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The Question Nobody is Asking About Histogen\'s HSC


#1

In the recent interview with Gail Naughton, CEO of Histogen, at the international hair conference, the interviewer asked her a whole range of questions. She said some very promising things about Histogen’s HSC and possible international commercialization opportunities in Japan, Mexico, and other places in the next few years.

She also talked about the new round of trials, which will be to test “dosing” – how much product to use and how much HSC produces what degree of results.

She said that they are looking at a protocol of 2 separate treatments (of multiple scalp injections), spaced several months apart.

My question is, WHY ONLY TWO TREATMENTS?

Is that two treatments per year? Or two per life?

If the stuff really grows hair, then why not more and more treatments until you have a full head of hair?

I already think I know the answer to this question, and it is a bit disturbing.

Think about it – why will HSC be the only drug treatment on the market for hair loss where the number of applications is limited to two?

Apparently NOBODY, including the hair conference interviewer and Dr. Naughton herself, thinks this question is important, because no one has addressed it publicly.

Any ideas???


#2

Wishful thinking but maybe the results she has seen so far are so encouraging that she really doesn’t see the need for more than 2.


#3

[quote][postedby]Originally Posted by roger_that[/postedby]
In the recent interview with Gail Naughton, CEO of Histogen, at the international hair conference, the interviewer asked her a whole range of questions. She said some very promising things about Histogen’s HSC and possible international commercialization opportunities in Japan, Mexico, and other places in the next few years.

She also talked about the new round of trials, which will be to test “dosing” – how much product to use and how much HSC produces what degree of results.

She said that they are looking at a protocol of 2 separate treatments (of multiple scalp injections), spaced several months apart.

My question is, WHY ONLY TWO TREATMENTS?

Is that two treatments per year? Or two per life?

If the stuff really grows hair, then why not more and more treatments until you have a full head of hair?

I already think I know the answer to this question, and it is a bit disturbing.

Think about it – why will HSC be the only drug treatment on the market for hair loss where the number of applications is limited to two?

Apparently NOBODY, including the hair conference interviewer and Dr. Naughton herself, thinks this question is important, because no one has addressed it publicly.

Any ideas???[/quote]

Perhaps you’d like to wait another year or two, for them to run a trial using a third injection, before this stuff comes to market?


#4

Normal trials don’t work like this. It’s more than a single injection per session (more like 50 across the scalp), but why did they decide on only 2 sessions?

I mean, what company in the hair loss field develops a treatment and then asks the FDA to approve a maximum of only two treatment sessions?

The way I see it, if they only run safety and efficacy trials for 2 sessions, then that’s all they will get. That’s all the FDA allow patients to get.

Anyone see it otherwise?

Dr. Naughton needs to be asked exactly this question.


#5

They do the absolute minimum that is necessary to obtain government approval, it is not in their best interest to do more because it will only increase the possibility of side effects and backfire.


#6

[quote][postedby]Originally Posted by roger_that[/postedby]
Normal trials don’t work like this. It’s more than a single injection per session (more like 50 across the scalp), but why did they decide on only 2 sessions?

I mean, what company in the hair loss field develops a treatment and then asks the FDA to approve a maximum of only two treatment sessions?

The way I see it, if they only run safety and efficacy trials for 2 sessions, then that’s all they will get. That’s all the FDA allow patients to get.

Anyone see it otherwise?

Dr. Naughton needs to be asked exactly this question.[/quote]

Why do we need Dr. Naughton to be pressed with this question? Are we trying to throw roadblocks in front of her or do we want our hair back? Aren’t there enough impediments to a cure without we ourselves putting roadblocks in front of potential cures? I say just let her proceed.

