20 patients, interim results. It all sounds familiar. I can’t see why they couldn’t suffer the same faith as intercytex?
Mr. Hall contends a “moderately successful” clinical trial would result in a 10% increase in hair growth in six to 12 months, which would be equivalent to Rogaine, the first topical FDA-approved product to re-grow hair in both men and women. A “very successful” trial, he figures would result in a 10% to 15% increase in hair growth in six to 12 months, which is equivalent to Propecia, the only FDA-approved, once-a-day pill to help reduce dihydrotestosterone, a key cause of hair loss. An “extremely successful” trial would be a 20%-plus increase in hair growth in six to 12 months, he adds.
http://biotuesdays.com/2011/10/18/replicel’s-cell-based-solution-to-hair-loss/?src=FB_replicel
Hummm, I am surprised that they are aiming so low. I think any cell therapy, if successful, should be significantly more efficient than Finasteride or Minoxidil.
Another bit from the article is also dissapointing:
Mr. Hall says an important advantage of the company’s cell replication technology is that by rejuvenating damaged hair follicles, it would enable early intervention in pattern baldness prior to the development of extensive hair loss.
<<<
this hints to a preventive treatment, not to a “cure” for already bald people.
Well, on the positive side, I am tired of cheerful scientists promising the moon and not delivering anything at all. Lets hope now it is the opposite.
» Mr. Hall contends a “moderately successful” clinical trial would result in
» a 10% increase in hair growth in six to 12 months, which would be
» equivalent to Rogaine, the first topical FDA-approved product to re-grow
» hair in both men and women. A “very successful” trial, he figures would
» result in a 10% to 15% increase in hair growth in six to 12 months, which
» is equivalent to Propecia, the only FDA-approved, once-a-day pill to help
» reduce dihydrotestosterone, a key cause of hair loss. An “extremely
» successful” trial would be a 20%-plus increase in hair growth in six to 12
» months, he adds.
»
»
» http://biotuesdays.com/2011/10/18/replicel’s-cell-based-solution-to-hair-loss/?src=FB_replicel
- “In our animal studies, we’ve been successful 100% of the time in generating new hair growth and creating increased density"
Very good news - it means their cell replication technology is highly reproducible.
- “Mr. Hall contends the cost of developing this technology will be far less than an average drug, biologic or even a stem cell therapy product”
This bodes well for an affordable commercial product
- " Mr. Hall further notes, “100% of the time, they increased hair growth and density by 50%, which is effectively a home run.”
This is amazing, even if only in an animal, they’re able to do it every single time. And if they can get in the vicinity of 50% increase with humans (and there is nothing other than pessimism to say they can’t) then this is the solution we’ve been looking for. I think these are numbers to get excited about. And i believe that common sense would dictate that Replicel, with their targets for success at 10-20% range, are setting investor expectations low in order to mitigate an over reaction should the results end up in that range. From a buisness perspective, you don’t want to underdeliver…never promise more than you deliver. The market would punish that severely and these guys know it. So they set a target they feel they’re going to reach fairly comfortably. It’s merely speculation, but, i would think that they are anticipating trouncing those targets.
This was a very positive article. Can’t wait to hear about thier phase I results in early 2012…only a few months away!
Yes, I agree with this observation.
I feel that David Hall is downplaying everything on purpose.
If they have enough funding with these low expectations, that is already a very good signal.
It makes no sense that, after 10 years of research, they launch clinical trials targeting just a 15% hair increase.
Something is fishy here (in the good sense) 
» get excited about. And i believe that common sense would dictate that
» Replicel, with their targets for success at 10-20% range, are setting
» investor expectations low in order to mitigate an over reaction should the
» results end up in that range. From a buisness perspective, you don’t want
» to underdeliver…never promise more than you deliver. The market would
» punish that severely and these guys know it. So they set a target they feel
» they’re going to reach fairly comfortably. It’s merely speculation, but, i
» would think that they are anticipating trouncing those targets.
»
» This was a very positive article. Can’t wait to hear about thier phase I
» results in early 2012…only a few months away!
I wonder which protocoll they use
» Yes, I agree with this observation.
» I feel that David Hall is downplaying everything on purpose.
» If they have enough funding with these low expectations, that is already a
» very good signal.
