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

[stratowich]

This guy is the owner of this recent patent... http://www.google.com/patents/US20150017131

Hi lacazette, just briefly wanted to add something to what Desmond said. A lot of people file/apply for patents, but that doesn't mean that they "hold/own" what is described in the patent application. For example, the link you posted in the beginning of this thread just describes a patent application. You can easily identify if a document is just an application or an actual patent by checking the end of the patent-number. A1 for example means that it's the first application of the patent, A2 means that it is the second application, and so on. Now, if the patent-number ends in B1 or B2, etc., that means that the person/company that applied for the patent actually holds the legal rights to the invention. However, almost all patent applications are not approved to be a patent. Not sure if there is a English wikipedia article that sums this all up, but here is at least the link to the German one:

https://de.wikipedia.org/wiki/Patentnummer

[joachim]

lacazette, a lot of great finds! well done man

[lacazette]

Hi lacazette, just briefly wanted to add something to what Desmond said. A lot of people file/apply for patents, but that doesn't mean that they "hold/own" what is described in the patent application. For example, the link you posted in the beginning of this thread just describes a patent application. You can easily identify if a document is just an application or an actual patent by checking the end of the patent-number. A1 for example means that it's the first application of the patent, A2 means that it is the second application, and so on. Now, if the patent-number ends in B1 or B2, etc., that means that the person/company that applied for the patent actually holds the legal rights to the invention. However, almost all patent applications are not approved to be a patent. Not sure if there is a English wikipedia article that sums this all up, but here is at least the link to the German one:
https://de.wikipedia.org/wiki/Patentnummer

Thanks you for the details Strato. I have questions, what is the process to hold the legal rights? and who approve the patent then?
And can he test his invention in pre clinical for ex before holding the rights?

Hey Joachim, i was searching bioprinting, and I found your topic about it https://www.baldtruthtalk.com/thread...io-3d-printing
The idea of a crowdfunding test was really interesting, you were searching for other bioprinter company to get infos
look at this great 3D bioprinter selling by Cyfuse Biomedical K.K. University of Tokyo Entrepreneur Plaza (that it is just waiting to be tried for hair follicle as we see in their animation haha)

http://www.cyfusebio.com/en/regenerative.html

Bio 3D Printer Regenova with Kenzan method

We provide the leading edge platform of three-dimensional organ regeneration using our revolutionary bio 3D printer, Regenova. Regenova is a novel robotic system that facilitates the fabrication of three- dimensional cellular structures by placing cellular spheroids in fine needle arrays, “Kenzan method”, according to pre-designed 3D data.

[stratowich]

Thanks you for the details Strato. I have questions, what is the process to hold the legal rights? and who approve the patent then?
And can he test his invention in pre clinical for ex before holding the rights?

It's usually a long process to get something patented, whether you're trying to get a new pharmaceutical patented or a plastic lid for your starbucks coffee. After you submit your patent application one or more patent reviewers (https://en.wikipedia.org/wiki/Patent_examiner) will examine previous patents and scientific publications and make sure that anything claimed in the application hasn't been described/published before anywhere else.

[Slam1523]

Of course once they are able to do that, it needs to undergo clinical trials for 5-7 years before it becomes commercially available to public.

Hypothetically if something does come at the Hair Congress this year, or even next year... Why wouldn't a team take this technology straight to japan in order to start providing it commercially sooner? I believe the USA will likely be introducing the 21st Century Cures Act by the beginning of next year once it passes, and if that happens things like this be allowed in the US sooner... I guess ultimately my question is this... Everyone seems to be on the train of creating hairs to be implanted, and from what I hear many believe that is the safest route to get a full head of hair back. If that is the case what exactly is it that has to go through the FDA, or other country's trials before it can pass safety measures? Sorry this may be a dumb question, but I was under the impression that if they were able to use our own cells to multiply our hairs that it wouldn't require any further safety testing because it is our own hair cells to start with...

[Renee]

Yes from what I have read and know that is safe method because you are using your own cells.

[lacazette]

To come back on topic:

February 21, 2014
"Larkin Community Hospital is extremely happy to congratulate our Chief Resident in Dermatology, Jordan Fabrikant, DO who was named the 2014 South Beach Dermatology Symposium National Champion in Dermatological Trivia this past weekend.
Dr. Fabrikant is interested in medical, surgical, and cosmetic Dermatology."

Now he seems to work with mount sinai miami center, he's a skin cancer, skin reconstruction specialist (Mohs surgery), so he's definitly not a joke

Nobody could call at his offices? To ask if he works on lab-made hair follicles? Or if it's just a patent application for the moment? and ask if he schedule a preclinical in future to test his protocol, etc?

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: http://www.google.com/patents/US20150017131

I could try myself, but I'm so bad at oral,even with pre writting questions, I will not understand the answers and won't be able to have a simple discussion/interaction with him or his assistant. So could someone with fluent English could take 5min and try it?

[lacazette]

I'm searching everywhere and I don't find any patent application regarding 3D 'ready to implant' hair follicles and methods to grow functional follicle ex vivo with 3D cells. ( except the parts regarding neogenesis in aderans and us army patents)

so this guy could be into something at least interesting, and maybe promising. 3D bioprinting is growing so fast

[Desmond84]

Hypothetically if something does come at the Hair Congress this year, or even next year... Why wouldn't a team take this technology straight to japan in order to start providing it commercially sooner? I believe the USA will likely be introducing the 21st Century Cures Act by the beginning of next year once it passes, and if that happens things like this be allowed in the US sooner... I guess ultimately my question is this... Everyone seems to be on the train of creating hairs to be implanted, and from what I hear many believe that is the safest route to get a full head of hair back. If that is the case what exactly is it that has to go through the FDA, or other country's trials before it can pass safety measures? Sorry this may be a dumb question, but I was under the impression that if they were able to use our own cells to multiply our hairs that it wouldn't require any further safety testing because it is our own hair cells to start with...

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

[Desmond84]

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.

[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/japans-bold-initiative-in-regenerative-medicine-and-who-the-big-winners-might-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/japans-bold-initiative-in-regenerative-medicine-and-who-the-big-winners-might-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.