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It’s official! I’m volunteering again to attend the next Hair Congress. This year it’s in Kyoto Japan from October 31st until Friday, November 3rd 2017 and if any of you have been paying attention to the news with Dr. Tsuji in Japan, you'll know this is an incredibly exciting time.
https://www.hairlosstalk.com/news/conferences/send-hellouser-10th-world-congress-japan/
Like last time, I’ve setup another GoFundMe page which can be found here:
https://www.gofundme.com/hair-congress-2017
Funds will cover the cost of the flight which might be up to $2,000 CAD to Japan, train ride from Tokyo to Kyoto (about $400 CAD) entrance fee to the congress which is about $1000 CAD (depends when I register) and about 5 or so nights hotel stay. I'll need to arrive on around October 29th or 30th at the latest. Japan is a long flight from Toronto, Canada and last time I went I had a lot of anxiety on the way there; couldn’t sleep the night before, didn’t sleep on the flight… by the time I got to my hotel I passed out and slept for about 14 straight hours. Yes, I was nervous. In any case, getting there early also gives me some buffer space should something go horribly wrong. Also, GoFundMe takes a cut of the funds. I've still got some old equipment from the last congress, so we’re good on that front except for a small tripod, I might need to buy a really light/portable one (the one I have now is massive and heavy). This is of course HOPING that this year I’ll be able to record some footage during the presentations. In any case, the goal on the GoFundMe page is an absolute maximum. If I can score a good deal on a flight to Japan, I’ll be able to drop the final amount. Wherever I can save some coin I'll be dropping the goal as well.
ALSO:
If there are any extra donations, or if we can hit about double of what we need for myself, I’ll be bringing another community member with me to help out with stuff; recordings, interviews, attending all the presentations, etc. As you guys know, there is a LOT going on with the congress so any help I can get for this will help me a lot. It was impossible for me to attend all of the presentations last time, so I did as much as I could. Having someone with me would ensure we cover every single presentation.
Information about the congress can be found here:
https://www.congre.co.jp/wchr2017/greeting.html
Preliminary Program Schedule can be found here:
https://www.congre.co.jp/wchr2017/scientific_prog.html
As of April 7th, notable confirmed speakers are:
Dr. Luis Garza
Dr. Jerry Shapiro
Dr. Wilma Bergfeld
Dr. Claire Higgins
Dr. Won Soo Lee
Dr. Rodney Sinclair
------------------------------------------------------------------------------------------------------------------------------------
Post your questions!
Last time we collected questions from forum members for the researchers. Please state your question and to whom the question is for. I'll need these by late October. I’ll be using my phone with a checklist for each interview, worked great last time (Google Keep FTW). I’ll be updating this thread’s first reply with all questions geared towards each researcher. I’ll do my best to get interviews with all of them. The list of researchers is a little short for now, but I’m sure it will pick up (there’s a LONG way to go until we get to the end of October anyway).
Questions for Tsuji Team (Ko-ei Toyoshima):
1. Average hair density for non balding adults is 200-300 hair shafts/cm^2, according to this http://www.keratin.com/aa/aa014.shtml and the internet in general.
Do they believe their germ method can achieve densities of 250 hair shafts/cm^2 or more without rejection/complications and if they don't know do they plan to experiment with such densities in the trials?
2. Could you please give us an update on your timeline for clinical trials and commercialization? It is our understanding that clinical trials are planned to commence in March of 2017 and commercialization is planned in 2020? Is this still the case? Is there a specific month or quarter within 2020 that you're targeting for market release?
^Really want to get an idea of when exactly within 2020 they're aiming for.
3. Many members are interested in traveling to Japan to receive the treatment once it's released. Knowing it will be expensive, people are trying to start saving now and are trying to plan for the future costs they will have to incur. In a 2016 interview, your team was not comment on the future cost of the procedure? Would you be able to provide an estimate or range of the cost, even though it may not be exact? (e.g. $35K - $65K)
^I would be prepared to push on this slightly and and emphasize the 'range' in case they say they're not exactly sure.
4. Your team stated in an interview that in the first year of release, about 10,000 people will be treated. There are eager forum members that are determined to make sure they receive a spot to be treated in the first year. Is there anything they can do to ensure they secure a spot?
