Very nice thanks for the info!
Dr Lauster's Team (Berlin University of Technology)
Collapse
X
-
Hello my balding friends,
I have some news for you:
A couple days ago I asked Dr. Linders new company "Tissuse" how their work on hair follicels is going on and what they are planning to do next.
(Dr. Lindner is one of the Dr. Lauster / TU Berlin guys and Tissuse is the company that will commercialize TU Berlins work)
I was told that they are currently planning first "in-man-trials" - they also gave me Dr. Lindners email adress if I had more questions - so maybe we can collect some?!
yes, let's collect some questions.Comment
-
Are they planning on running trials in Japan with the new legislation that would allow conditional commercialization during Phase II trials?Comment
-
Comment
-
one additional thought: both germany and japan have high medical standards and i assume the general procedure for clinical trials is almost the same beside the new exception for earlier commercial release in japan.
so, would they need to do additional trials in japan, or is it sufficient to conduct the trials in germany and use them as basis for japan without conducting new trials over there?
because then, if they see that the treatment is successful in the early phases, they could simply decide to market it in japan without additional costs and wasted time. of course they would have to find a partner in japan which would offer the treatments, if they are not willing to set up a clinic on their own.Comment
-
Wow your ignorance is remarkable. This numbers are nowhere near correct.Comment
-
Comment
-
I am NOT a troll. I have a valid point, I think. Let me elaborate:
1. They are just preparing to start human trials. There are 3 phases to trials. Each trial takes at least 1 year so that means the trials will take at least 3 years. Also in-between each trial there is a 6-9 month period where scientists go over all of the date from the preceding trial so they can collect all information in great deal. Since there are 3 trials there will be 3 six to month periods where they are collecting information from the preceding trial. That means a total of at least 18 months for data collection. Then they will submit all of the information to regulatory agencies, which take about 6 months to one year to render a decision if the treatment is approved or not. If the treatment is approved it will take an additional few months to roll the treatment out for commercialization. If you add all of this time up it is about 5 years, and this is if there is no bumps in the road. Hence I think it will take at least 5 years to get this treatment to market.
2. That is even if it comes to market. It is possible that this treatment will not work well in humans in phase 1. Look how the Aderans treatment didn’t do well so the treatment was abandoned and scientists have gone back to the drawing board. It happens. It is not trollish of me to suggest that it could happen with the Berlin follicles trials.
3. I understand that the German team could ask Japan to release the treatment early but there are two concerns regards to that:
a) Japan might say no
b) The german team might not make the request to Japan
c) The treatment (implanting whole follicles) might not even meet the guidelines set by Japan. Japan said they could release cell treatments early but the German team are working with whole follicles, not cells. So it is possible that Japan might deny early approval because the treatment doesn’t even fit the criteria of being a cellular implant in order to get early approval.
4. Costs! A hair transplant is thousands and thousands of dollars. And in hair transplants they rather easily harvest donor material from the back of the patient’s own head. With the German team’s method the doctor will now have to make follicles from scratch in a lab. This is going to be way more complex and involved than a regular hair transplant so it is going to cost more, maybe a lot more, than a regular hair transplant.
There is nothing trollish or unreasonable about me pointing these issues out to the posters here. I understand that people don’t want to hear bad news but I think the issues I’m raising are valid. Please stop calling me a troll unfairly. I’m not trying to depress people; I’m just trying to evaluate these things honestly rather than sugar-coating things.
Arishi in particular calling me a troll is inappropriate because based on some 2014 HLC abstracts he previously he told us all that they had resolved the trichogencity issue, I said that the information in the abstracts did not say that, he called me a troll, and then I turned out to be correct.
Also, I wish to point out that not even one patient has used the German method yet. Not even one. We have no idea how this will play out in human testing.
I'm getting a raw deal when I'm called a troll. I'm just being honest.Comment
-
I believe a question should be, what do we have to do to get one of our forum members in the trial?
It would give us a lot of visibility and they could potentially benefit from the publicity of one of the biggest balding communities out there + one lucky fellow could get some extra hairsComment
-
I believe a question should be, what do we have to do to get one of our forum members in the trial?
It would give us a lot of visibility and they could potentially benefit from the publicity of one of the biggest balding communities out there + one lucky fellow could get some extra hairsComment
-
however, i like the idea. maybe dr. Lindner will keep it more transparent, at least in case of positive results. I think it could be worth a try. Just ask him what he would think about the idea of having a forum member in the trial. maybe his answer will be surprisingly positiveComment
-
probably true.
however, i like the idea. maybe dr. Lindner will keep it more transparent, at least in case of positive results. I think it could be worth a try. Just ask him what he would think about the idea of having a forum member in the trial. maybe his answer will be surprisingly positive
This probably holds true for other members as they are likely on meds themselves.Comment
-
Question:
- Would it be possible to learn about how such a trial is conducted and how they measure results? How long will the safety-trial be? What percentages of growth does he personally expect(just predictions of course)?
AND:
As mentioned before. Would it be possible to conduct phase 2 studies in Japan? Have they already thought about this? How are the regulations in Germany?Comment
Comment