RepliCel - Spencer Kobren's Follow Up Interview With CEO David Hall

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  • NotBelievingIt
    Senior Member
    • Oct 2011
    • 595

    Originally posted by StressedToTheBald
    Aren't You at least a bit worried about the safety ?
    RepliCel has repeatedly stated that they are using an autologous technique.

    Originally posted by http://www.thefreedictionary.com/autologous
    au·tol·o·gous (ô-tl-gs)
    adj.
    Derived or transferred from the same individual's body: autologous blood donation; an autologous bone marrow transplant.
    What this means is, there is no foreign chemical introduced into the body.

    The cells are multiplied in a neutral solution that is basically a pH of 7, the body has no reaction to it - or rather, shouldn't

    In other words, all they are doing is taking your cells, multiplying them and putting them back, albeit in a different location.

    The thing with their Phase I trial is that it is both a safety and efficacy. It can't not be. So while they will report no concerns, they will also know safety and efficacy, so the second set of trials is basically just more of the same - just on a larger patient base.

    Thats the beauty of autologous techniques. Its already known to be perfectly safe*, but the FDA stands for Fraking Dumb Ass and won't acknowledge autologous separately then a chemical based drug trial.

    Originally posted by Maradona
    I'm concerned that it might not be effective for slick bald men...can they really reactivate those follicles? or will it only work for minituarized hairs...which Dr. Rolf hoffman suggested in an interview i've read somewhere.

    I know they only recruit norwood 3 n 4 in the trial so thats not good news. I don't think I will have any hair left when the "SAVING" is here.
    Slick Bald men are likely to see significantly less, or slower, growth in my opinion. It would depend entirely upon just how dormant the folliciles are. Did they really just stop growing, or is their growth phase so shortened that they barely/never breach the surface? The hair needs strength to push through the skin, so if it lacks that strength, the DSC might just provide the backbone needed. If the DSC really does shield the follicile it should in theory return to normal growth cycles. Growth stimulants like Minoxidil or other topicals/orals might need to be taken to speed the process up though, but once the growth has taken hold at acceptable levels, the treatment could be stopped because it would not be needed to maintain the growth.

    Its fun to theorize! But also depressing to imagine it not working like that

    One concern that should be noted with being totally bald is that the growth would potentially be spotty for quite some time and might look terrible. Spotty growth when there already is hair would be tolerable though, IMO.

    Comment

    • StressedToTheBald
      Inactive
      • Jan 2012
      • 452

      Originally posted by gmonasco
      Phase I trials do not demonstrate a product to be safe; they are performed on small groups to identify any obvious health concerns before moving on to the next phase of testing. Safety issues may still be uncovered in later phases of testing as the sizes of the sample groups increase (as demonstrated by a number of products that have been recalled for safety issues even after finishing clinical trials and reaching the market).
      Exactly what I was thinking of.

      Comment

      • 2020
        Senior Member
        • Jan 2012
        • 1527

        Originally posted by NotBelievingIt
        Thats the beauty of autologous techniques. Its already known to be perfectly safe*, but the FDA stands for Fraking Dumb Ass and won't acknowledge autologous separately then a chemical based drug trial.
        isn't Replicel based in CANADA?

        Comment

        • StressedToTheBald
          Inactive
          • Jan 2012
          • 452

          Originally posted by NotBelievingIt
          RepliCel has repeatedly stated that they are using an autologous technique.

          What this means is, there is no foreign chemical introduced into the body.

          The cells are multiplied in a neutral solution that is basically a pH of 7, the body has no reaction to it - or rather, shouldn't
          Yes, but stem cells for example can also be from one's own body, and cancer is one of the worries with stem cells.. These as far as I know are not stem cells, but still.. one should better be safe than sorry.

          Comment

          • NotBelievingIt
            Senior Member
            • Oct 2011
            • 595

            Originally posted by 2020
            isn't Replicel based in CANADA?
            Yes, but their trials are occuring in the USA so they must go through the FDA. I'm sure the Canadian equivalent is in the loop too.

            Comment

            • Maradona
              Senior Member
              • Nov 2011
              • 830

              Originally posted by NotBelievingIt
              RepliCel has repeatedly stated that they are using an autologous technique.



              What this means is, there is no foreign chemical introduced into the body.

              The cells are multiplied in a neutral solution that is basically a pH of 7, the body has no reaction to it - or rather, shouldn't

              In other words, all they are doing is taking your cells, multiplying them and putting them back, albeit in a different location.

              The thing with their Phase I trial is that it is both a safety and efficacy. It can't not be. So while they will report no concerns, they will also know safety and efficacy, so the second set of trials is basically just more of the same - just on a larger patient base.

              Thats the beauty of autologous techniques. Its already known to be perfectly safe*, but the FDA stands for Fraking Dumb Ass and won't acknowledge autologous separately then a chemical based drug trial.