Look at the times already that potential cures got abandoned for no good reason. There are at least 2 times that I know of:

  1. RU58841

  2. PS1

We have all been robbed of major portions of our youths and futures. We all could have had so much better lives (to this point) if RU58841 and PS1 had been brought to market. But the drug companies made stupid decisions in both cases so we are dealing with baldness longer than we should have had to. Longer by numerous years. Why do we even want to think about throwing roadblocks in front of drug companies trying to bring hair loss cures to market? Two drug companies have already stopped progress on two medicines that would have solved our problems a decade or more ago.

I’m not interested in trying to stop cures for hair loss from coming to market. The drug companies are doing that all by themselves without any help from us. I think we should encourage Histogen.


#7

[quote][postedby]Originally Posted by roger_that[/postedby]
Normal trials don’t work like this. It’s more than a single injection per session (more like 50 across the scalp), but why did they decide on only 2 sessions?

I mean, what company in the hair loss field develops a treatment and then asks the FDA to approve a maximum of only two treatment sessions?

The way I see it, if they only run safety and efficacy trials for 2 sessions, then that’s all they will get. That’s all the FDA allow patients to get.

Anyone see it otherwise?

Dr. Naughton needs to be asked exactly this question.[/quote]

If she demonstrates that 2 sessions are better than one session Doctors will do AT LEAST 2 sessions. Women may only need two sessions. Many men may be satisfied with 2 sessions. Let’s hope they bring it to market. It’s each individual’s own private business how they do the treatment. Just worry about your own two sessions and let everyone else do as they see fit. This is a personal decision. It’s not right to try to interfere with another person’s medical treatment decisions.


#8

OK, don’t overreact, jarjar, actually I have great respect for Dr. Naughton who is an excellent CEO from everything I can see, and I think HSC is promising and will probably grow hair – better than Rogaine or Propecia, at least.

The reason I’m posing this question is this issue will have to be answered openly sooner or later, so the sooner we understand what’s going on here, the better.

My reading of all this is that because Histogen is packaging their application as a “2 session protocol”, the implication will be that 2 sessions will actually be all a doctor is permitted to offer to one patient – and of course, by extension, all one patient is allowed to have, before assuming risks of side-effects from overuse or chronic use which may make it impermissible to get more than 2 treatments from any doctor or doctors. Personally I believe there may be some kind of tracking system put into place to safeguard against patients getting more than 2 treatments, mainly to reduce any liability for Histogen and especially for doctors.

I think what you said is true, some doctors will offer more than 2 treatments, and I’m also convinced that MANY patients will “doctor shop” to get treatments from multiple doctors. And not only will they want to do this, many, many patients will succeed in doing this, and get a lot more than 2 treatments, because whatever tracking system or safeguards they put into place will be easy to circumvent.

Therefore it might eventually become something where the FDA “turns a blind eye” and pretends not to notice.

Now, I fully realize I’m sounding like the party pooper here with all this negativity.

But I think we have to get this question out in the open and discussed above board early, because we will be facing this issue later, whether we like it or not.

In any event, if all this sounds very weird and improbable to you, well, that’s great but I can’t do anything about that. It may sound completely improbable, but there’s a “first” for everything.

If you think it’s totally unrealistic and stupid for me to predict that there will be some kind of imposed limit on the number of treatments one can get in a certain space of time, just remember that never before has a pharmaceutical hair loss treatment EVER been trialed with limits on the number of successive applications built into the protocol.

It wasn’t done that way for Minoxidil. From the jump, the assumption was ALWAYS that you would just simply use Minoxidil and keep on applying it every day for the rest of your life, if you wanted to keep your hair. And the FDA had no problem with that.

It wasn’t done with Propecia. From the beginning, from the clinical trials, the idea was ALWAYS that you’d take the pills approximately every day for as long as you wanted to, period. And that didn’t bother the FDA or anyone.

So in this regard, HSC is VERY different. If they thought it was OK to administer this stuff every day, every week, every month or whatever, they’d be trialing it in that way.

The fact that they aren’t to me, is kind of a red flag. Not insofar as it won’t work (I think it will work). But it’s just another complication we may have to face if, for instance, it works well in the first 2 treatments, but not nearly enough to be a massive cosmetic improvement, and then people are told that they can’t get more because the safety of more treatments has not been verified.