5. Does your team foresee being able to replicate the density of that of a normal non-balding human in a single injection session? (~200 hairs per cm2)
6. How large is the graft to be taken from the back of the head?
7. Is it possible that some components of the timeline might move faster than originally planned for, and if that might speed up the time to get to market.
For example, right now Tsuji is testing human cells to see if he can get his expansion method to work in human cells. It's not a formal study. It's probably just some small basic study just to do the expansion and then test the cells for inductivity. Later they would test the process by injecting the cells into human scalps. Anyway, Tsuji has probably allowed 6 months to a year to do this small human cell testing because he probably figures he'll have to make repeated attempts and maybe make changes as he goes along. But what if the test quickly goes smoothly and he ends up only needing a couple months to get the desired result? That could save 6 months or so. So this is the kind of thing I'm interested in. My question is whether it's possible that the time to get to market could be shortened if some parts of the timeline process turn out to be less time consuming than first anticipated?
8. Will foreigners have access to these treatments once they are launched in Japan?
9. Is there any possibility that things could go extraordinarily well with this present testing and the testing could wrap up substantially sooner than anticipated? And if that's possible could that speed up the time to get the treatment to market?
10. Tsuji said that people with DUPA are out of luck, but sometimes DUPA people end up as Norwood 7 as well, just with a thin donor region. Can they also not gain a benefit from the treatment, even if it results in sparse hair coverage (better than nothing)?
11. And what are Tsuji-san's thoughts on people with retrograde alopecia? Will they also be eligible for treatment?
More generally, what is the cut off for donor quality/region that needs to be covered to give eligibility?
12. Finally, is hair direction controlled by the treatment, or does it self-assemble (hairs communicating to each other). I recall that Tsuji-san mentioned the former, but it doesn't explain the effect of the latter, which I've seen a lot of conversation about also.
13. Will you have a program for US/European medical tourism? Do you plan to have a system for us to ship our biopsies to their facilities and then fly over there in a few weeks when the culturing is done, so that outsiders can get the treatment? This would avoid staying in Japan for 3 weeks and there probably aren't strict rules to getting biopsies in USA/Canada/Europe?
14. Do you have opportunities for investors either directly or through licensing agreements with independent cell culture labs.
15. Your groundbreaking work in organ regeneration is set to be one of the most important contributions made to humanity in history. You research will ease so much suffering across the globe and into the future, revolutionising modern medicine and health care...
However, given the very real threat of nuclear war in the region, there is concern that the progress you have made could potentially be interrupted, or even worse lost forever..
Given the importance of your work, have any failsafes been put in place to safeguard your scientific findings and methods? It would be a catastrophic shame if nuclear war broke out, and doubly catastrophic if that caused the loss of your invaluable knowledge."
It is a dreadful thing for 'stupidity and hostility' to threaten 'genius and and compassion'.
“The four islands of the archipelago should be sunken into the sea by the nuclear bomb of Juche. Japan is no longer needed to exist near us,” the committee said in a statement carried by the North’s official KCNA news agency.
16. How definitive is the statement about only treating 10.000 people the first year?
17. What about the arrector pili muscles? These have been demonstrated to degrade with the progression of Androgenetic Alopecia and have also been known to serve a crucial role in the hair follicular unit. Will these be regenerated as well when the follicle primordia are injected under the scalp? How? Will they be resuscitated or will new AP form? In either case, how will the follicle unit "merge" with the AP? Or does something else happen? If new AP grow, will that influence the hair growth direction then, since AP alignment and hair alignment naturally coincide?
18. When you take a sample from the scalp, how would they know which areas to avoid? What if the accidentally sample hair from regions that have not miniaturized just yet, but are destined to do so shortly. For example, for those of us who bald through a receding hairline. The hair behind the recession front is still fairly thick, but we know it is doomed. Are there microscopic cues that can inform them which follicles to avoid (within the donor region, obviously)? Asking just in case thinning is destined to extend into the donor region also.
19. When will clinical trials start?
Questions for Kerastem:
1. In regards to Kerastem's phase 2 trial, the trial started in late September 2016 and test subjects were going to be observed for 12 months. Is there any available data or news about the trials now that the trial has had more than 12 months?
