 4 years ago | (#29510567)

This ignores the fact that stem cells take their orders about what to become from their neighbors, and from specialized cell groups called Fibroblasts.

These structures would still be present in a person with Lou Garrig's disease (how ever you spell that.) since these structures form during ebryonic development in humans. As long as the symptoms are mild to moderate, the fibroblast matrix network should be unharmed, and the stem cells would migrate in and correct damaged tissues without issue.

The problem would come from tissue areas where the fibroblasts have formed a matrix that is nonsense, such as with heavy neural scarring. In which case, the immigrant stem cells would take orders from a confused mass of scar tissue precuror matrix, and really screw stuff up in there.

Re:What kind of stem cells? (1, Insightful)

interkin3tic (1469267) | more than 4 years ago | (#29511125)

This ignores the fact that stem cells take their orders about what to become from their neighbors

I think that part alone is oversimplifying things, but what exactly ignores that? The growth factors listed in the patent are the same factors present in the niche where these stem cells are maintained, combinations of them keep the stem cells proliferating while they're expanding the isolated stem cells. The second patent, the chemicals which induce neuronal development, presumably do so through the same signaling pathways used by the microenvironment to direct neural stem cells to differentiate.

If you're implying that just dumping stem cells into a wound site in the CNS would be enough to patch the damage, you should know that there have been some trials testing that. They ended poorly for the mice. I believe some researchers in China tried it on human patients anyway, they developed teratomas and died quickly as I recall. Teratomas are the result of stem cells differentiating inefficiently. Even stem cells which have started to go down the neuronal path would have to be directed. For one thing, I'd worry that all the cells would turn into glial cells, no neurons. The CNS seems reluctant to add new neurons, wheras some glial cell populations get replentished.

I'd expect just dumping stem cells on the hole would be a little like trying to repair a hole in the side of a building by throwing wet concrete at it.

and from specialized cell groups called Fibroblasts.

Fibroblasts aren't cell groups, they are cells. A fibroblast is a cell [wikipedia.org] . I don't believe they instruct neural stem cells though I could be wrong about that. Notch signaling: the neural stem cells appear to regulate their own populations. There are other factors, some that I'm not too familiar with, but I've never heard anything suggesting fibroblasts regulate neural stem cells, and they certainly aren't the only things regulating them. Fibroblasts definitely do not regulate all stem cells.

These structures would still be present in a person with Lou Garrig's disease (how ever you spell that.) since these structures form during ebryonic development in humans.

Fibroblasts are present in adults, but I disagree with the logic of "they should still be there since they were there in embryonic stages." You also have gills as an embryo. Those don't stay. Most of your neural stem cells also dissapear early in life.

Re:What kind of stem cells? (1)

Corporate Drone (316880) | more than 4 years ago | (#29511615)

That's what I'm guessing too. TFA is ridiculously underinformative. Neuralstem doesn't seem to be talking specifics for some reason.

I'm guessing their technique involves 1. Surgery to get tissue samples which would be enriched in neural stem cells (I've heard the cells next to the ventricles in your brain are good spots for that)

So, if I understand you correctly, you're guessing that they're adult stem cells, not embryonic stem cells? That might answer your implied question of why Neuralstem isn't talking specifics -- stem cell research is only cool when it's embryonic stem cell research... ;)

Re:What kind of stem cells? (2, Funny)

geekoid (135745) | more than 4 years ago | (#29509785)

Why does it matter?

Re:What kind of stem cells? (2, Interesting)

Anonymous Coward | more than 4 years ago | (#29509853)

Why does it matter?

One reason it matters is that we are forever being told how embryonic stem cell research is going to find the cure for every disease under the sun, and anyone who thinks the money should be diverted to research into stem cells from alternative sources is a religious nut who should shut up, yet of nearly 100 current treatments using stem cells, there is not a single one that uses embryonic stem cells. If this were better known, then all the resources being wasted on this dead-end research could perhaps be used more profitably.

Re:What kind of stem cells? (2, Insightful)

BlueParrot (965239) | more than 4 years ago | (#29510741)

One reason it matters is that we are forever being told how embryonic stem cell research is going to find the cure for every disease under the sun

Bullshit.

There are a number of people who repeat that straw-man for political and religious motives, but what promoters of embryonic stem cell research usually argue is something more along the lines of:

"Embryonic stem cells are worthy of research not only because understanding how they differentiate can help us understand how to better use adult stem cells, but also because they have a number of unique features that make them promising to be useful for a number of conditions where adult stem cells would not suffice (such as tissue types that lack adults stem cells, like the pancreas). In any case history suggests that understanding how the body functions is absolutely essential for modern medicine and thus embryonic stem cell research is worth pursuing if for no other reason than its academic value."

Calling research into fundamental aspects of how our bodies develop "dead-end" is pretty much a strong display of profound ignorance about modern medicine.

Re:What kind of stem cells? (1)

jgtg32a (1173373) | more than 4 years ago | (#29511873)

First time I've heard that, it looks like you're quoting something care to link it?

Re:What kind of stem cells? (1)

jgtg32a (1173373) | more than 4 years ago | (#29511863)

psst let me let you in on a little secret if it's an article about stem cells actually being used in some treatment they are adult stem cells

Existing Conditions? (3, Insightful)

BJ_Covert_Action (1499847) | more than 4 years ago | (#29509741)

The article states that the clinical trials are being conducted on patients with various levels of the disease. It also states that they are hoping to see the degenerative rate of the disease slow due to the treatments. It does not, however, talk about whether or not this stem cell treatment, or a similar one, could be used to treat patients with a developed case of ALS. For instance, to the /.er that talked about saving Hawking's life, Hawking has had the disease long enough that many of his motor neurons have probably already died out. Can this treatment be used to restore or replace said neurons? For those ALS patients that are already severely disabled, treatment needs to go beyond the stage of slowing the disease down. I would love to see ALS patients walking and talking again that couldn't previously.

