Replicel

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  • gmonasco
    Inactive
    • Apr 2010
    • 883

    Originally posted by hollywoodkid
    Has Replicel done any testing at all, even on mice, that shows that their injectable works in at least some organism? Or is it all just a 'theory' that this will work?

    Comment

    • Follicle Death Row
      Senior Member
      • May 2011
      • 1066

      I've a few questions. They may not be able to answer them this early in the process but here goes anyway:

      1. On an area of bald scalp will an injection of dermal sheath cup cells induce growth of single hairs or multi hair follicles? This is important for producing real volume and the appearance of density.

      2. Do the injected cells bring back the old follicles or create entirely new ones? As in if a 3 haired follicle was there before the balding process will that come back or would only a single hair follicle grow?

      3. Compared to native non miniturised hair, does the new hair have similiar shaft diameter thickness? Is the shaft thickness similiar to the hair in the donor area?

      4. Is the growth direction a non issue?

      5. Is the new hair permanent or are repeated procedures or touch ups required periodically? I only ask this as a biopsy is required. We would all like to avoid multiple punches so is it possible that some DSC cells can be kept in a 'hair bank' so to speak in order to multiply them again and inject them when the patient requires some time down the line?

      6. It's probably too early to ask this one but what sort of density in terms of FU/cm2 can this procedure restore? Are the effects of multiple procedures cumulative? i.e. Would a second pass give the patient more density?

      7. Do Replicel forsee the hairline and temple points being problematic? Is there a case here for the synergistic use of a minor FUE session to assert better control over the hairline and ensure the patient the aesthetic result they desire?

      8. What timeline are we realistically looking at to get this to market? Is a third phase of clinical trials planned? What's the estimated cost?

      9. How come Aderans are going the FDA route with a similiar procedure whereas Replicel are seemingly not?


      Hopefully I've laid out some the queries that you guys have too.

      Comment

      • NotDyingBald
        Member
        • Jun 2011
        • 48

        Well, my first post in this forum. Been watchin´it for a while.

        About a phase 3 planned, don´t know but, here´s something i haven´t see anyone noticed:



        It´s been on the website for 2 weeks.

        "Our clinical team has initiated discussions with regulators in Europe and Canada in anticipation of positive data from our ongoing phase I/IIa clinical trial."

        Let´s remember that end of July was the timeline for the injections of all patients in the study. Q1 2012 data, it´s because by then, 6 months passed since the last patient injected. Who knows if, 6 months after the first patient injection(they started Dec`10) they are already seeing good results that makes them think that it´s worth to start planning bigger trials?

        Already signed in, since i´m from Europe.

        Comment

        • Bronson
          Member
          • Aug 2011
          • 35

          Originally posted by Follicle Death Row
          I've a few questions. They may not be able to answer them this early in the process but here goes anyway:

          1. On an area of bald scalp will an injection of dermal sheath cup cells induce growth of single hairs or multi hair follicles? This is important for producing real volume and the appearance of density.

          2. Do the injected cells bring back the old follicles or create entirely new ones? As in if a 3 haired follicle was there before the balding process will that come back or would only a single hair follicle grow?

          3. Compared to native non miniturised hair, does the new hair have similiar shaft diameter thickness? Is the shaft thickness similiar to the hair in the donor area?

          4. Is the growth direction a non issue?

          5. Is the new hair permanent or are repeated procedures or touch ups required periodically? I only ask this as a biopsy is required. We would all like to avoid multiple punches so is it possible that some DSC cells can be kept in a 'hair bank' so to speak in order to multiply them again and inject them when the patient requires some time down the line?

          6. It's probably too early to ask this one but what sort of density in terms of FU/cm2 can this procedure restore? Are the effects of multiple procedures cumulative? i.e. Would a second pass give the patient more density?

          7. Do Replicel forsee the hairline and temple points being problematic? Is there a case here for the synergistic use of a minor FUE session to assert better control over the hairline and ensure the patient the aesthetic result they desire?

          8. What timeline are we realistically looking at to get this to market? Is a third phase of clinical trials planned? What's the estimated cost?

          9. How come Aderans are going the FDA route with a similiar procedure whereas Replicel are seemingly not?


          Hopefully I've laid out some the queries that you guys have too.
          Good questions all, I recommend Spencer ask these to start with.

          Comment

          • elvispresley
            Senior Member
            • Jun 2011
            • 115

            Originally posted by NotDyingBald
            Well, my first post in this forum. Been watchin´it for a while.

            About a phase 3 planned, don´t know but, here´s something i haven´t see anyone noticed:



            It´s been on the website for 2 weeks.

            "Our clinical team has initiated discussions with regulators in Europe and Canada in anticipation of positive data from our ongoing phase I/IIa clinical trial."

            Let´s remember that end of July was the timeline for the injections of all patients in the study. Q1 2012 data, it´s because by then, 6 months passed since the last patient injected. Who knows if, 6 months after the first patient injection(they started Dec`10) they are already seeing good results that makes them think that it´s worth to start planning bigger trials?