2. Is Kerastem considering asking the FDA for early market release after phase 2?
Questions for Replicel/Shiseido (Ryoji Tsuboi):
1. Did you somehow "upgrade/improve" RCH-01 since you got the permission from Replicel to develop it further?
2. İs it still possible to get "new" hair from this procedure or just get thinner and minituarized back?
İf yes could this also be possible for the donor area of hair transplant patients?
3. Could the results be improved by getting multiple injections?
4. For how long do the treated hairs get immunized?
5. Are you still planning to release at the end of 2018?
6. Will you have a program for US/European medical tourism? Do you plan to have a system for us to ship our biopsies to their facilities and then fly over there in a few weeks when the culturing is done, so that outsiders can get the treatment? This would avoid staying in Japan for 3 weeks and there probably aren't strict rules to getting biopsies in USA/Canada/Europe?
7. Have you seen good regrowth in clinical trials?
8. Will Shiseido establish a medical tourism channel, are there any details already available on the agreement between Replicel and Shiseido? Is it considered "cheating" to service customers from US/EU when their agreement gives Shiseido the right to sell in Asia only?
Questions for Follica (Dr. Cotsarelis / Dr. Washenik):
1. Does Follica's method of wound induced follicle neogenesis take into consideration the direction of the new follicle and hair fibre that grows or will it take on the pattern of the previous hair before the balding state?
2. How does Follica's treatment affects the AP muscle? When we bald, it degrades, correct? Do the new follicles link up to the old AP? Do they regenerate their own AP? Is the old AP rejuvinated? Do the new follicles not need an AP? As far as I know, the AP sets the hair direction, or at the very least, the AP and native hair share the same alignment. Of course the AP is an integral part of the FU health so that's why I am concerned about it.
3. Are the new follicular units producing up to 4 hairs? Or is it just the primary hair?
4. Would it be possible to ask him if the new hair that grows with Follica is DHT resistant? How does he know? Does the mechanism make sense?
5. And do they have any plans for scale up in place already? Have they decided which clinics will first begin offering treatment? Is there an estimate for the launch date?
6. Can you reveal anything about the status of their final trial? Any indication as to if they're really on track for first half of 2018 pivotal trials?
7. How deep and which layers of epidermis your skin disruption will reach ? Is there any down time (just like after a surgery) ? Does your protocol avoid damaging existent hairs and prevent any form of scarring ? In general, what kind of wound should we expect ?"
8. Can this protocol or a similar one be use for other cosmetic issues like scar revision ?
Questions for Dr. Claire Higgins:
1. What is the status of HairClone?
Questions for Dr. Jeffrey Biernaskie:
1. What do you think about the potential for in vitro stem cell multiplication to lead to cancer cells which might be implanted into the scalp.
It has been demonstrated in studies that in vitro stem cell multiplication may lead to deregulation of cells causing cancers to develop. When cells multiply in the body, there are checks and balances to fix errors and destroy damaged cells that don't exist when multiplying in vitro.
I wonder whether they have any ideas for how this could be monitored or assessed before re-implantation into the scalp occurs.
Spontaneous malignant transformation of mouse MSC following long term in vitro culture has been described [55-57]. Also spontaneous transformation of mice neural precursor/stem cells has been reported [58]. These transformed cells were detected already after ~10 passages of cell culture, and produced tumours in vivo upon administration into rodent brains.
This is critically important as more and more guys are turning to the stem cell research teams like Replicel with their hopes and if even one case leads to tumor formation it is going to be catastrophic.
We need safety mechanisms in place (or at least discussion of the risk) to potentially prevent any horrifying outcomes.
