FDA OKs First Human Trial of Neural Stem Cell Therapy

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."

Dr. Stephen Hawking

[Anonymous Coward]

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

Big News?

[lobiusmoop]

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

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[account_deleted]

Comment removed based on user account deletion

Re:Wonder how this will cost

[Anonymous Coward]

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

[Anonymous Coward]

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?

Existing Conditions?

[BJ_Covert_Action]

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?

Re:Big News?

[geekoid]

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

Re:Big News?

[PopeRatzo]

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

Re:Big News?

[geekoid]

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:What kind of stem cells?

[BlueParrot]

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?

[interkin3tic]

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.

Corporations

[bobbuck]

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:Dr. Stephen Hawking

[Bruce Perens]

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

Re:Big News?

[Bruce Perens]

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.