            Already signed in, since i´m from Europe.
            replicel looks very good... (we need to see the result) in Q1 2012...

            anyway im from europe , can i know what i need to be accepted into the next trials? and where they will do them? i tried to find info on the website but i couldn't ... if someone knows let me know thx

            Comment

            • krewel
              Senior Member
              • Aug 2011
              • 188

              What bothers me, well maybe even one of u can answer that:
              How will they make sure, that hairs only grow in a certain area? I mean, in their videos it's being said, their techqique also produces new hair follicles. Unfortunatley, we dont want hair to grow out of our forehead, haha.

              Comment

              • uninformed
                Senior Member
                • Aug 2011
                • 102

                Originally posted by krewel
                What bothers me, well maybe even one of u can answer that:
                How will they make sure, that hairs only grow in a certain area? I mean, in their videos it's being said, their techqique also produces new hair follicles. Unfortunatley, we dont want hair to grow out of our forehead, haha.
                Yeh was wondering about that too... especially near the hairline, how do you control where the hair growth is gonna be located?

                Comment

                • DepressedByHairLoss
                  Senior Member
                  • Feb 2011
                  • 876

                  Originally posted by NotDyingBald
                  Well, my first post in this forum. Been watchin´it for a while.

                  About a phase 3 planned, don´t know but, here´s something i haven´t see anyone noticed:



                  It´s been on the website for 2 weeks.

                  "Our clinical team has initiated discussions with regulators in Europe and Canada in anticipation of positive data from our ongoing phase I/IIa clinical trial."

                  Let´s remember that end of July was the timeline for the injections of all patients in the study. Q1 2012 data, it´s because by then, 6 months passed since the last patient injected. Who knows if, 6 months after the first patient injection(they started Dec`10) they are already seeing good results that makes them think that it´s worth to start planning bigger trials?

                  Already signed in, since i´m from Europe.
                  Man, if this was Histogen, I would've signed in in a second. No biopsies or punching, and nothing but potential benefits.

                  Comment

                  • Kiwi
                    Senior Member
                    • Mar 2011
                    • 1105

                    Originally posted by DepressedByHairLoss
                    Man, if this was Histogen, I would've signed in in a second. No biopsies or punching, and nothing but potential benefits.
                    Just a quick question, would you personally feel safe being part of a Histogen clinical trial? I sometimes wonder about it myself...

                    Comment

                    • Follicle Death Row
                      Senior Member
                      • May 2011
                      • 1066

                      Originally posted by uninformed
                      Yeh was wondering about that too... especially near the hairline, how do you control where the hair growth is gonna be located?
                      I wonder the same. Perhaps FUE can play a role in tackling the hairline. Perhaps the first 1 to 1.5cm could be approached using FUE to ensure the aesthetic result the patient wants. Some people have had extensive FUE and their donors have the moth eaten look. I wonder could this Replicel techniqe be used to recharge their donor so to speak to make it look normal.

                      Comment

                      • Follicle Death Row
                        Senior Member
                        • May 2011
                        • 1066

                        Originally posted by Kiwi
                        Just a quick question, would you personally feel safe being part of a Histogen clinical trial? I sometimes wonder about it myself...
                        I don't know about others but I wouldn't want a part in any of the clinical trials. I'll happily take the finished product when they've perfected it but not until then.

                        Comment

                        • Losing_It
                          Member
                          • Jun 2011
                          • 89

                          Originally posted by DepressedByHairLoss
                          Man, if this was Histogen, I would've signed in in a second. No biopsies or punching, and nothing but potential benefits.
                          At the moment beggars can't be chooses. A 4mm punch biopsy won't be so bad if it means a significant amount of hair will grow back and will have . Also Spencer seems really taken by them, so I hope that counts for something.

                          Comment

                          • krewel
                            Senior Member
                            • Aug 2011
                            • 188

                            And something else I ask myself: Are the cells still multiplying under the scalp? Maybe I'm in a total wrong direction, but isn't there a risk to get cancer?

                            Comment

                            • Follicle Death Row
                              Senior Member
                              • May 2011
                              • 1066

                              Originally posted by krewel
                              And something else I ask myself: Are the cells still multiplying under the scalp? Maybe I'm in a total wrong direction, but isn't there a risk to get cancer?
                              Cells are multiplied in the lab. It's very safe. That won't be a concern. They're just making more dermal sheath cup cells and putting them back into your scalp. In fact they seem to be able to bypass the FDA with this because it's autologous.

                              Comment

                              • krewel
                                Senior Member
                                • Aug 2011
                                • 188

                                Originally posted by Follicle Death Row
                                Cells are multiplied in the lab. It's very safe. That won't be a concern. They're just making more dermal sheath cup cells and putting them back into your scalp. In fact they seem to be able to bypass the FDA with this because it's autologous.
                                FDA = Phase III?

                                Comment

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