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Implant for spinal cord (Karolinska institute, Sweden)

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  • #16
    They say that it is "a chronic, devastating condition leading to markedly impaired life quality and vey high economical costs to the scoiety" and yet the treatment is for acute stage only.

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    • #17
      Not encouraging news from anywhere for chronics.

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      • #18
        'Many years'? .. How 'many'?
        "It's not the despair, I can handle the despair! It's the hope!" - John Cleese

        Don't ask what clinical trials can do for you, ask what you can do for clinical trials. (Ox)
        Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature.

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        • #19
          Originally posted by GRAMMY View Post
          For now this is being designed for acute injuries. It will be many years before it reaches the chronic phase of development and testing.

          BioArctic Receives Grant from VINNOVA
          2012-04-03
          Today, VINNOVA announced that BioArctic Neuroscience AB was granted 3.5 million SEK for the clinical development of its proprietary
          product with the indication Treatment of Traumatic Spinal Cord Injury.
          VINNOVA is The Swedish Governmental Agency for Innovation Systems that supports research and development work of the highest quality.
          BioArctic is developing a new treatment for traumatic Spinal Cord Injury together with The Department of Clinical Neuroscience and
          Neurosurgery, Karolinska Institutet and Karolinska University Hospital.
          The product under development is a biodegradable device with a growth factor, which will promote and guide nerve growth in the spinal cord and restore function. During a neurosurgical procedure the injured spinal cord will be replaced by the product.
          Currently, there are 2.5 million victims suffering from Spinal Cord Injury, which is a devastating condition with loss of motor function and sensibility below the injured segment.


          There are no effective treatments for complete traumatic spinal cord injury, which is a chronic, devastating condition leading to markedly impaired life quality and very high economical costs to the society, says Dr. Pär Gellerfors, CEO of BioArctic Neuroscience.

          The company intends to develop the current product for "complete" acute spinal cord injury into the segment of "incomplete" spinal cord injuries and then eventually as a treatment for older injuries which is a 2.5 million patient market.


          Grammy,

          Thanks very much for posting this. It explains clearly that the company intends to start with complete acute spinal cord injuries and develop the product for use in incomplete acute spinal cord injuries and then for chronic spinal cord injury. They understand that the real market is the 2.5 million chronic spinal cord injuries.

          I suspect that the main reason they are doing it first in acute spinal cord injury is because these patients are being operated on anyway and this saves a great deal of the cost of the treatment for them. If they did a trial that required an elective procedure for chronic spinal cord injury and they had to pay for hospitalization and surgery, that would be a very expensive first trial.

          Wise.

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          • #20
            Originally posted by Wise Young View Post


            If they did a trial that required an elective procedure for chronic spinal cord injury and they had to pay for hospitalization and surgery, that would be a very expensive first trial.

            Wise.
            Wise,

            what you say is very questionable, in fact Stem Cell Inc. decided to focus on chronic SCI as they need fewer number of patients, they don't need to wait for people to get a proper SCI for the trial, they just recrute partecipants from all around the world etc. They are taking long time (probably too long) for safety reasons as set by the protocol they follow.
            Then they need just one center, no need for stardandization workshops etc..

            There are many rational examples to support the idea that doing a clinical trial on acute today is more expencive than a trial for chrnic SCI so that a company will be out of busyness before getting the therapy to people.

            Cethrin is an example that comes to my mind.

            How much would it cost today to run all the trials for methylprednisolone?
            Do you think you would have been able to complete the trials today before running out of money?

            Paolo
            Last edited by paolocipolla; 05-14-2012, 09:50 AM.
            In God we trust; all others bring data. - Edwards Deming

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            • #21
              Originally posted by topperf View Post
              'Many years'? .. How 'many'?
              @Topperf: Where they just received financing for the "development stage" of the product, it would only be my personal guess that it would be a minimum of a decade to bring the product to bedside according to their outlined intentions and everything going smooth with the science and funding available along the way. Who knows, the competition for this type of product will probably be quite fierce with so many others working on this particular strategy and the patient market standing at 2.5 million currently.
              http://spinalcordresearchandadvocacy.wordpress.com/

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              • #22
                I guess you're right, Grammy. - Well, I hope I might be able to participate in a trial, when/if they come around to that.
                And it's a plus that it's tried on acutes, by then - Still, I wouldn't have complained, if they had begun on chronics..
                Well - back to trying to stay alive in a meaningful way.
                "It's not the despair, I can handle the despair! It's the hope!" - John Cleese

                Don't ask what clinical trials can do for you, ask what you can do for clinical trials. (Ox)
                Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature.

