21st Century Cures Act to Accelerate Medical Progress

21st Century Cures Act

— As expected, on November 30th the US House of Representatives passed the groundbreaking 21st Century Cures Act with a high level of bipartisan support. This Act has been discussed on hair loss forums fairly regularly over the past year since it would allow for faster times for hair loss drugs and stem cell therapies to come to market without the need for completion of extensive phase 3 clinical trials.

I think this development will prevent more western pharmaceutical, medical device and stem cell therapy related companies from moving research and development activities to countries such as Japan. A somewhat similar Act has already been passed in that country. There are still a lot of uncertainties on the final regulations, and the rules could always end up being stricter for products related to cosmetic conditions such as hair loss. Wired magazine calls this development “inject and see” and warns of the obvious dangers of such an approach for patients.

— I covered firefighter Pat Hardison and his groundbreaking full face transplant on this blog before. I did not realize that he also got a full new head of hair and not just a new face..

— On Twitter, Dr. Alan Bauman recently posted an unbelievable before and after photo of a hair loss patient who was treated with adipose-derived stem cells (ADSC). The photo was from a Boston Biolife led presentation at the recent World Stem Cell summit held in Florida in early December.

I contacted Boston Biolife and they said the doctor who made this presentation might send me the actual full presentation if I e-mailed him, but so far no response. I would normally consider such a great result from ADSC to be a scam or a one-time exceptional case that does not warrant too much discussion. However, I ended up including it here because the presentation was made at a seemingly reputable stem cell summit.

Adipose Derived Stem Cells Hair Growth
Adipose-Derived Stem Cells Hair Treatment

— On December 7th Aclaris Therapeutics announced that it had initiated phase 1 clinical trials for its ATI-50001 JAK inhibitor product to treat alopecia totalis and alopecia universalis. Also, in late November they had an earnings call, with the most relevant part pasted below:

“In addition to progressing our JAK treatment program for the treatment of alopecia areata and as we reported on our last call, we have initiated preclinical development of additional JAK inhibitors which we are developing for topical use both in vitiligo and androgenetic alopecia, which is also known as male or female pattern baldness. The program includes the development of ATI-5003, which is a covalently binding JAK3-specific inhibitor, and the preclinical and formulation work continue to progress as expected.”

— New study from Germany: “Hair follicle stem cell cultures reveal self‐organizing plasticity of stem cells and their progeny”.

Rafael Nadal gets a hair transplant.

And now on to medical items of interest:

World’s oldest woman turns 117 and credits an eggs and cookies diet combined with no husband.

— I covered the crazy skin gun video from 2011 on this blog before. After five years of waiting, it seemed like the concept was a fantasy and would never take off. Now the US based company that is behind this product, RenovaCare, has been awarded a patent for its skin gun technology. And they also got covered by CNN this month.

3D printed organs look, feel and bleed like the real thing.

Dementia (including Alzheimer’s) could soon be treatable. Or at least stabilized and manageable.

Mice lifespans extended by 30 percent and organs rejuvenated via reprogramming the genome. Actual study.

Some new information on Google’s Calico.

More good news on diabetes drug Metformin, which also helps with cancer treatment. This drug has been in use for over 60 years.

87 thoughts on “21st Century Cures Act to Accelerate Medical Progress”

    1. I actually believe it will believe it will come sooner. Middle of 2018. This is a safe long projection. 2020 is just to defray some of the legal unforeseen restrictions that may occur. Lobbyists are negotiating this at country clubs, golf courses, planes, saunas etcéteras. The technology is there! The right people have to get their cut before this is a marketable product.

  1. Some pretty interesting stuff here. I’m actually very impressed with ADSC injection treatment regrowth. If that is legit then that would cure me! I remember seeing a Korean research study done back in 2010 or something with similar results. The question is why isn’t this out in the market ? Why doesn’t kerastem produce anything similar? I guess this Boston doctor found the secret trick or ingredients to make it successful :)

    I’m glad to see they found a treatment for alzheimers and dementia. It’s a horrible disease and I hope this works well and available soon for those who need it. It’s almost 2017 and illnesses like this and especially baldness should be successfully treated if not cured. The future is now.