Neuralstem's own website [neuralstem.com] also seems rather scant in details on therapy for highly developed levels of ALS. Does anyone know of any research being conducted to treat the latter stages of ALS or how relevant this treatment is for those stages?

Stem cells = Cancer (3, Informative)

sonnejw0 (1114901) | more than 4 years ago | (#29509757)

Stem cells have the potential to reproduce exponentially. Give these stem cells to a patient that has a mutation in growth factor production or secretion, like many cancer or precancerous patients, and you have an unmitigated tumor. I do research with growth factors and development. This, in my opinion, is not a good idea.
But those are the problems this research will address. I'll be eager to see the results in two years.

Re:Stem cells = Cancer (1)

jameskojiro (705701) | more than 4 years ago | (#29509903)

What they need is stem cells that grown in presence of a bio-compound not found naturally in the body. Give stem cells and drug them until stem cells are at the "just right" stage, stop taking the drug.

Re:Stem cells = Cancer (1)

sonnejw0 (1114901) | more than 4 years ago | (#29510263)

That's actually a great idea. An exogenous stem cell could be genetically engineered to intrinsically express a pro-apoptotic protein in an undifferentiated state while concurrently expressing a receptor that activates an anti-apoptotic protein. Inject the stem cells along with the signal that activates the receptor and the stem cells can proliferate until they differentiate. If they migrate outside the area that the signal is, the cells automatically die. If they do not differentiate, the cells automatically die. If the cells differentiate, they no long express the pro-apoptotic protein.
You're a genius, jameskojiro! Wish I had some mod-points to give you :-P

Re:Stem cells = Cancer (-1, Troll)

geekoid (135745) | more than 4 years ago | (#29510053)

Sonnejw0 = ignorant.

Please read up on the current state of stem cells. Something your not likely to understand if your homepage is any indication of your ability to think farther then two steps.

Re:Stem cells = Cancer (3, Informative)

sonnejw0 (1114901) | more than 4 years ago | (#29510199)

Excuse me, but ignorant is something I am not. I am a Neurobiology researcher working specifically on neurodegenerative diseases. Your Google profile to which you have linked in your signature suggests you're unemployed, at least that's what I take "futurist", "gamer", and "slashdot.org commenter" to mean. Failed IT career?

At any rate, stem cells have the potential to endlessly reproduce based on the presence of growth factors. Many forms of cancers and precancerous states are characterized by rapid and uncontrolled expression of growth factors. If a cancer patient with one of these common root causes is introduced to these stem cells, they suddenly will produce a massive tumour at the injection site. Which is exactly the concerns expressed by the research group that is doing this phase 1 safety trial, hence the need for a safety trial.

My research involves delivery methods for introducing growth factors that activate innate progenitor cells to replace cells damaged or lost in neurodegenerative diseases. There is a reason why there is only a miniscule fraction of progenitor and stem cells in the adult human body: because if there are a lot, there is a huge chance that one of these cells will either be mutated by environmental radiation, or a mutation of a nearby cell that causes it to dysregulate expression of hormone signals. It is an evolutionary adaptation to improve fitness.

My homepage is a list of concerns about current political and social trends. It obviously does not reach deep into every issue. I don't have the time to do that. You obviously think you're far superior to everyone else in the world, though, so why bother with me and my 'little' views. It seems that my opinions have so rattled you emotionally that you cannot possibly deal with it without being 'snarky' on the internet. Perhaps you could better spend your time by earning an income, or acquiring amicable social skills.

Re:Stem cells = Cancer (0)

Anonymous Coward | more than 4 years ago | (#29510545)

Oh, Snap!

Re:Stem cells = Cancer (1)

hemp (36945) | more than 4 years ago | (#29511429)

Your Google profile to which you have linked in your signature suggests you're unemployed, at least that's what I take "futurist", "gamer", and "slashdot.org commenter" to mean. Failed IT career?

and virgin.

Wait what? (1)

noundi (1044080) | more than 4 years ago | (#29510135)

we will see if doctors are willing to [use] it on subjects that have injuries coming from physical injuries like diving accidents.

First you have to convince crazy religious idiots, then you have to convince the crazy government idiots, and yet you still have to convince the crazy doctor idiots!? Is there no end to this insanity?!

Neural Stem Cell Therapy - It Tickles! (2, Funny)

abbynormal brain (1637419) | more than 4 years ago | (#29510357)

Neural Stem Cell Therapy - It Tickles!!! (tee hee .......eyes go glassy .... drool begins)

Sample Size? (2, Interesting)

JSBiff (87824) | more than 4 years ago | (#29510725)

Can someone who understands statistics and FDA trial phases explain something to me. . . Is a sample size of 12 really big enough to be a reasonable 'safety' trial? Or do they start with a small trial, just to find out if there's any problems so severe that they would affect almost *anyone*, then in future phases, increase the sample sizes to more and more test subjects, looking for those problems that only affect 1/1000 or 1/100000 patients?

W00T 7p (-1, Offtopic)

Anonymous Coward | more than 4 years ago | (#29511053)

Just a little late (0)

Anonymous Coward | more than 4 years ago | (#29511105)

My uncle had to go to China for a similar treatment - 5 years ago.

Maybe if he could've continued the therapy at home, he'd still be alive today.

embryonic or adult stem cells? (0)

Anonymous Coward | more than 4 years ago | (#29511851)

Doesn't say if they are using embryonic or adult stem cells. I don't approve of cloning and killing then harvesting cloned babies for spare parts. Its doubly wrong, if not then fuck yeah this shit rocks and I can't wait for the outcome!!!

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