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  • skipping clinical trials?

    Im 21 years old, c6/c7 injury asia c and am curious about if it would be legal to skip clinical trials on certain treatments.
    I've been reading up on lv-chabc and isp treatments as well as pten deletion and growth hormone. My question is would it be possible to get my hands on the isp and lv-chabc for my own treatment along with rehab and possible estim. What would be the legality behind if i wanted to take these aproaches out of states to have the treatment done before they go through clinical testing. I fully believe in the isp and chondroitinase gene therapy possibly also combined with a stem cell transplant. Im just 8 months in and reading 24/7 about possible treatments with the patience of a 4 year old and desperate to have my life back

  • #2
    So the short answer is that it's possible - there is a thing called expanded access that allows trials and manufacturers to treat folks with the condition the drug is intended for outside the context of a trial (recent example is kids with some form of epilepsy being treated parallel to a clinical trial of a medical marijuana product). If the med isn't in human trials yet, it's still possible (folks were treated for Ebola with a number of drugs that were still in the development pipeline) but the criteria set are likely to be very stringent. If the med is already on the market, it's just a question of finding a doctor/facility willing to go off-label for you.

    All of that said, it's going to be hard to do. The layers of necessary institutional approval are many, and for researchers and manufacturers, the risk of extending access/providing compassionate use, especially of something early in the pipeline are high. Even if everything goes well for you but it turns out you need to continue that medication in perpetuity - if the med doesn't get to market and do well, they're not going to continue manufacture. There's been litigation about this in the past few years and IRB folks have said that based on the cost of litigation alone they will never again even listen to requests for extended access/compassionate use.

    The best chances would probably be to go abroad where the treatments are already in use or in parallel development and access care wherever that is.

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    • #3
      I think we as patients looking for treatments and a cure have to keep a global eye on everything. USA is not in the forefront of Bioscience, and we will probably have to go over seas to get treatment, and its gonna cost. Just my opinion

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      • #4
        I'm taking http://www.mod4all.com/zencart/index...&products_id=5

        I emailed Dr Jerry Silver. The information is documented so that it could be produced. If there is enough money to be made I'm sure someone will make it available. No one knows the correct dosage but I'm quite confident someone could make a reasonable guess. The US system seems to not really care to find a cure. The "foundations" I think are most content to milk donations from all the wonderful inspirational stories of those willing to work hard enough to be happy being crippled. I'm not happy being crippled. I wish you luck! Please find a way to bypass all this inspiration!

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        • #5
          Originally posted by andrew94 View Post
          Im 21 years old, c6/c7 injury asia c and am curious about if it would be legal to skip clinical trials on certain treatments.
          I've been reading up on lv-chabc and isp treatments as well as pten deletion and growth hormone. My question is would it be possible to get my hands on the isp and lv-chabc for my own treatment along with rehab and possible estim. What would be the legality behind if i wanted to take these aproaches out of states to have the treatment done before they go through clinical testing. I fully believe in the isp and chondroitinase gene therapy possibly also combined with a stem cell transplant. Im just 8 months in and reading 24/7 about possible treatments with the patience of a 4 year old and desperate to have my life back
          You shouldn't consider any treatment until injured for 2 years. Your body is still healing and recovering naturally.
          Intense rehab is what you should be doing now.

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          • #6
            Good advice above.
            Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

            T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

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            • #7
              I wonder if it's possible to get the same spinal stimulation therapy that is being done here in the US
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              • #8
                Originally posted by andrew94 View Post
                Im 21 years old, c6/c7 injury asia c and am curious about if it would be legal to skip clinical trials on certain treatments.
                I've been reading up on lv-chabc and isp treatments as well as pten deletion and growth hormone. My question is would it be possible to get my hands on the isp and lv-chabc for my own treatment along with rehab and possible estim. What would be the legality behind if i wanted to take these aproaches out of states to have the treatment done before they go through clinical testing. I fully believe in the isp and chondroitinase gene therapy possibly also combined with a stem cell transplant. Im just 8 months in and reading 24/7 about possible treatments with the patience of a 4 year old and desperate to have my life back
                @andrew94
                I agree with Jim. You have some natural healing that will be taking place over the coming months since you're only 8 months out on this and should be working hard to regain as much as you can.