    1. Is ADSC the same thing as the STYLE clinical trial going on in the US by kerastem or what have you? Also jonesy, the future and year we are in is all relative and makes little sense when you think about why “now” is any more of a revolutionary time as opposed to everything else that was revolutionary in the past or to come in the future. Nothing is special about 2017, 2018 or whatever. MERRY CHRISTMAS…Trump won the war on christmas btw…what a joke. I’m going to make that peasant my whipping boy.

  2. @guest99: Tired of your attitude…Read this.
    I can not say anything else. ok? Good luck.

    “It is very hard to say when it will be available as it the European regulations concerning cell therapies are the strictest in the world. We hope to speed up this process as much as possible. There will definitely be progress in the field.”

    Best regards.

      1. @Guest99:The companies are working very hard to bring a new treatment for MPB soon. You will see it. Nothing more to say.

  3. Have to admit, with the new administration Trump’s going to be ushering in, it wouldn’t surprise me a bit if his cabinet repealed anything to do with medical science/stem cells…

    1. Don’t be silly Dan, Trump says over and over he wants the best innovation to happen here, the next big medical cures, bigger space expedition or creating amazing things. He isn’t going to put a halt to things that help people. Hillary however…well.

    2. Trump said it himself on one of his rallies for America that america can become rich either by exploring the universe (hint at Musk probably) or by introducing new innovative treatments. Plus Peter Thiel is on the board and he has a supply of people that will serve in the government to improve the regulation. Plus they’re not using stem cells from embryos much these days.

  4. Another year has passed, only 3 years left to 2020, will we see any breakthroughs in hairless industry?
    Hairloss does affect life quality segnificently, but often people to impressed to talk about it. People have a lot stigma on any solution but hair, such as you can’t wear hat in an office, wearing hair piece has to be very discreet. Pretty much you can’t cover it up if you are suffering from hairloss.
    There are many treatments for hairloss, but none of them is effective enough. So far, hairloss is not curable, like aging.

    1. We are cracking down on both though I believe. We find a way to edit more somatic cells to express telomerase and Benjamin Button will just be a normal love story.

  5. hairclone will make baldness a thing of the past in 2017 . i believe their statemants and i like their team. happy new year guys !!!

  6. HairClone aims to begin follicle banking for patients in the UK in 1st half 2017 and transplanting cellular treatments in 2nd half 2017

      1. Yoda says invalid things all the time. Last year said he had Thorn medical pictures of before and after. Which I know now months later after speaking with them is complete and utter bs

          1. Hairclone.me FAQ says end 2017 they should be ready by 3 to 5 years after that would mean market on year 6 = 2023 2024. I’ll be 37 lmao

  7. Nice blog Admin…

    I wants to ask if anybody can answer, too many subjects tooks part in clinical trials, after trial complition any body does not reports anywhere (facebook, twitter, etc) that he/she got his/her hair back. Where they all are goes??

    Is there any patient who reports on social media or website that he/she participated in trial and regrow their hair??

  8. @Admin Another good post in a time when there hasn’t been much new hairloss information. It’s encouraging to see positive results from stem cell therapies for hair growth. Although it’s not the same process at all, this gives me more hope about treatments like Shiseido.

    Also, Fidia will release their first public statement about their hairloss treatment by the end of this week. It was rumoured by a reliable source that their trials ended yesterday. It’s unclear how significant the news will be, but at this point any news is good news.

    Happy Holidays all.

  9. http://newsroom.cumc.columbia.edu/blog/2013/10/21/hair-regeneration-method-is-first-to-induce-new-human-hair-growth/

    Admin, anyway we can look into this more and follow up on it? Seems like Dr. Christiano has been working on her own hair cloning method. It sure sounds very similar to what Tsukuba is doing. This article is from 2013 so perhaps maybe they are a little further along in their studies by now. Would be nice if we had our own Tsuji cloning method being developed in the US and not worry about having to go to Japan.

  10. How can y’all say that there hasn’t been any major breakthroughs? How about in July when it came out that Dr. Tsuji and RIKEN would have a cure commercialized by 2020? Stop being pessimistic cynics who haven’t even done the research trying to bring the rest of us down with you. Have a little hope in your life. Jesus Christ.

  11. Saw Tony Bennett in the papers today, the man is 90 and look how much hair he has! If he hasn’t had any work done on his scalp I need to know all the details of diet and life style choices his ancestors made that gave him this great gene!

    1. bw a very small percentage of men never go bald nor even lose a single hair, they’ve got luscious hair forever… and that is why I believe hairloss isn’t related with aging… BECAUSE EVERYBODY AGE NOBODY ESCAPES AGING!!