Questions for Dr. Gerd Lindner:
1. Have they found the funding they need to proceed into clinical trials?
2. What would be the time frame for completing clinical trials through EMA in Europe.
-----------------------------------------------------------------------------------------------------
***UPDATE: Oct. 25 ***
Posters have been made public! Here's the list:
https://www.congre.co.jp/wchr2017/data/poster.pdf
Oral presentations also announced:
https://www.congre.co.jp/wchr2017/data/oral.pdf
And the full Program (though I have a feeling it might change a little):
https://www.congre.co.jp/wchr2017/data/program_at_a_glance8.pdf
https://www.hairlosstalk.com/news/conferences/send-hellouser-10th-world-congress-japan/
Like last time, I’ve setup another GoFundMe page which can be found here:
https://www.gofundme.com/hair-congress-2017
Funds will cover the cost of the flight which might be up to $2,000 CAD to Japan, train ride from Tokyo to Kyoto (about $400 CAD) entrance fee to the congress which is about $1000 CAD (depends when I register) and about 5 or so nights hotel stay. I'll need to arrive on around October 29th or 30th at the latest. Japan is a long flight from Toronto, Canada and last time I went I had a lot of anxiety on the way there; couldn’t sleep the night before, didn’t sleep on the flight… by the time I got to my hotel I passed out and slept for about 14 straight hours. Yes, I was nervous. In any case, getting there early also gives me some buffer space should something go horribly wrong. Also, GoFundMe takes a cut of the funds. I've still got some old equipment from the last congress, so we’re good on that front except for a small tripod, I might need to buy a really light/portable one (the one I have now is massive and heavy). This is of course HOPING that this year I’ll be able to record some footage during the presentations. In any case, the goal on the GoFundMe page is an absolute maximum. If I can score a good deal on a flight to Japan, I’ll be able to drop the final amount. Wherever I can save some coin I'll be dropping the goal as well.
ALSO:
If there are any extra donations, or if we can hit about double of what we need for myself, I’ll be bringing another community member with me to help out with stuff; recordings, interviews, attending all the presentations, etc. As you guys know, there is a LOT going on with the congress so any help I can get for this will help me a lot. It was impossible for me to attend all of the presentations last time, so I did as much as I could. Having someone with me would ensure we cover every single presentation.
Information about the congress can be found here:
https://www.congre.co.jp/wchr2017/greeting.html
Preliminary Program Schedule can be found here:
https://www.congre.co.jp/wchr2017/scientific_prog.html
As of April 7th, notable confirmed speakers are:
Dr. Luis Garza
Dr. Jerry Shapiro
Dr. Wilma Bergfeld
Dr. Claire Higgins
Dr. Won Soo Lee
Dr. Rodney Sinclair
------------------------------------------------------------------------------------------------------------------------------------
Post your questions!
Last time we collected questions from forum members for the researchers. Please state your question and to whom the question is for. I'll need these by late October. I’ll be using my phone with a checklist for each interview, worked great last time (Google Keep FTW). I’ll be updating this thread’s first reply with all questions geared towards each researcher. I’ll do my best to get interviews with all of them. The list of researchers is a little short for now, but I’m sure it will pick up (there’s a LONG way to go until we get to the end of October anyway).
Questions for Tsuji Team (Ko-ei Toyoshima):
1. Average hair density for non balding adults is 200-300 hair shafts/cm^2, according to this http://www.keratin.com/aa/aa014.shtml and the internet in general.
Do they believe their germ method can achieve densities of 250 hair shafts/cm^2 or more without rejection/complications and if they don't know do they plan to experiment with such densities in the trials?
2. Could you please give us an update on your timeline for clinical trials and commercialization? It is our understanding that clinical trials are planned to commence in March of 2017 and commercialization is planned in 2020? Is this still the case? Is there a specific month or quarter within 2020 that you're targeting for market release?
^Really want to get an idea of when exactly within 2020 they're aiming for.
3. Many members are interested in traveling to Japan to receive the treatment once it's released. Knowing it will be expensive, people are trying to start saving now and are trying to plan for the future costs they will have to incur. In a 2016 interview, your team was not comment on the future cost of the procedure? Would you be able to provide an estimate or range of the cost, even though it may not be exact? (e.g. $35K - $65K)
^I would be prepared to push on this slightly and and emphasize the 'range' in case they say they're not exactly sure.
4. Your team stated in an interview that in the first year of release, about 10,000 people will be treated. There are eager forum members that are determined to make sure they receive a spot to be treated in the first year. Is there anything they can do to ensure they secure a spot?
