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Originally Posted by UK_
You have to also remember that Replicel has not figured out 'dosing range' yet - this phase was primarily for safety, when they explore what dose works best I am sure we will see far better results.
Isn't the Phase I dose an overdose? (Correct me if I'm wrong, somebody!)
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Originally Posted by Kirby_
Isn't the Phase I dose an overdose? (Correct me if I'm wrong, somebody!)
Yes, if they overdosed the mice and got 3% results, wheras if they gave the proper lower dosage and that resulted in +50%, then it is significant. Otherwise, we don't have a good reason for the variance.
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They say their results were positive, if its just 6% growth then in the bigger picture how is that positive?
Do they think it will grow loads of hair with in increased dose?
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Originally Posted by Kirby_
Isn't the Phase I dose an overdose? (Correct me if I'm wrong, somebody!)
I think it is a range of high to low doses. What results did the high doses show?
I'd guess there where 4 or 5 levels in the whole range. Subjects at the high end of the range may show better results. With only 19 subjects, there's not much significance to be drawn on from these results in terms of efficacy.
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Originally Posted by Kirby_
Isn't the Phase I dose an overdose? (Correct me if I'm wrong, somebody!)
Where have Replicel said they overdosed on this trial? How can they overdose when they do not know the optimal dosage yet?
No dosages have been defined, they are only in phase 1 of clinical trials. Are people confusing an overdose with dose ranges?
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Why don't they try injecting human hairs onto immunologically neutralized mice, then transplanting the hairs onto human scalps.
If everyone keeps trying the same thing it'll be decades before they finally realize the human scalp is only good at fostering growth of hair follicles at a young age. Something changes as we get older, and the environment is not good for growth of new follicles. That's why these treatments work like magic on mice, but not humans.
Farm the follicles on mice or pigs, and transplant them
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How did they get funding for phase 2? Quite frankly they don't have results good enough to proceed to phase 2. I don't understand.
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Originally Posted by Follicle Death Row
Horrible results. Almost insignificant statistically. And there was David Hall saying anything above 30% would be a massive success. Time to move on.
I like the lateral thinking of growing follicles on mice and transplanting them. Interesting. I'll take 100 mice please!
Time to move on, indeed.
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As of now the results are:
12.5% increase in Vellus hair
3.2% increase in terminal hair
The fate of those 12.5% vellus will be very important. If they develop into terminal hairs over the next 6 months or so, then they might be on to something. And as IPenegry has noted, there is the possibility that these results could be compoundable. If that's the case, then this would be a good result. But, only if those vellus hairs grow to terminals.
Two things i had a question about before they even started the trial were: at what depth are they making these injections and how far can these cells migrate once injected?
Suppose these cells don't migrate from the site of injection very far, if at all? Suppose that the injection depth used in this protocol is not optimal?
If those two variables were not dialed in correctly for human scalp then it could explain their poor response.
Phase II is going to be an exploratory phase, much the same that Aderans went through. It has the potential to be a long time span. But, i sure as heck hope not.
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