Who is this guy? 'Hair follicles made ex vivo that can be inserted..'

[Slam1523]

Very good questions indeed. The 21st Century cure act and the Japan stem cell trials still require 2 phases of trials before entering the market. Depending on how complex a procedure is 2 phases of trials generally takes 5-7 years.

Phase 1 safety trial is tested on 10-20 healthy volunteers and generally takes 1 year + 6-12 months for regulatory approval of the trial, the approvals needed form the Ethics committees and subject recruitment etc.

If all goes well, one to two separate Phase 2 trials also needs to be conducted on ~ 300 patients suffering from AGA. A "Proof of Concept" trial (Phase 2a) and a "Dose-range finding" trial (Phase 2b) which generally takes approximately 3 years. Again this process needs to be approved by regulatory bodies before and after the completion of trials. Now if we add in the time for patient recruitment and regulatory processes, Phase 2 generally takes 4-5 years.

So overall, the minimum it takes to go from successful Laboratory work to patients is going to be 6 years.

With regards to your second question, all of this red tape exists because even though they are expanding our own cells and re-implanting them, these cells are placed into growth factors sourced from cows, pigs or other humans. This brings in a whole lot of risks from possibility of carcinogenicity, as well as altering the behaviour of the original cells necessitating the level of caution that is practiced in the field of organ regeneration.

Hope that helps brother

Yep thanks for the explanation! I appreciate it!

[lacazette]

Hey Desmond, I think your timeline is the right one regarding 21st century cure.

But with japan's new laws, it's different,

" Japan's new policy requires an early stage clinical trial (call it a Phase I or small Phase II) at the minimum to confirm safety of the therapy and provide some plausible evidence of efficacy. Rather than requiring that the therapy then be evaluated in subsequent trials before making it available to patients, Japan's new law will allow for a "conditional approval" enabling the product to be brought to market, and for the product to obtain reimbursement in an accelerated manner. "
http://www.marketwatch.com/story/jap...-be-2014-03-03

Indeed the laws will redesign phase 1 and 2, with earlier detection and evaluation of safety, and the confirmation of probable benefit with a smaller number of patient

As I understand conditionnal approval there will be possible with a big phase 1 or a small phase 2, or and so during the big phase 2.

I read a scientific interview ( i have to refind where) where a japanese PhD explained that their main goal with their new initiatives regarding stem cell therapies, is to shorten the timeline between preclinical potential treatments and access for the public, and passed from 7-10 years to 2-3 years

[joachim]

Hey Desmond, I think your timeline is the right one regarding 21st century cure.

But with japan's new laws, it's different,

" Japan's new policy requires an early stage clinical trial (call it a Phase I or small Phase II) at the minimum to confirm safety of the therapy and provide some plausible evidence of efficacy. Rather than requiring that the therapy then be evaluated in subsequent trials before making it available to patients, Japan's new law will allow for a "conditional approval" enabling the product to be brought to market, and for the product to obtain reimbursement in an accelerated manner. "
http://www.marketwatch.com/story/jap...-be-2014-03-03

Indeed the laws will redesign phase 1 and 2, with earlier detection and evaluation of safety, and the confirmation of probable benefit with a smaller number of patient

As I understand conditionnal approval there will be possible with a big phase 1 or a small phase 2, or and so during the big phase 2.

I read a scientific interview ( i have to refind where) where a japanese PhD explained that their main goal with their new initiatives regarding stem cell therapies, is to shorten the timeline between preclinical potential treatments and access for the public, and passed from 7-10 years to 2-3 years

i think you're right with what you wrote. japan allows conditional release of new treatments DURING phase 2 with their new laws. so 2-3 years might indeed be possible in japan.
nobody should take the FDA route as long as it is a mess. even 6-7 years is way too long.

i think, japan's new laws are perfect. conditional release during phase 2 allows companies to make money by selling a product already, and at the same time collecting more safety data about the product.

i hope more and more companies will go that route through japan. most companies probably aren't even aware of japan's huge impact yet.

the FDA should be avoided. the new cure act is nice and welcome, but it's still far from useful. the FDA should learn the hard way.

[xyz123]

A good example is actually Replicel.

They began the Phase 1 trials in 2011 and are expecting to complete the Phase 2 trials by 2018. This whole process will take approximately 7 years! It's a long time to be fair but at least you have a peace of mind knowing the procedure is going to be safe.

Thanks Desmond - your posts are always really helpful.

I would argue, however, that if a legitimate cure is developed - it would likely come to market much more quickly. If images of a treatment converting a NW6 to a NW1 were released, there would be massive pressure (from the public) and impetus (from the company) to move things forward as rapidly as possible. I think the time lag would be limited only by the duration of follow-up required in each trial.