Call me stupid, naive, an idiot, or whatever you want to call me, but I believe this will be an issue.

All the more reason that research into other hair loss treatments, like Sanford-Burnham, etc., has to be kept going, and we shouldn’t put all our eggs in one basket with Histogen in the short-term or medium-term.

The ultimate cure will be a live-cell based treatment.


#9

A couple things:

  1. I think that there may be some limitations put on the number of Histogen treatments that patients can receive but in the real world it would cost too much to truly enforce it.

  2. If Histogen works then that means that there’s a good chance that SM04554 might also work because both have Wnt as a cornerstone of their therapeutic action.


#10

They want to get an approved working protocol on the market as cheaply and as soon as possible. Doctors will have the ability to prescribe the treatment off-label so that you can get as many treatments as needed.


#11

When is the soonest this stuff is going to come to market and where? There’s talk about Mexico but Mexico isn’t safe. The drugs and drug-gangs are in control of a lot of Mexico and Americans are being kidnapped. Safety is an issue there.


#12

[quote][postedby]Originally Posted by James Bond[/postedby]
They want to get an approved working protocol on the market as cheaply and as soon as possible. Doctors will have the ability to prescribe the treatment off-label so that you can get as many treatments as needed.[/quote]

Depending on what the FDA agrees to with HSC, it may be not be possible to do off-label dosing. HSC isn’t even a drug, it’s a “biological” – the term FDA uses for cells, cell derivatives and biologically-derived extracts.


#13

The violent areas of Mexico you’re talking about are in the north, near the border. Mexico is a huge country and most of it is relatively safe. I’m sure there’ll be clinics in big cities Mexico City, Guadalajara, etc. which are no less safe than an average big city in the US.


#14

[quote][postedby]Originally Posted by roger_that[/postedby]

Depending on what the FDA agrees to with HSC, it may be not be possible to do off-label dosing. HSC isn’t even a drug, it’s a “biological” – the term FDA uses for cells, cell derivatives and biologically-derived extracts.[/quote]

Does Mexico even care what the FDA agrees to with HSC?


#15

The one set of pics that people keep raving about is dubious because the pics are both overhead but the before pic he’s looking
straight ahead and the after pic he’s looking down. In the before pic you can see the facial features because he’s looking straight
ahead. In the after pic it looks like thicker hair is preventing you from seeing the facial features but the real reason you can’t see
his facial features is because he’s looking downward. Sorry. Just being honest.


#16

[quote][postedby]Originally Posted by jarjarbinx[/postedby]
The one set of pics that people keep raving about is dubious because the pics are both overhead but the before pic he’s looking
straight ahead and the after pic he’s looking down. In the before pic you can see the facial features because he’s looking straight
ahead. In the after pic it looks like thicker hair is preventing you from seeing the facial features but the real reason you can’t see
his facial features is because he’s looking downward. Sorry. Just being honest.[/quote]

What treatment are you talking about?


#17

[quote][postedby]Originally Posted by jarjarbinx[/postedby]
The one set of pics that people keep raving about is dubious because the pics are both overhead but the before pic he’s looking
straight ahead and the after pic he’s looking down. In the before pic you can see the facial features because he’s looking straight
ahead. In the after pic it looks like thicker hair is preventing you from seeing the facial features but the real reason you can’t see
his facial features is because he’s looking downward. Sorry. Just being honest.

[postedby]Originally Posted by roger_that[/postedby]

What treatment are you talking about?[/quote]

The subject of this thread is Histogen so I’m talking about Histogen. :wink:

Baseline pic and 24 week pic are overhead views.

If you look at the baseline pic you can’t see the back of the crown and you can’t see down the back of the head at all. On the other hand if you look at the 24 week pic you can see the back of the crown and you can see down the back of the head quite a bit. I think this means that the head is looking downward in the 24 week pic unlike the baseline pic. I think that the difference in the angles is substantial. I think the difference in the angles might be sufficient enough to distort the results significantly.