      1. I know genes can be turned on and off. We yet to have the technology to do this but scientists seem to agree many life style choices we make on the daily can do this.
        I wonder if there’s a study that did an in depth examination of all men who never lose hair. They would have something in common other than having a lucky DNA.

        1. Lol, here we go again with bs about bald men having a choice, “you did this and that, its your own fault, you could have avoided it”. Will this myth forever spit in our faces? You cant fight genes with diet and lifestyle, period.

      2. I’m sure some is later in life skin isn’t able to repair itself like it used to but pattern baldness definately doesn’t care what age you are.

  12. Admin

    Can you please do a review of anti sebum shampoos in a post.

    I really think sebum has a major role in our problem.

    There was a study few years ago that showed anti sebum shampoo (Keto + Piroctone Olamine) was beneficial for hair roots.

  13. Follicum reports on their status in their Christmas greetings http://follicum.se/julhalsning-fran-follicum/
    Key points:
    – trials of FOL-005 progressed as planned. Results will be reported in Q1 2017 with a followup in Q2 2017 to confirm the safety after the treatment is discontinued for 3 months.
    – Prototype cream/gel formulation should be finalized in 2017.

    Let us hope they report good results by end of January!

  14. That stemcell 1 year treatment has the same hairline before and after, i dare say its not only (if at all) MPB thay guy suffers from, could be a hypothyroid patient and god knows what meds he been taking in that that year, maybe both dutasteride and synthrol. Optimism is good but in this case with caution, it could be unrelated to MPB.

    1. The stem cell treatment guy is definitely not thinning from a thyroid issue. I have hyperthyroidism and am losing hair from it and mpb. It runs in my family, grandfather, aunt, mem, and my mother have hypo or hyper. My derm and trichologist both confirmed hairloss from thyroid, but said thyroid issues typically thin all over the head, but mostly on the sides and nape of neck. Those are the telltale signs of a thyroid problem. I can confirm since my sides and nape are even worse than on top of my head right now. This guys just looks like he has diffuse alopecia, which is great news if the treatment worked that well on him.

      1. The hairloss is different in hyper, and characterized by thin hair strands, often brittle. Hypo often has general thinning and it thins more in the area with dht sensitive follicles in patients with mpb who havent yet reached their age of onset. Anyway hypothyroid was used by me only as an example, the point is that the guy in the photo is not our typical mpb sufferer, as usual the industry is looking for special cases that yield a great result, like HT clinics who find a part latino guy with high hairline and zero mpb with no receding hairline, give him a free ht to lower his hairline and use him in marketing to fool real mpb sufferers that ht is a miracle cure.
        The guy is the photo is not representative, for sure.

  15. Cool news about Follicum but they are years away from putting anything out on the market. I’m sure it will be a Rogaine on steroids which is fine by me :) That adipose picture has me very excited but also skeptical. If it truly has this potential then why are they not moving full speed ahead and bringing this market. I think this patient had other underlying issues as well like thyroid or TE. Doctors are performing this technique in Europe kerastem and nobody has mentioned results like this. Plus it’s 8k for the procedure which is robbery. That hair clone company I’m my opinion is a HUGE scam! I only believe tsuji will be able to bring this to market. His team is much more advanced.
    If we can get SM and Follica by 2018 then I think many of us will be almost cured or at least have enough hair to not look like we are balding. As for Sisheido, I am clueless. I don’t know what they will achieve and what they are aiming for. I keep hearing different things from maintenance to full regrowth. My question is how can they inject cells into the scalp to protect each follicle? Do cells spread around the scalp easily and attach to follicles? Or is this going to cause a bunch of tumors on your heads?

      1. Hairclone has Claire Higgins though man, I doubt it’s a scam really…. tsuji def will win the race though. What’s ur take on Sam I think it’ll be as ineffective as Kelo and brotzu. Shiseido results will be out in summer this year if not fall.. wonder if we will see any front running in their stocks price…

  16. Hairclone says 3 to 5 years after 2017.
    Correction Replicel says shiseido won’t have data until the END of 2018…
    Follica got pushed back?

    What else is delayed?