»
» It makes no sense that, after 10 years of research, they launch clinical
» trials targeting just a 15% hair increase.
»
» Something is fishy here (in the good sense)
I have suspected for a long time, based on reports like this and Hall’s general tone elsewhere, that they have already tested this on humans. Not “test” in the formal, Stage 2 or 3 sense, but there’s nothing to prevent any insider volunteer from getting informal injections on their own free will. There may have been some bald researcher within Replicel who’s already done this and gotten good results. Certainly they have the most interesting approach of anyone on the scene today and the research infrastructure they’ve put behind this leads me to believe Hall knows at least something more than what he is telling us.
I don’t think the comment about prevention necessarily suggests any problem reversing the condition. Rejuvenation is rejuvenation.
I have never followed the Tricho/Replicel operation too heavily but it always smelled pretty good to me.
If it works, do we have any info to estimate a timeline to reach the commercial market? I’d certainly take a long plane flight to Asia for something like this.
» I don’t think the comment about prevention necessarily suggests any problem
» reversing the condition. Rejuvenation is rejuvenation.
»
» I have never followed the Tricho/Replicel operation too heavily but it
» always smelled pretty good to me.
»
»
» If it works, do we have any info to estimate a timeline to reach the
» commercial market? I’d certainly take a long plane flight to Asia for
» something like this.
Cal, I think that there is potential for this to come out early. I say that because thier technique is autologous…they’re using cells from the patient’s own body. Other than being multiplied, the cells are not changed or manipulated from their original state. Theoretically, it should be very safe. Once they have the safety data from these first trials (and they’ll have a sense of efficacy) i honestly think they could apply in eruope/asia markets to get this commercialized - provided it’s at all efficacious. Autologous procedures are already commonly used and accepted by the medical community as safe. It’s done with in-vitro reproduction procedures daily - this is very similar.
Interestingly, there is lawsuit going on right now between a small biotech and the US FDA. The biotech has a technology which is based on a autologous cell procedure and the FDA is giving them a hard time and requiring them to go through the gauntlet of trials. The company claims the FDA is overstepping their bounds, that autologous procedures are perfectly safe and the FDA has no business trying to overregulate them. If they win their case, that could speed things along in the US for Replicel.
I would love to see win this race. I think they’re up to something good.
» I don’t think the comment about prevention necessarily suggests any problem
» reversing the condition. Rejuvenation is rejuvenation.
»
» I have never followed the Tricho/Replicel operation too heavily but it
» always smelled pretty good to me.
»
»
» If it works, do we have any info to estimate a timeline to reach the
» commercial market? I’d certainly take a long plane flight to Asia for
» something like this.
Interestingly, there’s not a bald one in the bunch other than Peter Lewis who’s been late to the party. Wasn’t one of their Doctors that originated in the company bald at one time?
Replicel won’t be on the market until 2017 or even 2018.
» » I don’t think the comment about prevention necessarily suggests any
» problem
» » reversing the condition. Rejuvenation is rejuvenation.
» »
» » I have never followed the Tricho/Replicel operation too heavily but it
» » always smelled pretty good to me.
» »
» »
» » If it works, do we have any info to estimate a timeline to reach the
» » commercial market? I’d certainly take a long plane flight to Asia for
» » something like this.
»
» Interestingly, there’s not a bald one in the bunch other than Peter Lewis
» who’s been late to the party. Wasn’t one of their Doctors that originated
» in the company bald at one time?
The CEO has a great head of hair
David Hall probably put down on his resume that he was Norwood 1.
That’s why he got the CEO position @ Replicel.
» I have suspected for a long time, based on reports like this and Hall’s
» general tone elsewhere, that they have already tested this on humans. Not
» “test” in the formal, Stage 2 or 3 sense, but there’s nothing to prevent
» any insider volunteer from getting informal injections on their own free
» will. There may have been some bald researcher within Replicel who’s
» already done this and gotten good results. Certainly they have the most
» interesting approach of anyone on the scene today and the research
» infrastructure they’ve put behind this leads me to believe Hall knows at
» least something more than what he is telling us.
A lil somethin for you butt ugly bald MFers to consider :
-
Dr. Rolf Hoffman mentioned in some article that within 2 years of being injected, results are equivalent to a transplant. Now how the hell would he know this unless he actually tried it.