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                • #23
                  topper F,
                  you said it just how I think it. Back to trying to stay alive in a meaningful way. Ugh!
                  Always good to see different research going on though.
                  www.symbolofstrength.com

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                  • #24
                    Originally posted by GRAMMY View Post
                    @Topperf: Where they just received financing for the "development stage" of the product, it would only be my personal guess that it would be a minimum of a decade to bring the product to bedside according to their outlined intentions and everything going smooth with the science and funding available along the way. Who knows, the competition for this type of product will probably be quite fierce with so many others working on this particular strategy and the patient market standing at 2.5 million currently.
                    "Never doubt that a small group of thoughtful, committed citizen can change the world; indeed, it's the only thing that ever has." Margaret Mead
                    Dennis Tesolat
                    www.StemCellsandAtomBombs.blogspot.com

                    "Change does not roll in on the wheels of inevitability, but comes through continuous struggle. And so we must straighten our backs and work for our freedom."
                    Martin Luther King

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                    • #25
                      Originally posted by topperf View Post
                      I guess you're right, Grammy. - Well, I hope I might be able to participate in a trial, when/if they come around to that.
                      And it's a plus that it's tried on acutes, by then - Still, I wouldn't have complained, if they had begun on chronics..
                      Well - back to trying to stay alive in a meaningful way.
                      The funding part isn’t so much of a hurdle in Scandinavia where one has a universal government paid health care system (social health care system). In fact governments over here have information courses and meetings for stimulating for clinical trials for therapies, that’s their goals. Thus, since this particularly trial is done in Sweden at the Karolinska Hospital, funding is available within the health care system and not so much of an obstacle. The trick is more which therapies to move forward into clinical trials, but one are working on that, also as seen from Sweden. Good thing the govt system, academia and private companies work together too. That’s key.

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                      • #26
                        I called Gellerfors who is involved in this research work. He says will start trial by the end of this year and if trial successful on acutes then within two years they will be doing trial on chronics.

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                        • #27
                          Thanks, Jawaid and Leif. I've written a letter to Gellerfors, of which I haven't received an answer yet, about participating in a trial - wish me luck.
                          "It's not the despair, I can handle the despair! It's the hope!" - John Cleese

                          Don't ask what clinical trials can do for you, ask what you can do for clinical trials. (Ox)
                          Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature.

                          Comment


                          • #28
                            At the surgery the damaged portion of the spinal cord is removed and replaced by the implant.

                            In just 14 days, new nerve fibers grows through the twelve channels running through the implant. This restore nerve function. The implant is then broken down by the body - leaving only the new nerve fibers.

                            It says that, "the implant is filled with a drug." Does anyone know what drug that would be?

                            And how will this be done without more gliosis and fibrosis entering the lesion area?

                            Research from the 1990s
                            In Bioarctic Neuroscience says CEO Pär Gellerfors:

                            "It is research that began in the early 90s at the Karolinska Institutet, where they tried to create a treatment for spinal cord injuries. The challenge was to know that the nerves and neural pathways in the brain do not grow out. The peripheral nerves are not the problem they actually regenerate. "

                            What kind of material he has no desire to say more than that it is' a biodegradable substance. " It has been degraded three or four weeks after it has been transplanted, in which the nerve fibers are re-established.

                            "This is the first time in the world that it happens,"

                            Does the clinical trials, as they should, the treatment can be ready in four to five years, the Pär Gellerfors.

                            The results were already published in Science in 1996.

                            It's the first time in the world that this is done, says Pär Gellerfors, CEO of BioArctic Neuroscience.

                            He says will start trial by the end of this year and if trial successful on acutes then within two years they will be doing trial on chronics.

                            It explains clearly that the company intends to start with complete acute spinal cord injuries and then develop the product for use in incomplete acute spinal cord injuries and then for chronic spinal cord injury.

                            These are perhaps points worthy of discussion and contemplation. Let's talk the realistic science, neurological aspects and current hurdles with known facts assuming Swedish funding and hopeful intentions are not an issue. We could start with their most recent paper in the spinal cord injury section of their website?


                            http://www.ncbi.nlm.nih.gov/pubmed/22124040
                            http://iospress.metapress.com/content/w224h6m176627652/fulltext.pdf (FULL ABSTRACT) !!!
                            FGF1 containing biodegradable device with peripheral nerve grafts induces corticospinal tract regeneration and motor evoked potentials after spinal cord resection.


                            Nordblom J, Persson JK, Aberg J, Blom H, Engqvist H, Brismar H, Sjödahl J, Josephson A, Frostell A, Thams S, Brundin L, Svensson M, Mattsson P.
                            Source

                            Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.

