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Thread: Dr. Jan-Eric Ahlfors pushes forward with Regeneration Matrix

  1. #51
    Quote Originally Posted by Jan-Eric Ahlfors View Post
    Hi,
    I had to register again and thanks for inviting me. Wise Young is correct -- I have good connections with neurosurgeons in Russia and it is A LOT cheaper to do clinical trials there. Canada likes to follow the FDA, and prefers to give clinical trial approval after the FDA has already done so, making it almost easier to start clinical trials in USA than Canada esp. for new types of products and treatments. So there was limited value and too expensive to start off in Canada, although I do plan to do a clinical trial in Canada at some point. We have recently started working on opening another clinical site in one or two countries in western europe thanks to strong interest by neurosurgeons there, but this will of course take the standard many months of paperwork etc.
    Thanks for answering doctors. But I definitely see what you're saying, and I think that's why we have no clinical trials in Canada. Now this biocompatible matrix (biomatrix) Is like a scaffold technology correct? So does that mean it will make the injury site more habitable for the cells? As well as keep them fixated at the injury?

    And just a rough estimate if you could, how much who it take to have your or a similar clinical trial in Canada?

  2. #52
    We did not run a full budget cost analysis for running a clinical trial in Canada, but I can tell you that NeuralStem Inc.'s ten patient SCI clinical trial in Switzerland is costing them $10 million (so $1 million per patient!). The cost in Canada for acute patients would be lower (but still several million $ for just 10 patients) as Canadian hospitals usually pay for the standard of care ticket items, but for chronic patients this is quite minimal as these patients are considered to already have gone 'through the system' (i.e. they are no longer in the hospital etc.). I have come to realize that the world's economical and business system really is based almost entirely on monetary currency, and unfortunately seems to work most efficiently on that.

    For the clinical trial in Russia, only russians are eligible at this point as the medical system there covers quite extensively some of the standard hospital costs for these patients and they need to come in for check-ups every few weeks to once per month, so they need to live in the Moscow area. This has also allowed us to expand this into a 30 patient clinical trial, which I believe is one of the largest real clinical trials conducted in SCI so far.

    The Regeneration Matrix is like a biomatrix scaffold technology that supports new CNS tissue growth, especially neurite outgrowth and connectivity. It degrades (disappears) in 6-8 weeks as new tissue growth takes its place. The autologous neural stem cells that are also injected are the best geared for building this new CNS tissue as they are the patient's own, and neural stem cells are the cells in the body that differentiate into neurons, astrocytes and oligodendrocytes.
    So high-tech, but very natural and biocompatible. Let's see how this new approach works out when the interim clinical results are published this summer.

  3. #53
    Welcome and good luck Dr. Ahlfors!

  4. #54
    dear Professor Ahlfors thank you for the responce on RMX IS ON CLINICAL TRIAL IN RUSSIA
    I also wanted to know which European countries will be your new sites of study on spinal cord and if non-resident of the country will can participate? because I am really motivated to participate in your clinical trials
    Last edited by fti; 01-28-2015 at 12:03 PM.
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  5. #55
    Dr.Ahlfors,

    I just made donation for Novagenesis Foundation.
    I have 2 questions -

    How this Nonprofit concept is working for your research or would you be able to get enough funds to move fast enough?

    What do you expect will be the most promising therapies & way of moving forward and get cure ready - not only for few
    chosen ones but for the most injured Chronical SCI patients? Can you provide approximate time frame?

    Thank you!

    p.s. I am editing my post as I was not specific in my second question above to Dr. Ahlfors -
    "the most promising therapy" relate to treatments from the New World Lab for SCI.
    I can see that Human Trial with autologous Neural Stem cells start in Russia but
    there are Cell Regeneration Peptides (NWL-53) and Regeneration Matrix and my question is
    What would be the best approach and application to case of SCI if and when all above therapies
    tested, confirmed and approved
    ?
    Or maybe - as all cases of SCI are custom and different approach and therapy will be custom tailored to the patient?

