Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering

[mjolnir]

I hope your right. I don't get what phase 3 is for. Phase 1 is primarily for safety and phase 2 is to test efficacy. What do we need phase 3 for ?

If your treatment results in the agonizing death of 1 out of every 100 patients (maybe they have some rare, recessive gene, for instance), then a 50 person phase 1 trial isn't necessarily going to catch that. A 3000 person phase 3 trial, on the other hand, might. There is actually a reason for the way things are done. I agree it's frustrating, but personally I don't plan on rushing off to Asia the instant this is available.

[john2399]

Not all countries require phase 3. This is why they could release in asia sooner if they wanted.

I hope your right. I don't get what phase 3 is for. Phase 1 is primarily for safety and phase 2 is to test efficacy. What do we need phase 3 for ?

[WashedOut]

I want to know that question too does outside countries need phase 3? i hate how these trials r so dam long

Not all countries require phase 3. This is why they could release in asia sooner if they wanted.

[mjolnir]

Regarding the length of trials, do keep in mind that this is still a very new and experimental treatment. Maybe the FDA does make things take a bit longer than is absolutely necessary - I really don't know - but it's not actually a bad idea to be extra sure that Histogen is safe. I certainly don't enjoy having a bald spot, but at the end of the day this is still a purely cosmetic treatment that we're talking about.

[john2399]

Phase 2 will last a full year - january to december.

Yes, phase 3(if even needed for Asia) will start sometime in 2013 and ends in probably 2014.

2014-2015 for asia and 2015-2016 is not unrealistic at this point.

I want to know that question too does outside countries need phase 3? i hate how these trials r so dam long

[2020]

Sorry for repeating...
So basically now we have to wait till December until we hear from them again?
Till then they'll be done with Phase 2 (0.5 years) and Phase 3 will start (1 year), then FDA approval (1-2 years for USA) and release in Asia (approx. 1 year)?
My estimation: 4.5 years for USA and 3.5 years for Asia?
Does it seem legit?

Phase 2 will last a full year - january to december.

Yes, phase 3(if even needed for Asia) will start sometime in 2013 and ends in probably 2014.

2014-2015 for asia and 2015-2016 is not unrealistic at this point.

[Gjm127]

Sorry for repeating...
So basically now we have to wait till December until we hear from them again?
Till then they'll be done with Phase 2 (0.5 years) and Phase 3 will start (1 year), then FDA approval (1-2 years for USA) and release in Asia (approx. 1 year)?
My estimation: 4.5 years for USA and 3.5 years for Asia?
Does it seem legit?

[Tracy C]

The number of injections it might possibly be does not bother me - as long as their treatment works. They could always map your scalp and create a template, similar to the way prosthetic hair is made, to get the injections right.

[2020]

Ouch.
Sounds no worse than the thousands of cuts made during a transplant though.

I truly hope Histogen will figure out a way to lessen the number of injections....

[25 going on 65]

I think hairline work would be like 350-400 injections and nw7 being a pretty rough 1800 plus pokes lol

Ouch.
Sounds no worse than the thousands of cuts made during a transplant though.

[CAlex]

Based on the original trial data they were able to get hair to grow about 2mm from the injection site.

Im estimating based on that. Id say about 9 injections per cm2

we really havent been informed if in the latest phase the new growth area increased in terms of how far from the injection site new growth was seen plus it is a definite possibility that multiple injections over larger surface ares could have a ripple like effect and help increase growth from the origin point.

@2020 I wouldn't really be worried about uneven growth. I hope people here aren't naive to believe this will be a one shot deal. Im sure most people would opt for top up procedures to increase density or to readdress areas where growth looks sporadic.

I think hairline work would be like 350-400 injections and nw7 being a pretty rough 1800 plus pokes lol

[2020]

Why is that? why would it be bad if it was over 20 injections?

as I said, it would be very hard to apply that growth EVENLY if the injection radius is very small. Results won't look good and less surgeons will take up on it

[Smiley]

much worse so it would be very bad if the number of injections needed over entire head(female market) is over 20.....

Why is that? why would it be bad if it was over 20 injections?

[2020]

It might be a very time consuming task, like a ht maybe?

much worse so it would be very bad if the number of injections needed over entire head(female market) is over 20.....

[Smiley]

They would have to charter hairloss flights.

Haha..for sure. Asia would be invaded!

yes but it will be extremely hard to distribute all that growth evenly if it only spreads over 2mm.....

It might be a very time consuming task, like a ht maybe?