5. Does your team foresee being able to replicate the density of that of a normal non-balding human in a single injection session? (~200 hairs per cm2)
6. How large is the graft to be taken from the back of the head?
7. Is it possible that some components of the timeline might move faster than originally planned for, and if that might speed up the time to get to market.
For example, right now Tsuji is testing human cells to see if he can get his expansion method to work in human cells. It's not a formal study. It's probably just some small basic study just to do the expansion and then test the cells for inductivity. Later they would test the process by injecting the cells into human scalps. Anyway, Tsuji has probably allowed 6 months to a year to do this small human cell testing because he probably figures he'll have to make repeated attempts and maybe make changes as he goes along. But what if the test quickly goes smoothly and he ends up only needing a couple months to get the desired result? That could save 6 months or so. So this is the kind of thing I'm interested in. My question is whether it's possible that the time to get to market could be shortened if some parts of the timeline process turn out to be less time consuming than first anticipated?
8. Will foreigners have access to these treatments once they are launched in Japan?
9. Is there any possibility that things could go extraordinarily well with this present testing and the testing could wrap up substantially sooner than anticipated? And if that's possible could that speed up the time to get the treatment to market?
10. Tsuji said that people with DUPA are out of luck, but sometimes DUPA people end up as Norwood 7 as well, just with a thin donor region. Can they also not gain a benefit from the treatment, even if it results in sparse hair coverage (better than nothing)?
11. And what are Tsuji-san's thoughts on people with retrograde alopecia? Will they also be eligible for treatment?
More generally, what is the cut off for donor quality/region that needs to be covered to give eligibility?
12. Finally, is hair direction controlled by the treatment, or does it self-assemble (hairs communicating to each other). I recall that Tsuji-san mentioned the former, but it doesn't explain the effect of the latter, which I've seen a lot of conversation about also.
13. Will you have a program for US/European medical tourism? Do you plan to have a system for us to ship our biopsies to their facilities and then fly over there in a few weeks when the culturing is done, so that outsiders can get the treatment? This would avoid staying in Japan for 3 weeks and there probably aren't strict rules to getting biopsies in USA/Canada/Europe?
14. Do you have opportunities for investors either directly or through licensing agreements with independent cell culture labs.
15. Your groundbreaking work in organ regeneration is set to be one of the most important contributions made to humanity in history. You research will ease so much suffering across the globe and into the future, revolutionising modern medicine and health care...
However, given the very real threat of nuclear war in the region, there is concern that the progress you have made could potentially be interrupted, or even worse lost forever..
Given the importance of your work, have any failsafes been put in place to safeguard your scientific findings and methods? It would be a catastrophic shame if nuclear war broke out, and doubly catastrophic if that caused the loss of your invaluable knowledge."
It is a dreadful thing for 'stupidity and hostility' to threaten 'genius and and compassion'.
“The four islands of the archipelago should be sunken into the sea by the nuclear bomb of Juche. Japan is no longer needed to exist near us,” the committee said in a statement carried by the North’s official KCNA news agency.
16. How definitive is the statement about only treating 10.000 people the first year?
17. What about the arrector pili muscles? These have been demonstrated to degrade with the progression of Androgenetic Alopecia and have also been known to serve a crucial role in the hair follicular unit. Will these be regenerated as well when the follicle primordia are injected under the scalp? How? Will they be resuscitated or will new AP form? In either case, how will the follicle unit "merge" with the AP? Or does something else happen? If new AP grow, will that influence the hair growth direction then, since AP alignment and hair alignment naturally coincide?
18. When you take a sample from the scalp, how would they know which areas to avoid? What if the accidentally sample hair from regions that have not miniaturized just yet, but are destined to do so shortly. For example, for those of us who bald through a receding hairline. The hair behind the recession front is still fairly thick, but we know it is doomed. Are there microscopic cues that can inform them which follicles to avoid (within the donor region, obviously)? Asking just in case thinning is destined to extend into the donor region also.
19. When will clinical trials start?
Questions for Kerastem:
1. In regards to Kerastem's phase 2 trial, the trial started in late September 2016 and test subjects were going to be observed for 12 months. Is there any available data or news about the trials now that the trial has had more than 12 months?
