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UCSD To Test Safety of Spinal Stem Cell Injection

samzenpus posted about a month ago | from the learning-to-walk-again dept.

Medicine 43

An anonymous reader writes Researchers at the University of California, San Diego School of Medicine have launched a clinical trial to investigate the safety of neural stem cell transplantation in patients with chronic spinal cord injuries. This Phase I clinical trial is recruiting eight patients for the 5-year study. Pre-clinical studies of these cells by Ciacci and Martin Marsala, MD, at the UC San Diego School of Medicine, showed that these grafted neural stem cells improved motor function in spinal cord injured rats with minimal side effects indicating that human clinical trials are now warranted.

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Worst that could happen? (4, Insightful)

TWX (665546) | about a month ago | (#47667491)

A teacher of mine was a quadriplegic, minor arm movement, but no fingers/hands, and nothing in the lower half of his body.

Beyond this treatment actually sickening and/or killing the patient, what is the worst that could happen, from a safety point of view? I know that's in-part the point of the study, but many of those individuals that are this badly injured (or worse, no motion below the neck would probably gladly trade the risk of death for getting their bodies to work again.

Re:Worst that could happen? (1)

Intrepid imaginaut (1970940) | about a month ago | (#47667519)

Primum non nocere.

Re:Worst that could happen? (2)

agm (467017) | about a month ago | (#47667935)

Nullum est periculum mercedem non.

Re:Worst that could happen? (1)

Intrepid imaginaut (1970940) | about a month ago | (#47668109)

Festinare nocet, nocet et cunctatio saepe, tempore quaeque suo qui facit, ille sapit.

Re:Worst that could happen? (0)

Anonymous Coward | about a month ago | (#47668235)

Lorem ipsum dolor sit amet, consectetur adipiscing elit.

Re:Worst that could happen? (1)

ColdWetDog (752185) | about a month ago | (#47668373)

Romanes Enut Domus.

Re:Worst that could happen? (0)

Anonymous Coward | about 1 month ago | (#47668575)

People called Romanes they go the house?!

Re:Worst that could happen? (1)

citizenr (871508) | about a month ago | (#47668243)

fellate mea pullus
also Romanes eunt domus

Re:Worst that could happen? (0)

Anonymous Coward | about 1 month ago | (#47668823)

Anglicus placere, nec latina

Re:Worst that could happen? (0)

Anonymous Coward | about 1 month ago | (#47669107)

Domine mi, tu es cunnus stultum. Sed te ipsum.

Re: Worst that could happen? (1)

Anonymous Coward | about a month ago | (#47667523)

Death. Rejection of the stem cells. Chronic central nervous system pain they might not have had prior. (My brother in law participated in a similar trial for ALS earlier this year, and I read the informed consent doc.) It's a tough decision about whether to participate or not -- hats off to those subjects who are willing to.

Re: Worst that could happen? (0)

Anonymous Coward | about a month ago | (#47668383)

A friend/neighbor got excited about a news article that ballyhooed a treatment for Parkinson's that was being done in China. It purported to use retinal stem cells injected into the appropriate brain center. As he was in advanced Parkinsonism, he and his wife shelled out the money and flew to China for the treatment. Months later, he returned, spent weeks in an ICU and more in a convalescent hospital, much worse off than when he went. Neither of the Chinese docs had ever published on Parkinsonism or were even neurologists...just saw a money opportunity and took it. They lined up a shill for the newspaper article who claimed to have been totally disabled but was now riding a horse and doing pretty much everything. I expect the UCSD docs are a cut above these guys and will provide much better care, but bad things can happen and do, even with investigational review boards and human subjects protections. These projects are only for the truly desperate cases...all others better wait and see.

Re: Worst that could happen? (1)

Shortguy881 (2883333) | about 1 month ago | (#47671149)

You are comparing outright fraud with medical research. Just FYI, they are not the same thing.

Re:Worst that could happen? (1)

mythosaz (572040) | about a month ago | (#47667527)

Was your question, "Beyond something bad happening to them, what bad things could happen to them?!?"

It's a difficult question. Risk what little motor control you have left (fingers you say?) in a gamble to get some more (or all) back.

I'd roll the dice, but I'm not sure everyone would.

Rolling....1....fumble!

Re: Worst that could happen? (0)

Anonymous Coward | about a month ago | (#47667551)

Cancer.

It's really the only drawback to stem cell use. Sometimes those new cells have trouble figuring out why their age is different than their neighboring cells and decide to become immortal.

But cancer can happen to anyone anyway. If the choice is between paralysis and accompanying health problems vs improved (or complete) function with a possibility of a shorter life, I'd agree. Why not?

Re: Worst that could happen? (1)

TWX (665546) | about a month ago | (#47667601)

Cancer.

Ah. The elephant in the room that I obviously ignored too.

Re: Worst that could happen? (1)

Gr8Apes (679165) | about a month ago | (#47667923)

Cancer is genes gone bad, more or less. Good stem cells can develop into cancer, but that's no more likely than their neighbors. I'd be a volunteer if I were in that position, because to me death or improvement would both be desirable in comparison to the GP posed situation. Others will most likely have different opinions.

