FDA Approved MS Stem Cell Trial Needs Your Help

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FDA Approved MS Stem Cell Trial Needs Your Help

Postby marcstck » Tue Mar 18, 2014 8:09 pm

The FDA has so far approved only two MS stem cell trials, and one of them is attempting to fund their research via the crowdfunding site Indiegogo. The Tisch MS Research Center of New York is about to start a 20 person trial using nervous system specific stem cells (derived from mesenchymal stem cells extracted from the bone marrow of trial subjects) in an attempt to repair MS damage to the central nervous system. The center is a registered nonprofit organization, and has spent years researching and refining their methodology. After multiple failed attempts at getting FDA approval, they finally received the FDA go ahead in August, 2013.

Here's a link where you can read all about the trial, and get specifics on how to help:

http://www.wheelchairkamikaze.com/2014/ ... needs.html

Thanks in advance for whatever help can be provided…
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Re: FDA Approved MS Stem Cell Trial Needs Your Help

Postby brm » Wed Mar 19, 2014 10:39 am

Sounds very interesting, they've got my support!
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Re: FDA Approved MS Stem Cell Trial Needs Your Help

Postby centenarian100 » Wed Mar 19, 2014 9:07 pm

good post Marc. I definitely have my eyes on this project. It's an open label phase I safety trial, but they have some good secondary outcome measures which might give us a hint about efficacy

Here is the clinicaltrials.gov link:

http://www.clinicaltrials.gov/ct2/show/ ... sis&rank=1

I like their inclusion criteria because they try to focus on non-relapsing MS. Hopefully, they can get a lot of people with EDSS >/= 6.5 into the trial
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Re: FDA Approved MS Stem Cell Trial Needs Your Help

Postby David1949 » Fri Mar 21, 2014 2:38 pm

Its well worth contributing to. They only need $300,000. There are 300,000 MRers in the usa so it works out to a buck a piece. Thats definitely a bargain.

Marc
Thanks so much for posting this. Win or lose you will not lose my confidence. You have been a great advocate for those of us who are afflicted by this monster. BTW you aren't crazy for suspecting that the pharmaceutical companies might put the bottom line above the interests of patients. At least if your crazy I have the same kind of crazy, and I'm a capitalist!
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Re: FDA Approved MS Stem Cell Trial Needs Your Help

Postby marcstck » Sat Mar 22, 2014 10:49 am

Thanks for the encouragement and support, folks. Much appreciated.

David, for the record, I'm a capitalist also! The pharmaceutical companies do engage in some questionable business practices (bribing doctors, suppressing negative research results), but for the most part they simply do what public companies are supposed to do, make every effort to enhance shareholder value. Towards that end, the research they fund is directed towards projects that have the potential to evolve into very profitable ventures. Just this week I spoke with a prominent MS researcher who was very concerned because he MS drug market has become quite saturated, and big Pharma is pulling back from MS research because there's not much room left in the market. This could be catastrophic for research into multiple sclerosis.

The problem lies not with the pharmaceutical companies themselves, but with our research model, which has evolved to rely heavily on pharmaceutical company funding for all kinds of medical research. As the federal government cuts back on research funds, the model grows even more lopsided. At this point, the dysfunction is baked into the system, and is perpetuated by decent people simply doing the best jobs they can. This is highly problematic, and only getting worse…
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Re: FDA Approved MS Stem Cell Trial Needs Your Help

Postby centenarian100 » Sun Mar 23, 2014 7:56 pm

marcstck wrote:Just this week I spoke with a prominent MS researcher who was very concerned because he MS drug market has become quite saturated, and big Pharma is pulling back from MS research because there's not much room left in the market. This could be catastrophic for research into multiple sclerosis.


I must admit that my family is part of the problem here because we have accepted unproven and likely ineffective drugs in progressive MS.

We are basically rewarding drug companies for good marketing rather than for good research. If you are a pharmaceutical company, what is the point of investing hundreds of millions of dollars in new progressive MS research if idiots like me are willing to accept $50,000/year ineffective drugs [by proxy].

...but lets take it the other way around. Lets say there was nationalized healthcare, and the US government refused to pay for any disease modifying therapy, approved or experimental, for non-relpasing progressive MS. You and I would be furious! However, the government would be right in the sense that this decision would not only save money but also would motivate pharmaceutical companies.

Let me phrase it another way. Lets say that you are biogen. What is easier?

1) convincing [via clever marketing] a 65 year old with progressive MS for the last 25 years with no new or enhancing MRI lesions or clinical relapses for the last 25 years to take avonex/tysabri/tecfidera

2) Developing a groundbreaking drug that remyelinates, prevents axonal/neuronal degeneration and proving that it works in two expensive phase III trials

I think the answer is obvious.
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Re: FDA Approved MS Stem Cell Trial Needs Your Help

Postby HarryZ » Mon Mar 24, 2014 6:16 am

The problem lies not with the pharmaceutical companies themselves, but with our research model, which has evolved to rely heavily on pharmaceutical company funding for all kinds of medical research. As the federal government cuts back on research funds, the model grows even more lopsided. At this point, the dysfunction is baked into the system, and is perpetuated by decent people simply doing the best jobs they can. This is highly problematic, and only getting worse…


Unfortunately, the research model was developed by the pharmaceutical companies.

Most promising discoveries for MS treatments start in the grass roots research area in universities or centers affiliated with universities. If a drug company sees potential large profit in such a treatment they purchase the rights to it from the university and then patent it. Next comes the trials and if relatively successful (using the data to show the drug works for MS patients), the marketing and sales after FDA approval.

It's the efficacy level of the drug that gets manipulated because that will determine how much the market will pay for such a treatment. And if needed, the drug company will do a head-to-head trial against a competitors drug to try and gain that all important extra percentage or two share of a very large and lucrative market.

The cost of these drugs is also artificially kept high (interferons developed in the early 90's cost far more now than they did back then) because nobody can generically produce them after so many years.

So what we have is a very protected market of drugs that are minimally effective for MS and due to the revenue $$$ available, we have multiple players trying to cash in creating a saturation.

And if you are a company or organization that isn't developing a treatment for MS that involves drugs, just try and get funding from anyone in today's tight money environment.
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