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.
Well, my first post in this forum. Been watchinīit for a while.
About a phase 3 planned, donīt know but, hereīs something i havenīt see anyone noticed:
Itīs 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."
Letīs remember that end of July was the timeline for the injections of all patients in the study. Q1 2012 data, itīs 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 itīs worth to start planning bigger trials?
Already signed in, since iīm from Europe.
Good questions all, I recommend Spencer ask these to start with.
Originally Posted by Follicle Death Row
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?
Originally Posted by krewel
Man, if this was Histogen, I would've signed in in a second. No biopsies or punching, and nothing but potential benefits.
Originally Posted by NotDyingBald
Just a quick question, would you personally feel safe being part of a Histogen clinical trial? I sometimes wonder about it myself...
Originally Posted by DepressedByHairLoss
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.
Originally Posted by uninformed
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