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

  1. #71
    Senior Member Stormycoon's Avatar
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    yeah thnxs GRAMMY.. years ago when i conversed with J.E.A he claimed because the cellular therapies are not considered a drug, and RMx is a ''device'' they most likely could be ''fast-tracked'' to completion.. A 4 year Phase 1/2 trial isnt necessarily that... dang..These recipients must be so stoked though.
    I am not your rolling wheels
    I am the highway
    I am not your carpet ride
    I am the sky
    I am not your blowing wind
    I am the lightning
    I am not your autumn moon
    I am the night, the night..

  2. #72
    Quote Originally Posted by Stormycoon View Post
    yeah thnxs GRAMMY.. years ago when i conversed with J.E.A he claimed because the cellular therapies are not considered a drug, and RMx is a ''device'' they most likely could be ''fast-tracked'' to completion.. A 4 year Phase 1/2 trial isnt necessarily that... dang..These recipients must be so stoked though.
    Well Stormy, the FDA is trying to change the rules on injecting our own stem cells back into ourselves after they've been manipulated in a lab for us. It appears the rules are changing now and those cells will be regulated as though they are a drug.

  3. #73
    Quote Originally Posted by Jan-Eric Ahlfors View Post
    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).
    Thank you Dr. Ahlfors for joining carecure to share info about what you are doing.

    In reference to what is posted on clinicaltrial.gov:
    "Detailed Description:The aim of this study is to evaluate Mesenchymal Stem Cells [MSC]-derived autologous neural stem cells transplantation as a safe and potentially beneficial treatment for patients with traumatic spinal cord."
    https://clinicaltrials.gov/ct2/show/...hronic&rank=20

    Could you provide more info (if possble published) on how you turn MSC into neural stem cells?
    Also what kind of recovery have you observed in animal models? Can you point me to any publications?

    Thank you.

    Paolo
    Last edited by paolocipolla; 02-04-2015 at 07:28 AM.
    In God we trust; all others bring data. - Edwards Deming

  4. #74
    Senior Member Stormycoon's Avatar
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    Quote Originally Posted by GRAMMY View Post
    Well Stormy, the FDA is trying to change the rules on injecting our own stem cells back into ourselves after they've been manipulated in a lab for us. It appears the rules are changing now and those cells will be regulated as though they are a drug.
    Well Prof. Grammy, let me tell you. Typical over-riding dominating fffinng control.
    I am not your rolling wheels
    I am the highway
    I am not your carpet ride
    I am the sky
    I am not your blowing wind
    I am the lightning
    I am not your autumn moon
    I am the night, the night..

  5. #75
    Quote Originally Posted by Stormycoon View Post
    Well Prof. Grammy, let me tell you. Typical over-riding dominating fffinng control.
    Here's the thread posted a few days ago by c473s with links into a blog that explains what has been happening over the past few years.

    http://sci.rutgers.edu/forum/showthr...FDA-and-trials

  6. #76
    Quote Originally Posted by GRAMMY View Post
    Information about New World Lab - Regeneration Matrix

    http://www.nwl.net/

    http://www.onemedplace.com/database/list/cid/13990/

    RMx: a biomaterial (Device) with potent regenerative and wound healing properties that is able to present some drugs and growth factors at higher potency (growth factor presentation). Potent anti-scarring, wound healing, and tissue regeneration properties, including muscle and neuronal tissue regeneration.

    Competitors / Substitutes / AlternativesNWL-053: Merck M867 - pre-clinical phase peptidomimetic drug; suffers from toxicity problems.

    NWL-NSC: NeuralStem Inc., ReNeuron, and StemCell Inc. - all use fetal neural stem cells that suffer from low potency, ethical and immunogenicity problems.

    RMx: closest competitor is platelet-rich plasma (PRP) which has a significantly lower potency and regenerative ability than RMx in side-by-side studies.

    StatusNWL is at the pre-clinical stage. ~$20M has been invested (equity & grants) into developing a dominant IP position. NWL-053 and NWL-NSC could complete Phase I/IIa Clinical Trials within 2 years after financing, after which either an IPO or an out-licensing deal could be consummated. RMx (a Device) could complete Pivotal Clinical Trials and receive Market Approval within 3 years.

    Canadian Research Council:

    http://www.nrc-cnrc.gc.ca/eng/disclo...eport&id=13683
    Was that 20 million mainly from Russia or Canada?

  7. #77
    Anyone have any updates? Is recruitment finished? Any surgery started?

  8. #78
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    This trial is also hope. Let us see how results come by this summer from phase one trial

  9. #79
    Of all the research going on right now, after reading more in depth about the technology involved this is The most promising in my opinion.

  10. #80
    Quote Originally Posted by paolocipolla View Post
    Thank you Dr. Ahlfors for joining carecure to share info about what you are doing.

    In reference to what is posted on clinicaltrial.gov:
    "Detailed Description:The aim of this study is to evaluate Mesenchymal Stem Cells [MSC]-derived autologous neural stem cells transplantation as a safe and potentially beneficial treatment for patients with traumatic spinal cord."
    https://clinicaltrials.gov/ct2/show/...hronic&rank=20

    Could you provide more info (if possble published) on how you turn MSC into neural stem cells?
    Also what kind of recovery have you observed in animal models? Can you point me to any publications?

    Thank you.

    Paolo
    Dr. Ahlfors,

    hope you will find the time to come back on CareCure.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

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