              Slick Bald men are likely to see significantly less, or slower, growth in my opinion. It would depend entirely upon just how dormant the folliciles are. Did they really just stop growing, or is their growth phase so shortened that they barely/never breach the surface? The hair needs strength to push through the skin, so if it lacks that strength, the DSC might just provide the backbone needed. If the DSC really does shield the follicile it should in theory return to normal growth cycles. Growth stimulants like Minoxidil or other topicals/orals might need to be taken to speed the process up though, but once the growth has taken hold at acceptable levels, the treatment could be stopped because it would not be needed to maintain the growth.

              Its fun to theorize! But also depressing to imagine it not working like that

              One concern that should be noted with being totally bald is that the growth would potentially be spotty for quite some time and might look terrible. Spotty growth when there already is hair would be tolerable though, IMO.
              well since there's an interview coming up in the baldtruth show before the results are published, these are the questions we should ask to the scientists. If they think, it can grow hair on slick bald spots or not.

              Comment

              • NotBelievingIt
                Senior Member
                • Oct 2011
                • 595

                Originally posted by StressedToTheBald
                Yes, but stem cells for example can also be from one's own body, and cancer is one of the worries with stem cells.. These as far as I know are not stem cells, but still.. one should better be safe than sorry.
                I agree.

                The key difference though is a stem cell is undifferentiated. It has a far greater chance of differentiating and mutating along the way to introduce something that shouldn't be there, which is basically what cancer boils down to.

                While not impossible with already differentiated cell multiplication, my highly accredited Internet Genetics Degree from Google University says it is far less likely.

                Comment

                • gmonasco
                  Inactive
                  • Apr 2010
                  • 883

                  Originally posted by NotBelievingIt
                  Thats the beauty of autologous techniques. Its already known to be perfectly safe*, but the FDA stands for Fraking Dumb Ass and won't acknowledge autologous separately then a chemical based drug trial.
                  See the following comments earlier in this thread:



                  Comment

                  • greatjob!
                    Senior Member
                    • Aug 2011
                    • 910

                    Originally posted by NotBelievingIt
                    RepliCel has repeatedly stated that they are using an autologous technique.

                    In other words, all they are doing is taking your cells, multiplying them and putting them back, albeit in a different location.

                    Thats the beauty of autologous techniques. Its already known to be perfectly safe*, but the FDA stands for Fraking Dumb Ass and won't acknowledge autologous separately then a chemical based drug trial.
                    While I agree that there is more than likely not going to be any significant safety issues with Replicel’s treatment. The information you have posted is inaccurate. Just because you’re using an autologous treatment doesn't mean there are no risks. Cancer cells are your OWN cells that have begun to multiply uncontrolled or that are unable to undergo auto phagocytosis. The most common type of cancer is skin cancer because your skin cells are the cells that regenerate the most often via mitosis. During mitosis if there is a mutation of the DNA->RNA->Protein and the cell does not catch this mistake and go through auto phagocytosis, programmed cell death, there is a possibility that the cell may become cancerous. Most terminal cancers don't cause death by simply existing, they cause death when they migrate to other parts of the body and cause disorder.

                    Taking cells out of the body, forcing them to multiply, and re-injecting the multiplied cells will always pose a risk of becoming cancerous until we COMPLETLEY understand all mechanisms of the cell, and right now we still do not.

                    Comment

                    • NotBelievingIt
                      Senior Member
                      • Oct 2011
                      • 595

                      Interesting reads.

                      Of the two, only the second one with:
                      But as far as Replicel is concerned, basically there is going to be a hyper-expression of genes and growth factors in vivo such as hasn't been seen in the scalp since you were a developing embryo. Who knows what that might do? It SHOULD be okay but there might be unknown processes going on that nobody yet knows about. Better safe than sorry.
                      ...
                      So what happens if there are mutations along the line? What if a mutation happens early on and carries down through billions of daughter cells? What if those cells now hyper-express a protein that causes cancer?
                      has the most bearing on RepliCel in my opinion.

                      I don't like the use of the term stem cell and embryo together. It implies they are undifferentiated stem cells and they are not.

                      Comment

                      • gmonasco
                        Inactive
                        • Apr 2010
                        • 883

                        Originally posted by Maradona
                        I wouldn't wait a second if it comes out or if they take me for the trial (i'd move to georgia, canada).
                        Why? What would you expect to gain from being a participant in a Phase II clinical trial?

                        Comment

                        • eqvist
                          Member
                          • Aug 2011
                          • 96

                          A thing a wunder about. Do we really going to have the answer if it safe in just one year ?

                          Comment

                          • 2020
                            Senior Member
                            • Jan 2012
                            • 1527

                            Don't care about safety.... 10% chance of death - don't care just grow me some hair!!

                            Comment

                            • Maradona
                              Senior Member
                              • Nov 2011
                              • 830

                              Originally posted by gmonasco
                              Why? What would you expect to gain from being a participant in a Phase II clinical trial?
                              a rocking full head of hair?



                              Originally posted by 2020
                              Don't care about safety.... 10% chance of death - don't care just grow me some hair!!
                              same.

                              Comment

                              • 2020
                                Senior Member
                                • Jan 2012
                                • 1527

                                Yeah if they do enroll you into their study, then you would know in advance if their treatment worked or not.
                                If it did work then it would be safe to put all of your money into their stock and make that money 300% back! That's almost insider trading

                                Comment

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