                            Abstract

                            PURPOSE:

                            Repairing the spinal cord with peripheral nerve grafts (PNG) and adjuvant acidic fibroblast growth factor (FGF1) has previously resulted in partial functional recovery. To aid microsurgical placement of PNGs, a graft holder device was previously developed by our group. In hope for a translational development we now investigate a new biodegradable graft holder device containing PNGs with or without FGF1.
                            METHODS:

                            Rats were subjected to a T11 spinal cord resection with subsequent repair using twelve white-to-grey matter oriented PNGs prepositioned in a biodegradable device with or without slow release of FGF1. Animals were evaluated with BBB-score, electrophysiology and immunohistochemistry including anterograde BDA tracing.
                            RESULTS:

                            Motor evoked potentials (MEP) in the lower limb reappeared at 20 weeks after grafting. MEP responses were further improved in the group treated with adjuvant FGF1. Reappearance of MEPs was paralleled by NF-positive fibers and anterogradely traced corticospinal fibers distal to the injury. BBB-scores improved in repaired animals.
                            CONCLUSIONS:
                            The results continue to support that the combination of PNGs and FGF1 may be a regeneration strategy to reinnervate the caudal spinal cord. The new device induced robust MEPs augmented by FGF1 and may be considered for translational research.

                            If the method enters a course toward a translational approach, irreversibly and completely devitalized spinal cord tissue would have to be removed, which demands an unambiguous diagnosis of complete spinal cord injury. (Steeves et al., 2010;
                            Zariffa et al., 2010).


                            (or here from Canada 2005)

                            http://www.ncbi.nlm.nih.gov/pubmed/15804055?dopt=Citation

                            J Neuropathol Exp Neurol. 2005 Mar;64(3):230-44.
                            Corticospinal regeneration into lumbar grey matter correlates with locomotor recovery after complete spinal cord transection and repair with peripheral nerve grafts, fibroblast growth factor 1, fibrin glue, and spinal fusion.

                            Tsai EC, Krassioukov AV, Tator CH.
                            Source

                            Toronto Western Hospital Research Institute and Krembil Neuroscience Center (ECT), University of Toronto, Toronto Western Research Institute, Toronto, Ontario, Canada.

                            Abstract

                            Knowledge of which tracts are essential for the recovery of locomotor function in rats after repair is unknown. To assess the mechanism of recovery, we examined the correlation between functional recovery and axonal regeneration. All rats underwent complete cord transection and repair with peripheral nerves, fibroblast growth factor 1, fibrin glue, and spinal fixation. Repaired rats recovered both motor-evoked potentials recorded at the lumbar level and locomotor function. Cord retransection rostral to the repair abolished the recovery, indicating improvement was due to long tract regeneration. To determine which long tracts correlated with recovery, a novel technique of simultaneous bidirectional axonal tracing and immunohistochemical examination of axonal type was used to quantitate the regeneration of corticospinal, rubrospinal, reticulospinal, vestibulospinal, raphespinal, propriospinal, serotonergic, and calcitonin gene-related peptide containing axons. Multiple linear regression analysis revealed recovery of function correlated only with regeneration of corticospinal axons into the gray matter of the lumbar spinal cord (R = 0.977, p < 0.02). For the first time, we show that regeneration of the corticospinal tract into the lumbar gray matter is a mechanism of functional locomotor recovery after complete cord transection and repair.

                            /forum/showthread.php?t=156823
                            Last edited by GRAMMY; 05-17-2012, 12:41 AM.
                            http://spinalcordresearchandadvocacy.wordpress.com/

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                            • #29
                              Originally posted by GRAMMY View Post
                              These are perhaps points worthy of discussion and contemplation. Let's talk the realistic science, neurological aspects and current hurdles with known facts assuming Swedish funding and hopeful intentions are not an issue. We could start with their most recent paper in the spinal cord injury section of their website?
                              ok, perhaps lets just start small at the beginning...

                              "At the surgery the damaged portion of the spinal cord is removed and replaced by the implant".

                              "If the method enters a course toward a translational approach, irreversibly and completely devitalized spinal cord tissue would have to be removed, which demands an unambiguous diagnosis of complete spinal cord injury". (Steeves et al., 2010; Zariffa et al., 2010).

                              "And how will this be done without more gliosis and fibrosis entering the lesion area where the scaffold breaks down so quick?"

                              "What is this damaged tissue? How do we know there aren't any healthy axons in there or spinal stem cells capable of regeneration or sprouting?"

                              There are many rational examples to support the idea that doing a clinical trial on acute today is more expensive than a trial for chronic SCI so that a company will be out of business before getting the therapy to people.
                              It explains clearly that the company intends to start with complete acute spinal cord injuries and then develop the product for use in incomplete acute spinal cord injuries and then for chronic spinal cord injury. If the "complete acute" cohorts don't show enough recovery, will the trial be abandoned? A complete acute is entirely different than a chronic.

                              How long will it take to recruit 24 freshly injured complete acutes when even these fresh injuries are told they could undergo substantial recovery without the risk of having their spinal cords cut out based on the theory that it worked ok on a rat? Slow recruiting?
                              Last edited by GRAMMY; 05-17-2012, 01:48 AM.
                              http://spinalcordresearchandadvocacy.wordpress.com/

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                              • #30
                                Grammy work looks good of Canada. Can this help in my lumbar injury? I think i can.

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