    1. Mjones I think ur right about Follica if they can really grow 100 hairs per square cm that’s twice as much as Google search images 100 grafts

  17. Yeah I know Claire Higgins is there but why would they ask for hair donors from now before even having a release date? It reminds me of that hair clone company based out of Oregon in 2002. Not sure if you remember admin…but they claimed to have a hair clone cure and were asking people to store their hair strands for like thousand bucks till they release theit product lol. They went out of business within a year. Hair clone reminds me of that. I just have a bad feeling about them.

    SM will be much more effective than kelopesia and brontzu. Personally I think kelo and brontzu is no better than any other over the counter snake oil. I think forum members at the other website are all smoking crack and our hyping it up like crazy. SM is going through fda trials and have been presenting their results at major dermatological conferences. I’m pretty confident it will be better than Rogaine. It at least is proven to halt hair loss so that’s a plus :) Follica will be available before 2020. They have a prototype already made, app, expansion of distribution of its treatmenta planned at HT doctor offices and dermatologist offices, it’s backed by Pure Tech and universitu of PA. Delays happen my friend but I’m very confident he will release it within a couple years. If not then we better get used to fue, big 3 and or shaving it all off because it will be a while before anything else comes within our reach. Tsuji will solve the puzzle but I doubt it will be commercially available for common people like us for at least 10 years. I sure as hell won’t want to be the first guinea pig to trt it out in 2021. Just like laser eye therapy. It took a while for it to be available after it was passed through trials and perfected enough for people to zap their eyes with lasers lol.

  18. MrJones please, you speak like if you were a very reputable scientist, we all know nothing about the companies but the info they give us, so everything else is conjecture.
    you can not say ‘ personally i think…this or that ‘ about a product cause first, you dont know how it works and second, you can not compare it with other products that still are not on the market and nobody know about the efficacy…

    we have to wait and be patient, it’s okey that we all visit the hair webs but one thing is coming to see if there is something new or interesting and other is coming here to spread pessimist info about things that we’re not able to speak cause we know almost nothing… and then people are going to other webs spreading false info that they saw it on comments like that.

  19. I don’t know why people keep crapping on brotzu lotion. Y’all obviously know nothing about it. There are over 280 pages worth of people raving about it on hairloss talk, and links to an interview with brotzu where he gives some promising info. The science behind it is sound, the only photos available right now show promising regrowth of females with mpb and aa patients. Worst case scenario it is supposed to at least halt hairloss from progressing, and it was picked up by a legit company, fidia. You people throw around the term “snake oil” for anything you think wont work. Snake oils are from illegitimate companies that come up with fancy products that make big claims with no scientific data or trials done. Not a lotion produced by a highly regarded scientist, picked up by a major pharmaceutical company, promising trials, and science that actually makes sense backing it. Not saying its a cure or that it will even work at all, but based on the info available now it looks promising to at least help and be better than current treatments available.

      1. Yes I have been following the 280 page thread and read the interview with brotzu. To me it seems like it would at least be as good as finasteride without side effects. Which could help alot of people, including myself. They are supposed to release a statement about their trials before the holidays.

        1. I remember laughing after they released their before after photos, they were soooooooooooooo grainy and low quality someone commented here and was like. “For God sake wtf is this u think they would have better pictures in the day and age off cell phone cameras” my $100 cell takes wayyy better pics than anything I’ve seen from any hairloss company

          1. No fidia hasnt told me anything personally. But the interview with brotzu gave me some hope that it would work. I know people think that because it will be classified as a cosmetic that it won’t work, but if you read his interview then everyone would have a better understanding of WHY it can be sold as cosmetic. It worried me at first as well, but what he said in his interview made sense to me and I started to hope for it more.
            I do agree the hairlosstalk thread has gotten out of hand and is a joke, but it doesnt stop me from hoping it works.

            1. Well I hope it works out. I personally need regrowth and/or new hair so I’m not too excited about anything in the near future as they won’t work me mine was too aggressive.

        2. “have been following the 280 page thread and read the interview with brotzu”.

          Interview with the maker of a cosmetic product and a bunch of internet hairlossers eyeing a new hope, thats great scientific proof, we are sooo relieved now… geee man, seriously???

          You say crapping, but i see the crap coming from you and not mjones.

  20. Not to start an argument here but Brotzu will be sold as a cosmetic over the counter product like Neutrogena face wash lol. That right there tells me it’s going to work no better than Neogenic or best case Rogaine.