Re: Worst that could happen? (0)

Anonymous Coward | about a month ago | (#47668337)

The treatment would likely result in some inflammation at a site where there had been plenty of damage already. Inflammation is induced by tissue damage and results in reactive oxygen species (ROS), which increases DNA damage of surrounding tissue (increasing the chances of cancer).
On the other hand, the patients will likely undergo immunosuppressive therapy (unless the stem cells are patient derived) which will decrease immune survailance and increase the chances of cancer throughout the body (the immune system usually catches cancer very early).
It is easy to make the decision when you have nothing to lose (in a hypothetical situation) or when you can ignore the effect it will have on those around you (if anyone likes you). That being said, I'd probably volunteer if the science looked good (I'd have to see the pre-clinical data, but maybe not since it seems it was first developed for ALS). This reminds me both you and I should probably fill out a Advance Health Care Directive (https://en.wikipedia.org/wiki/Advance_health_care_directive) in case we become severly disabled (unable to finish the job) since the law won't allow assistance (at least in the US).

Re: Worst that could happen? (0)

Anonymous Coward | about 1 month ago | (#47668801)

"The treatment would likely result in some inflammation at a site where there had been plenty of damage already. Inflammation is induced by tissue damage and results in reactive oxygen species (ROS), which increases DNA damage of surrounding tissue (increasing the chances of cancer).
On the other hand, the patients will likely undergo immunosuppressive therapy (unless the stem cells are patient derived) which will decrease immune survailance and increase the chances of cancer throughout the body (the immune system usually catches cancer very early)."

What are the numbers (at least lower/upper bounds) for any of this? How many ROS molecules are created, how much DNA damage per molecule, how much damage per percent increase in cancer rate, etc? I bet they don't exist even for the most common animal models. Theories based on lists of factors that increase/decrease something are weak, be careful.

Re:Worst that could happen? (0)

Anonymous Coward | about a month ago | (#47667617)

I think they're just taking it slow so that fundies can't tack "RAMPANT" onto their claims of "PLAYING GOD" and "BABY KILLING".

Re:Worst that could happen? (1)

Hamsterdan (815291) | about a month ago | (#47667771)

Agree.

If I was in that situation, I would think exactly the same way. Seriously, is death worse than not being able to move?

Re:Worst that could happen? (2)

Stickerboy (61554) | about a month ago | (#47667893)

Worst that can happen? Well, since this is basically a roll of the dice as to what happens?

Pain originates as nervous system signals. Wouldn't it be great to permanently switch the pain centers to on in these quadriplegics with no recovery of motor function? And someone else already brought up cancer.

Don't ask, "Well, how can it possibly get worse?" Because it can always get worse.

Re:Worst that could happen? (4, Informative)

Mashiki (184564) | about a month ago | (#47668137)

I'm guessing you don't have a spinal cord injury, because if you did then you'd be happy with just about anything that could improve it. Since in a lot of cases, those pain centres are already "on." I'm still debating on getting a baclofen pump, that dumps the crap right into my spinal fluid. I already passed on the spinal fusion, since the failure rate and chance of being a paraplegic or parapligic was 53%

As for worse? Well death is always a possibility too, but we're already heading down that road. The only question is when you get there and how.

Re:Worst that could happen? (4, Insightful)

currently_awake (1248758) | about a month ago | (#47667921)

You might prevent a future treatment that actually works. I believe that horribly injured/dying with no cure possible should be allowed to "experiment" with anything that has the slightest chance of working, with informed consent.

Recommended music during the operation (3, Funny)

ArcadeMan (2766669) | about a month ago | (#47667561)

Spinal Tap

Re:Recommended music during the operation (1)

msauve (701917) | about a month ago | (#47668157)

But this one goes to 11.

Re:Recommended music during the operation (0)

Anonymous Coward | about 1 month ago | (#47669341)

Somebody mod this to 6.

Fingers crossed (1)

Dorianny (1847922) | about a month ago | (#47667645)

Lets hope this trial ends better than that of the poor woman who had tissue containing olfactory stem cells taken from her nose and implanted in her spine, and 8 years later had to have surgery to remove the nose that grew on her back!

Re:Fingers crossed (0)

Anonymous Coward | about a month ago | (#47667837)

Does your nose run and your feet smell? You were built upside down!!!

Quoted from Mad Magazine joke, 40 years old now?

Re:W00t fp!? (-1, Flamebait)

Barack Nigama (3779375) | about a month ago | (#47667983)

Oh. My. God. I want so badly to stick my fetid cock deep inside your rancid Bayer Aspirin hole. I can see the worms from the shit seeping from your Bayer Aspirin hole getting erect so that they can mate with the worms squirting from my fetid cock.

What say you?

Why will the slashdot community not allow me this simple request? What has the world come to when a man cannot place his fetid cock into the spread-wide anus of another man?!?!

This all started when samzenpus denied me entry into his rancid recutm. I created a slashdot account. My goal was to post karma whoring statements of linux superiority and post lmgtfy links. I was supposed to achieve the +3 posting bonus before I began my trolls.

But...

But.... ....