#18

[quote][postedby]Originally Posted by roger_that[/postedby]
OK, don’t overreact, jarjar, actually I have great respect for Dr. Naughton who is an excellent CEO from everything I can see, and I think HSC is promising and will probably grow hair – better than Rogaine or Propecia, at least.

The reason I’m posing this question is this issue will have to be answered openly sooner or later, so the sooner we understand what’s going on here, the better.

My reading of all this is that because Histogen is packaging their application as a “2 session protocol”, the implication will be that 2 sessions will actually be all a doctor is permitted to offer to one patient – and of course, by extension, all one patient is allowed to have, before assuming risks of side-effects from overuse or chronic use which may make it impermissible to get more than 2 treatments from any doctor or doctors. Personally I believe there may be some kind of tracking system put into place to safeguard against patients getting more than 2 treatments, mainly to reduce any liability for Histogen and especially for doctors.

I think what you said is true, some doctors will offer more than 2 treatments, and I’m also convinced that MANY patients will “doctor shop” to get treatments from multiple doctors. And not only will they want to do this, many, many patients will succeed in doing this, and get a lot more than 2 treatments, because whatever tracking system or safeguards they put into place will be easy to circumvent.

Therefore it might eventually become something where the FDA “turns a blind eye” and pretends not to notice.

Now, I fully realize I’m sounding like the party pooper here with all this negativity.

But I think we have to get this question out in the open and discussed above board early, because we will be facing this issue later, whether we like it or not.

In any event, if all this sounds very weird and improbable to you, well, that’s great but I can’t do anything about that. It may sound completely improbable, but there’s a “first” for everything.

If you think it’s totally unrealistic and stupid for me to predict that there will be some kind of imposed limit on the number of treatments one can get in a certain space of time, just remember that never before has a pharmaceutical hair loss treatment EVER been trialed with limits on the number of successive applications built into the protocol.

It wasn’t done that way for Minoxidil. From the jump, the assumption was ALWAYS that you would just simply use Minoxidil and keep on applying it every day for the rest of your life, if you wanted to keep your hair. And the FDA had no problem with that.

It wasn’t done with Propecia. From the beginning, from the clinical trials, the idea was ALWAYS that you’d take the pills approximately every day for as long as you wanted to, period. And that didn’t bother the FDA or anyone.

So in this regard, HSC is VERY different. If they thought it was OK to administer this stuff every day, every week, every month or whatever, they’d be trialing it in that way.

The fact that they aren’t to me, is kind of a red flag. Not insofar as it won’t work (I think it will work). But it’s just another complication we may have to face if, for instance, it works well in the first 2 treatments, but not nearly enough to be a massive cosmetic improvement, and then people are told that they can’t get more because the safety of more treatments has not been verified.

Call me stupid, naive, an idiot, or whatever you want to call me, but I believe this will be an issue.

All the more reason that research into other hair loss treatments, like Sanford-Burnham, etc., has to be kept going, and we shouldn’t put all our eggs in one basket with Histogen in the short-term or medium-term.

The ultimate cure will be a live-cell based treatment.[/quote]

Roger_that, how would you compare HSC with Botox injection for wrinkles as far as dosing is concerned?


#19

I don’t understand why this is an issue whether treatment is limited to 2 or 5 or however frequent it is. Do you think the trial should be for 1 treatment only or greater than 2?


#20

[quote][postedby]Originally Posted by ipod[/postedby]
I don’t understand why this is an issue whether treatment is limited to 2 or 5 or however frequent it is. Do you think the trial should be for 1 treatment only or greater than 2?[/quote]

Greater than 2, of course. If HSC gives promising results with 2 sessions, wouldn’t you like to see how much improvement 3, 5, 10, or 20 sessions could make?