2. Is Kerastem considering asking the FDA for early market release after phase 2?
Questions for Replicel/Shiseido (Ryoji Tsuboi):
1. Did you somehow "upgrade/improve" RCH-01 since you got the permission from Replicel to develop it further?
2. İs it still possible to get "new" hair from this procedure or just get thinner and minituarized back?
İf yes could this also be possible for the donor area of hair transplant patients?
3. Could the results be improved by getting multiple injections?
4. For how long do the treated hairs get immunized?
5. Are you still planning to release at the end of 2018?
6. Will you have a program for US/European medical tourism? Do you plan to have a system for us to ship our biopsies to their facilities and then fly over there in a few weeks when the culturing is done, so that outsiders can get the treatment? This would avoid staying in Japan for 3 weeks and there probably aren't strict rules to getting biopsies in USA/Canada/Europe?
7. Have you seen good regrowth in clinical trials?
8. Will Shiseido establish a medical tourism channel, are there any details already available on the agreement between Replicel and Shiseido? Is it considered "cheating" to service customers from US/EU when their agreement gives Shiseido the right to sell in Asia only?
Questions for Follica (Dr. Cotsarelis / Dr. Washenik):
1. Does Follica's method of wound induced follicle neogenesis take into consideration the direction of the new follicle and hair fibre that grows or will it take on the pattern of the previous hair before the balding state?
2. How does Follica's treatment affects the AP muscle? When we bald, it degrades, correct? Do the new follicles link up to the old AP? Do they regenerate their own AP? Is the old AP rejuvinated? Do the new follicles not need an AP? As far as I know, the AP sets the hair direction, or at the very least, the AP and native hair share the same alignment. Of course the AP is an integral part of the FU health so that's why I am concerned about it.
3. Are the new follicular units producing up to 4 hairs? Or is it just the primary hair?
4. Would it be possible to ask him if the new hair that grows with Follica is DHT resistant? How does he know? Does the mechanism make sense?
5. And do they have any plans for scale up in place already? Have they decided which clinics will first begin offering treatment? Is there an estimate for the launch date?
6. Can you reveal anything about the status of their final trial? Any indication as to if they're really on track for first half of 2018 pivotal trials?
7. How deep and which layers of epidermis your skin disruption will reach ? Is there any down time (just like after a surgery) ? Does your protocol avoid damaging existent hairs and prevent any form of scarring ? In general, what kind of wound should we expect ?"
8. Can this protocol or a similar one be use for other cosmetic issues like scar revision ?
Questions for Dr. Claire Higgins:
1. What is the status of HairClone?
Questions for Dr. Jeffrey Biernaskie:
1. What do you think about the potential for in vitro stem cell multiplication to lead to cancer cells which might be implanted into the scalp.
It has been demonstrated in studies that in vitro stem cell multiplication may lead to deregulation of cells causing cancers to develop. When cells multiply in the body, there are checks and balances to fix errors and destroy damaged cells that don't exist when multiplying in vitro.
I wonder whether they have any ideas for how this could be monitored or assessed before re-implantation into the scalp occurs.
Spontaneous malignant transformation of mouse MSC following long term in vitro culture has been described [55-57]. Also spontaneous transformation of mice neural precursor/stem cells has been reported [58]. These transformed cells were detected already after ~10 passages of cell culture, and produced tumours in vivo upon administration into rodent brains.
This is critically important as more and more guys are turning to the stem cell research teams like Replicel with their hopes and if even one case leads to tumor formation it is going to be catastrophic.
We need safety mechanisms in place (or at least discussion of the risk) to potentially prevent any horrifying outcomes.
Questions for Dr. Gerd Lindner:
1. Have they found the funding they need to proceed into clinical trials?
2. What would be the time frame for completing clinical trials through EMA in Europe.
-----------------------------------------------------------------------------------------------------
***UPDATE: Oct. 25 ***
Posters have been made public! Here's the list:
https://www.congre.co.jp/wchr2017/data/poster.pdf
Oral presentations also announced:
https://www.congre.co.jp/wchr2017/data/oral.pdf
And the full Program (though I have a feeling it might change a little):
https://www.congre.co.jp/wchr2017/data/program_at_a_glance8.pdf
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