But I could not help myself... samzenpus broke my heart. I require worms deep inside my urethra.

What say you?

What say you???

What say you?????

WHAT SAY YOU?!?!?!?!?!?!?!?!?!?!?

Another Trade Vanishes (3, Insightful)

Jim Sadler (3430529) | about a month ago | (#47667909)

Just imagine if we can fix spinal cords how many layoffs will occur in the wheel chair industries!. And home health aids may be less in demand as well as many people confined to chairs need a lot of help in the homes. This is one time that technology replaces workers that the world can rejoice and even giving more hope to the injured is in itself so vitally important. Now if we could just find a way to eliminate funeral workers -----

Re:Another Trade Vanishes (1)

currently_awake (1248758) | about a month ago | (#47667991)

I hear (rumour) that the (known to work) cure for diabetes won't be available ever because it would cost too much money from lost drug sales.

Re:Another Trade Vanishes (0)

Anonymous Coward | about a month ago | (#47668141)

That super expensive Hep C medicine has shown that you can have an overpriced miracle cure and make a ton of money.

Besides, with a cure for diabetes we could keep drinking Mountain Dew like water. I think the entire junk food industry would gladly pay the pharmaceutical industry to make up for lost sales.

Re:Another Trade Vanishes (1)

Dorianny (1847922) | about a month ago | (#47668453)

That super expensive Hep C medicine has shown that you can have an overpriced miracle cure and make a ton of money.

What they demonstrated is that by overpricing a miracle cure you can effectively limit its use and keep it from lowering the the infection rates, thereby safeguarding the drugs future profits, all while making insane amounts of profit.

Re:Another Trade Vanishes (1)

ColdWetDog (752185) | about a month ago | (#47668387)

Right. Because the US fee-for-service medicine model is the only one on the planet and furthermore, US pharmaceutical firms and scientists are the only ones who could possibly do breakthrough level science.

Expand your horizons. There is a large, very sophisticated world out there.

Re:Another Trade Vanishes (0)

Anonymous Coward | about 1 month ago | (#47669513)

Technically a pancreas transplant is a cure for type 1 diabetes.

Re:Another Trade Vanishes (1)

Mashiki (184564) | about 1 month ago | (#47670797)

Would that be the islet transplants? Because sure they do work, the only problem is about 70% of the people end up back on some dosage insulin because the body starts killing them again. The worst cases they're right back to the beginning 10 years down the road. There's still some fine tuning to fix it, my sister was offered to be in the very first round of clinical trials at sick kids london(Ontario) that was just about 20 years ago now, she opted for the clinical trials of the insulin pump though and I think she ended up being the 8th or 9th in Canada to use it.

Re:Another Trade Vanishes (0)

Anonymous Coward | about a month ago | (#47668497)

"eliminate funeral workers"
If someone ever discovers a way to seriously pro-long lifespans, say 30 to 50 years, the world would destroy itself in record time. Older generations need to fade away to make room for the younger generation. Every problem the world faces today are ultimately caused by overpopulation and it is only going to get worse. Natural resources are finite and as the population grows those resources will decline faster. More people add more stress on the environment to the point it would become unrecoverable no matter how much effort is made to preserve it. More people means overcrowding and with the latent thirst for conflict and violence already hardwired into our genes will increase violence around the world and ultimately end up in non-ending global wars. It will most likely be these endless violence and wars that will alleviate the overpopulation problem in a quick and brutal fashion.

Upbeat about this trial (4, Informative)

tpjunkie (911544) | about 1 month ago | (#47668581)

I own stock in the company conducting the trial (AMEX: CUR), and this phase I study is really more of a formality, as they have finished injections in the cervical and lumbar spine for a phase IIB study using the same stem cells in ALS patients; thus far the safety profile has been excellent (efficacy hasn't been rigorously looked at yet, but the initial results are promising). The results in rat models for spinal cord injury were very impressive, if this stuff translates it'll be a real game changer...I've read most of their published data so far and everything looks legit.

I've had this procedure preformed on me (0)

Anonymous Coward | about 1 month ago | (#47670117)

Several weeks ago, a doctor preformed this procedure on me to try and treat herniated disks in my lower lumbar. While I have experience a slight reduction in pain, it still is unbearable to sit for for than a very short period of time. I am hoping with time my back will keep healing and experience decreased pain levels.

Should be pointed out... (1)

RailGunner (554645) | about 1 month ago | (#47670457)

... that this test, much like the procedure done for Texas Gov. Rick Perry a few years ago, involves adult stem cells, and not embryonic stem cells.

Insensitive Clods (0)

Anonymous Coward | about 1 month ago | (#47671287)

Reading the various posts is amazing. They can be summarized as "there are things worse than death". Maybe, but it isn't a spinal cord injury or disease nor birth defect.

I have a spinal cord injury and now interact with people with spinal cord injuries. We don't look for the release of death. I just finished my third RAGBRAI (http://www.RAGBRAI.com). What did you doi with your body in July? We are working on a plan for a C6 complete tetraplegic to do the RAGBRAI next year.

Check out the achievements of the clients of Be Extraordinary (www.Be-X.org). They are amazing.

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