-
Dr. Rolf is in contact with Dr. Batra in India. Cell therapy (and lots of other thrapies) in India are like a sunshine industry. Nothing is regulated as such. So put 2 and 2 together and my guess is Dr. Hoffman might have conducted initial (secret) trials in India with Batra to see if it works and to what extent.
-
The above also explains the time lapse between the initial publication of the paper in 2002 and the start of Phase I which got rolling only in 2010. Of course the time lapse might also be explained by the fact that they were waiting for patent approval in the major western markets. But I’m sure they might have filled that time productively.
-
David Hall slip of the tongue during the interview on the bald truth when he said “we know that in humans…” and he quickly corrected it to “we know that in mice…”
-
All in all, I’m getting good vibes off this company. Their team is detailed oriented, they move methodically and if their sh&t works, it will not only be a cure but a vaccination against future generations having to suffer through this sh&t.
I’ve got a strange “good feeling” about this. Maybe that’s just because I want to hope though. One thing I like is that they are not promising a full head of hair, I get the feeling they are expecting around 50% or maybe more if caught in the early stages.
One thing I really like is that in interviews they have said they will go to market if they can regrow more than 20% because that would make them the new industry standard. So even if it doesn’t work as good as well all hope but it does manage to give you 20% of your hair back… that’s a life-changing win for a lot of us!!!
I currently have 50% of my hair and since starting Propecia a few years ago I haven’t regrown any, but I haven’t lost any. If I can hold my 50% with propecia and get 20% more with this!!! I’m now at around 70%… then I’m a few hair transplants away from being pretty damn close to 100%.
» I’ve got a strange “good feeling” about this. Maybe that’s just because I
» want to hope though. One thing I like is that they are not promising a
» full head of hair, I get the feeling they are expecting around 50% or maybe
» more if caught in the early stages.
»
» One thing I really like is that in interviews they have said they will go
» to market if they can regrow more than 20% because that would make them the
» new industry standard. So even if it doesn’t work as good as well all hope
» but it does manage to give you 20% of your hair back… that’s a
» life-changing win for a lot of us!!!
»
» I currently have 50% of my hair and since starting Propecia a few years ago
» I haven’t regrown any, but I haven’t lost any. If I can hold my 50% with
» propecia and get 20% more with this!!! I’m now at around 70%… then I’m a
» few hair transplants away from being pretty damn close to 100%
This guy seems to be very confident. If it can produce 20% on one pass then 20% on another pass and 20% on third pass, you will have all your hair again. If it produces 20% and no safety issues, it will be available very soon. The reason many of these products take so long to integrate into the market is because they are not efficient. Does not matter how safe if you don’t see results.
On the downside though, the study done by Aderans in mice and human tissue show the stark difference.
The same number of cells injected into mice tissue yielded a fantastic number of follicles. But the same number of cells injected into human tissue yielded only a FEW hair follicles.
Replicel has so far (officially) only conducted these trials in mice. We will only know the results for humans in March 2012 or thereabouts.
Needless to say, while we should expect hair growth of some kind, we should not expect the mice-like results they have had where hair just grows like gang busters.
But if they’ve cracked the above puzzle of getting follicle yields in human tissue at the level they get in mice, we are on our way to hair heaven.
On the other hand, even if the follicular yield is low, it’s also worth trying to find out if results are compoundable. So, instead of one injection, a series of injections over a few years.
» I’ve got a strange “good feeling” about this. Maybe that’s just because I
» want to hope though. One thing I like is that they are not promising a
» full head of hair, I get the feeling they are expecting around 50% or maybe
» more if caught in the early stages.
»
» One thing I really like is that in interviews they have said they will go
» to market if they can regrow more than 20% because that would make them the
» new industry standard. So even if it doesn’t work as good as well all hope
» but it does manage to give you 20% of your hair back… that’s a
» life-changing win for a lot of us!!!
»
» I currently have 50% of my hair and since starting Propecia a few years ago
» I haven’t regrown any, but I haven’t lost any. If I can hold my 50% with
» propecia and get 20% more with this!!! I’m now at around 70%… then I’m a
» few hair transplants away from being pretty damn close to 100%.
Hey suicidal, relax. You’re instincts may be very well right. Did you know that stress makes your hair fall out too!