Unlike most things in science and medicine, there would essentially be unlimited funding given that a cure is so lucrative (I completely agree with your comment - when a real solution arrives, funding will not be an issue) - so there would be no delay between trials. Recruitment for each trial would likely be accomplished within weeks as there would be millions of people lining up for the treatment (which is a stark contrast from most trials when investigators are desperately seeking out study participants). And regulatory approval would be expedited. Can you imagine the public's reaction to seeing hundreds of previously bald people now with thick NW1 heads of hair being profiled on the nightly news - and then being told - "yes, the treatment works - however the FDA is now going to take 1 year to carefully review everything before providing approval". No chance - given the public demand and industry pressure, the treatment would be likely be approved in a fraction of the regular time.

When a real solution is found - I really believe things will come together very quickly. To date, the problem has been that nothing has worked well, so there has been limited motivation to move things forward. Replicel is a great example. After their Phase 1 results, Phase 2 was supposed to start in 2012. But the Phase 1 results were extremely modest (and in no way resembled a cure) - so there was limited funding and little motivation to move things forward. And now in mid-2015, we are still waiting for Phase 2 to start (and without Shiseido, it may have never started...). Same goes for Histogen - modest results that didn't excite the public and efforts stalled. Had either of these therapies resulted in dramatic results, they would be on the market right now. When the real cure comes, I really believe that things will happen quickly - still on the order of years - but more like 2-3, rather than 5-7.

Just my two cents - or at least that's what I want to believe

[dutchguyhanging]

never understood why people talk about timelines or duration of each phases. I mean why do you care? Show pics of the transformation say NW7 to NW1. then lets all discuss how things can speed up. why worrying about nuisances yet we dont have a full blown cure.

[lacazette]

I repost Dr.Fabrikant offices numbers, If someone fluent could call just to ask if he works on his 3D 'lab made' hair, or if it's still just a patent? or If there's any preclinical testing collaboration, etc?

No one in US or with fluent oral english who is interested to get these infos? If so please help the community hehe

Dr. Jordan S. Fabrikant, DO
Office locations:

Skin & Cancer Associates
4308 Alton Rd Ste 510
Miami Beach, FL 33140
Phone: (305) 674-8865

2025 Indian Rocks Rd SLargo, FL 33774
(727) 586-7203 (Office)
(727) 585-7205 (Fax)

patent in page 1

[Renee]

They can't even make a folicle in the lab, I doubt they will be able to print. Our best hope is: lauster/Linder/atac, christiano/jahoda/Higgins, tsuji, terskikh, cotsraelis/xu. If you go to google patent lauster team filed a patent in dec 2014 after the congress, hopefully they have solved it now.

[Renee]

I got this from americanhairloss.org. Why isn't this available now??

Regenerative Science Being Used To Aid In Hair Regrowth
by JOHN FRANK, MD
Looking at stem cells as a cure for baldness is hardly new, but being able to bio-engineer a hair follicle from one’s own DNA would represent a significant new breakthrough – but that’s exactly what a team of researchers in genetic regenerative medicine and bio-engineering at Tokyo University have done.

Asakawa K, Toyoshima KE, Ishibashi N, Tobe H, Iwadate A, Kanayama T, Hasegawa T, Nakao K, Toki H, Noguchi S, Ogawa M, Sato A, & Tsuji T published work in Nature last May, 2012, demonstrating a technique whereby they’ve been able to bio-engineer functional hair follicles that exhibit a normal growth cycle from stem cells taken from existing hair follicles.

To demonstrate that the bio-engineered hair follicles functioned like real hair follicles, they employed a widely used hair transplant technique called follicle unit transplantation, or FUT, to transplant these bio-engineered hair follicles into the scalp of mice. Not only did the transplanted hair follicles exhibit the normal growth cycle of hair follicles, they also grew the correct type of hair and at the correct orientation as a function of the transplanted location.

In short, we can now, in principle, bio-engineer our own fully functional hair follicles based on our own DNA. When asked how soon a practical hair replacement treatment could come out of this work, the research team said they hoped clinical trials could begin within three to five years, and, if that happens, they think a practical bio-engineered based surgical hair replacement treatment procedure could exist within a decade.

[lacazette]

Is it the Tsuji that we know in this study?

Well if the research team were right, they're peraph's already in beginning trial from now, or begin soon (1/2y), then with regenerative laws in japan that could sound good before 2020.

But who's that team? let's try to find if they're still in the game.


For your first post renee, bioprinting cells are solving some previous issues researchers had regarding the hair regeneration

[Renee]

Yes it's the tsuji we know. Do u know if he used adult cells? Or was it mouse cells?