                Optimization of the intracellular sigma peptide (ISP) for SCI treatment are underway in the lab but it takes time to work it out to find the correct and best concentrations and delivery paradigms for the vast majority of people that will be getting the therapy. It will go through human clinical trials to test for safety and efficacy as the other treatments that are working their way to the clinic. We do not know if the lv-chase will be selected to go forward or if it will be direct delivery. Much will be learned and decided upon once the data is completed on the canine trials. Currently there is no lenti-virus available for distributing Chondroitinase. PTEN deletion is still at a very young basic research science stage but is working it's way forward also. No gene knockdown therapies such as this are available. The transcutaneous and subcutaneous stimulators are in testing and development stages also. There are several different legitimate biotech companies with stem cells in clinical trial that are working hard to find the best cells to help with regeneration at all different stages of SCI. These other items you mention are not readily available on a black market anyway (legal or illegal). You are indeed watching some of the most exciting research in the SCI field that may ultimately work into combo therapies. I commend you for reading and learning about the important science and research going on! The next step will be to learn how the research works forward with biotech investment along with sanctioned human clinical trials and FDA regulations. I'll be putting a new video with the FDA on the blog tonight.

                Your injury is very new and unfortunately we know how exasperating that feels. I would avoid the black market and overseas stem cell clinics that will clean out your pocket book and inject who knows what kind of snake oil into you. Best of luck Andrew!

                https://spinalcordresearchandadvocacy.wordpress.com/2012/02/27/sci-stem-cells-snake-oil-and-serious-hope-keith-tansy/
                Last edited by GRAMMY; 11-29-2015, 10:43 PM. Reason: added information
                http://spinalcordresearchandadvocacy.wordpress.com/

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                • #9
                  Originally posted by Dlevy View Post
                  I'm taking http://www.mod4all.com/zencart/index...&products_id=5

                  I emailed Dr Jerry Silver. The information is documented so that it could be produced. If there is enough money to be made I'm sure someone will make it available. No one knows the correct dosage but I'm quite confident someone could make a reasonable guess. The US system seems to not really care to find a cure. The "foundations" I think are most content to milk donations from all the wonderful inspirational stories of those willing to work hard enough to be happy being crippled. I'm not happy being crippled. I wish you luck! Please find a way to bypass all this inspiration!
                  I hear you, being crippled blows. are you taking this stuff currently or will in the future? If so any effect?

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                  • #10
                    I've been taking it about a week. I don't have any specific progress but I do feel a bit different. I have had two migraines in the past week but I had two in the previous few weeks. I normally have one migraine a year for the past 20 years. Something is going on there but I think it's the SCI. I am 27 months into my injury.

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                    • #11
                      Offer a couple mill as a "donation" you'll get in donate your damaged cord too.

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                      • #12
                        Originally posted by Dlevy View Post
                        I've been taking it about a week. I don't have any specific progress but I do feel a bit different. I have had two migraines in the past week but I had two in the previous few weeks. I normally have one migraine a year for the past 20 years. Something is going on there but I think it's the SCI. I am 27 months into my injury.

                        I just wanted to give my personal experience with migraines. I don't know if it was because of natural recovery but every time I had a headache afterwards some function/sensation returned to me. Not sure, maybe it was a coincidence but I experienced that...

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                        • #13
                          Wow, that is my experience. Thank you so much for taking the time to share that information. I had five migraines in a few weeks. I got on topomax and the headaches stopped. I am also on 4-AP. My nerve pain is tremendously lessened and I have increased function. For the first time since my injury (2 years) my pain level is tolerable and I am off opioids! Sometimes I have no pain. I have no side affects from the 4-AP. I am only taking 5 mg twice a day. It looks like the 4-AP source has stopped shipping so I am trying other methods of acquisition. Your comment makes me question if my improvement is a natural coincidence to taking 4-AP.

                          I don't really care what is causing the reduction in pain I just want it to continue. Nerve pain is a living hell and opioids don't help much.

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                          • #14
                            Originally posted by wesmaister View Post
                            I just wanted to give my personal experience with migraines. I don't know if it was because of natural recovery but every time I had a headache afterwards some function/sensation returned to me. Not sure, maybe it was a coincidence but I experienced that...
                            Scientists in Mozambique found a natural alternative;



                            Sorry, couldn't resist. Merry Christmas
                            .
                            "Talk without the support of action means nothing..."
                            ― DaShanne Stokes

                            ***Unite(D) to Fight Paralyses***

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                            • #15
                              Lol, this is the new standard scientific approach to treating SCI. The foundation is accepting funds RIGHT NOW! The greenery is so inspiring and the water lubricates our return to society. That was awesome.

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