    One more thing - this topic suddenly became vacant that could be
    explained with moving to private discussion board - which I understand as 2 great figures
    Dr. Wise and Dr. Ahlfors can be more productive there - can you please update us with
    hopefully great news about collaboration and faster therapy testing & implementation.
    Last edited by comad; 01-30-2015 at 12:14 AM.
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  6. #56
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    Good Comad. To bring out the therapy on fast tracks if proves successful is the need of time for we chronics.

  7. #57
    I cannot disclose yet at this point which countries as we are still in discussions. The discussions also include looking for ways to have non-residents participate, although this tends to be a tricky topic as the local healthcare systems cover some of the costs of the trials and obviously tax payers don't want to pay these general costs for outsiders. I am also looking at other avenues, but these come with their own problems. I think the best is for us to work on getting solid clinical data as efficiently as possible, and then work with regulators in various countries to try to get Early Access / Compassionate Use approval so that the healthcare system starts to pay for these treatments if they are shown to give clear improvements in patients and are safe.

  8. #58
    Comad,
    Thank you for your donation.
    The non-profit concept of Novagenesis is partially an idea to get donations to act as an alternative to investments, and help to get the product to market faster. Every time I need to raise an investment round, it takes a lot of time and the investors expect a certain return for their risk which inevitably will translate to higher costs for the final product down the road (for example, the average Biotech breakthrough takes 20 years to get to market and has a less than 1% chance of success -- not exactly a very attractive investment offer nor something that you want to offer at the bank for your savings). So Novagenesis is a chance for the public (if they come together in large numbers) to make a difference in the speed and cost of the product development cycle. None of the money raised will be used to enrich anybody nor to pay any management salaries or administrative fees or other cuts, so essentially 100% of the donated money goes towards real & unique research (and larger donations can also pick towards which medical field the donated money will be applied towards). This 100% is way more than what other donation avenues can achieve, as a % (generally 20-60%) first goes into management and administration fees one way or the other, and then the remaining % sometimes ends up partially paying some university overhead costs, etc., and then quite often the remainder of the money ends up being spent on research that's just more of the same. The reason why Novagenesis can apply 100% directly into research is because the rest of all the costs are covered by investments, and the donations are organized to act as booster rockets to get inventions faster to market.

    The patients who have so far received our products in the russian trial have been of the most injured chronic SCI patient variety. I basically started with the worst-case scenarios as I quite often do in my research, as it allows me to determine the basic effect that the product has (if a product has no effect in the worst-case scenarios, then it will not be good enough in my book) and also potentially how to improve it if needed. We have developed several products for SCI, and we are now testing 2 of them in this russian trial (autologous neural stem cells and the Regeneration Matrix). I believe these will be effective for chronic SCI, and since they are platform technologies they have the advantage that they can be boosted further. There is also a third product which is in development that is an autologous spinal cord transplant that could also become important. The cell regeneration peptides will most likely become very important in acute spinal cord injury, but might also have important applications in sub-chronic and chronic SCI, and most definitely in neurodegenerative diseases. Ultimately there will be some custom-tailoring for each patient, but most will be standard based on your time of injury, extent and size of injury.
    I should probably note that I don't consider my greatest strength to be in SCI, but in regeneration, so I approach this field from a slightly different angle than most SCI scientists.

    We have plans for rapid acceleration of everything, but that requires fuel (money). We have the advantage that the autologous neural stem cells are autologous (meaning they are the patient's own) and the Regeneration Matrix is a biomaterial (a Device), which allows for some attractive regulatory options in much of the world once we have solid clinical safety and efficacy data.
    (The price by the way is a lot more than the $1,000 on your website (just the GMP raw materials themselves cost a lot more than that), so this should be corrected. The final price has not yet been decided but will be high in the beginning to cover past investment costs (as explained above) and more importantly to allow investment into larger robotics production equipment and scale-up, as well as future research).
    Last edited by Jan-Eric Ahlfors; 01-30-2015 at 03:08 AM.

  9. #59
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    Really encouraging and great to know about your speed up progress dear Dr. Ahlfors.

  10. #60
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    Dr Ahlfors,

    For your Regeneration Matrix approach, will you be removing the so called "scare" prior to implementation of the matrix?

    Thank you for all your time and effort in SCI research!

    And thank you for spending time with us on CareCure, it's very much appreciated!

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