New ALS stem cell trial approved by FDA

[Big Mike]

http://http://www.pharmalive.com/News/index.cfm?articleid=678477&categoryid=21

FDA Gives TCA Cellular Therapy Green Light to Proceed with First ALS Adult Stem Cell Trial Using Patient's Own Stem Cells

COVINGTON, La.--(BUSINESS WIRE)--Jan 13, 2010 - TCA Cellular Therapy, LLC (TCA-CT) announced today that the U.S. Food and Drug Administration (FDA) has approved its adult stem cell protocol to conduct Phase I clinical trials to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease).

This is the second FDA-approved protocol for the treatment of ALS using stem cells in the country; and the first using adult stem cells from the same patient. The aim of the Phase I study will assess safety.

ALS afflicts approximately 30,000 Americans. More people die of ALS than Huntington's disease; and the fatalities nearly equal Multiple Sclerosis. The life expectancy of a patient diagnosed with ALS is two to five years.

“I hope that our trial, along with the combined efforts of scientists and patients, will pave the way to breaking the chains of this devastating disease,” stated Gabriel Lasala, M.D., president and CEO of TCA Cellular Therapy.

About the Trial

Under the scientific guidance of cellular biologist, Jose J. Minguell, Ph.D., the adult stem cells will be taken from the patient's bone marrow in a simple outpatient procedure. The cells will then be processed in TCA-CT's GMP laboratory and administered to the patient by spinal tap in one of TCA-CT's facilities.

Recruitment for trial patients will commence in the next few weeks. The company anticipates moving into Phase II within a year.

About TCA Cellular Therapy

TCA Cellular Therapy, a privately-held company located in Covington, Louisiana, has assembled a team of neurologists, neurosurgeons, cell biologists, and pathologists to study some of the most debilitating neurological diseases including ALS and Spinal Cord Injuries.


Contact: TCA Cellular Therapy
Gabriel Lasala, M.D., 985-867-4860
[email protected]
Stem Cell Research | Covington | Adult Stem Cell Banking

 

[peter57]

It seems things are moving along, hopefully somthing will come out of all these trials soon for us but i expect stem cell treatment is still a little way off, I hope i am wrong.

cheers
peter

 

[asantiago]

From the article it sounds like the same treatment my mom received in Germany.

 

[jmccarty]

I'm curious to see what they are planning in terms of any modifications/selections to the marrow cell population. I've called as well as written to ask that and some other questions; I'll let folks know if they respond.

Asantiago – can I ask how was your mothers experience? I'm presuming this was the X-cell Center. How was the clinic and has she been able to determine any benefit?

 

[asantiago]

Yes it was the Xcell Center. The clinic was great, the result not so much. She had the treatment in December one month after diagnosis and passed away 3 months later. She saw zero benefit from it. The number of cells they harvested was much much lower than they like to use for the treatment which they said is common with ALS patients to have low stem cell counts. I've written to the clinic a few times and asked them to either update their statistics on ALS treatment results or remove it from the list of diseases treated. At the time, there were 4 other US patients with ALS that had sought treatment and none of them realized any postive affects from it.

The clinic was very honest and upfront with us about the fact it was very likely the treatment would not help her it was more of a hope that it would slow progression which it obviously didn't.

 

[Erica]

Dr.McCarty,
What do youthink of the Monterey/Mexico Stem Cell program?
Thank you, Erica

 

[Big Mike]

Hi Dr. McCarty,

Do you think they are planning to differentiate the bone marrow cells into neural cells? I can't imagine they would just use undifferentiated cells.

Thanks,
Mike

 

[jmccarty]

Hi,
I'd be happy to give some impressions – I can also direct you to a thread where this I made quite a few posts on this topic when I was working at TDI. I'm giving the link to the end of the thread and suggest you work backwards a ways as this was an example of one of those threads which get way 'off-topic' in the middle but alls well that ends in a reasonable discourse: Stem Cell Scares - ALS Research & Treatments - ALS Forum

I'll give an abbreviated analysis here: in a nutshell, my impression is that what they are doing in some sense is probably on par with what is being done in a number of private clinics or even perhaps trials in planning. The approach specifics are somewhat novel as they are selecting cells from the blood with a specific marker on the surface and re-injecting n this case in the base of the brain. All, so far, well and good as can be: in some sense very primitive in that the cells are not being engineered, for example, but much of that is in response to the very early state of knowledge in stem cells and the need to work with cells sourced autologously (from self), presumably given concerns on immune rejection.

What does give me some pause, however, are the claims – they publish that it can slow progression based on very small numbers of patients and using techniques for that determination that are not at all accepted for such and which I would have strong doubts could provide a reliable metric.

An additional point, Mike has raised, would be on whether these specific cells would be capable of generating neurons (presumably post implantation) as is presumed: my impression is this would not be yet a solid assumption among cell biologists. There also does not appear to be any attempt to differentiate them so in the test tube: the protocol that is published is simple isolation followed by resuspension in patient CSF for injection.

 

[*ENV*]

For contrast, the Neuralstem product is already diff'd to neural which should help. It's not autologous though.

One thing to bear in mind is that even if a cell turns into a neuron with a 3 foot axon, if it doesn't go the final micron and form an NMJ with a muscle fiber it doesn't matter.

I am hopeful about Nstem but that is because I don't know any better...