    1. Its a complete hokum. Im surprised it gotten so much attention based on nothing that is linkable to mpb/aga. The doctor even moved it into nomansland by saying it work best in early stages of hairloss, ie people with lots of hair (relatively) where gain is a highly subjective matter and placebo effects rule the stage, “i wash in goat pee and it feels so much thicker”. I went through the same with minoxidil at the early stages, back then i would swear on my life it had some effect, now i can swear even more that it had absolutely no effect on hair. If i been out in the wilderness all day or days and gotten sweaty oily hair, of course it feels much thicker and pleasant if i wash it, even if only with handsoap and cold water in a creek, thats still not a sign of fighting mpb. Dutasteride otoh, now that works wonders on me, its the only real thing out there.

    1. It’s sad sweet gross and beautiful …all irrelevant to us and our struggle which is not as bad as being a burn victim. I wouldn’t take hair from a cadaver that’s just outrageous

  21. Sam got 10% regrowth….. i heard 10% is barely noticeable.

    I hope admin would ask Hairclone whether the cures act will ameliorate the speed to market.

    1. 10% isn’t that great but if it can thicken miniaturized hairs like those short wispy ones we all have that won’t grow too long, thicken existing hair, plus 10% new growth follicles and stop further loss.. then that is better than anything else we have right now.

    2. 10% regrowth is a joke, yep. If a guy lost 50% of his hair a 10% regrowth will put him at 55%. In other words no change.

  22. Don’t forget the Law of accelerating returns, guys.

    Don’t think the medical research in linear terms, it’s exponential. The progress is being constantly accumulated, so every little advance increases the chances of a better solution for everyone.

    Abandon that “It’s always the same since xxxx” mentality. There are rational and scientific reasons to be optimistic, embrace them.

  23. Guest99 thanks for name calling insult. Did you even read what I wrote. I said brotzu at best might work as well as Rogaine. I know Rogaine is over the counter because I use it. We all see how well Rogaine works for most of us. If you are lucky it will thicken existing hair and give you peach fuzz regrowth. The 5% lucky ones get awesome regrowth but that is very rare. Anything sold over the counter is crap. Plus Rogaine was once a prescription medicine and went through fda trials. The only people talking about it is us on hair loss forums. SM, Sisheido, Follica, Tsuji, Bim have all been discussed in real important dermatological conferences, mainline news broadcasts etc. If brontzu actually works to give better results than Rogaine..I’m talking about full Norwood regrowth like nw5 to nw2 like they claim in that hair loss talk forum thread and that 5 yr regrowth crap I will personally buy you a 3 month supply of the lotion. Lol

    Everyone else the future is bright for new treatments..I have a hood feeling for the next 2 to 3 years :)

    1. mjones I removed several of his unacceptable comments and will add him to the moderation queue if it continues, so that his comments are not automatically approved as they are at present.

    2. Mjones, i rrspect you as a poster here, but please, instead of crapping on the lotion for no other reason than because it does not need a prescription, please educate yourself on the actual mechanisms behind the already FDA approved components of the drug.

      There are multiple studies supporting Equol’s impressive DHT binding and inhibiting mechanism.

      There are multiple studies supporting DGLA’s effectiveness as a vasodilator and it’s ability to restore blood flow and vasodilation function to miniaturizing follicles as well as acting as an antinformatory.

      There are multiple studies suggesting the minimization of fatty tissues in the scalp is a contributor to hairloss, and studies show that L-Carnitine helps the scalp metabolize and promote fat in tissues.

      There are multiple studies about Liposomal delivery significantly enhancing the effects of topical lotions.

      Mjones, I have no problem with skepticism, but saying the lotions best case scenario is Rogaine like results only because it is classified as a cosmetic is unfounded. It could have been classified as a drug if Fidia would have stuck with PGE1 instead of opting for its precursor DGLA. The ONLY difference between a cosmetic Fidia lotion and a drug Fidia lotion is the switching of two compounds that do basically the same thing at the same level of effectiveness. Are you suggesting that the lotion would have so much more credibility if this one tiny alteration wasn’t made?

      If there are reasons to be negative about the lotion, IMO it being classified as a cosmetic should not be one of them because it is completely insignificant as it’s components have already been proven to work effectively. It’s not like the hundreds of cosmetic scams out there that have bullshit amino acids, sugars, and proteins and claim regrowth. These compounds are actually based in solid science.

      The fact that all argument’s to the lotion’s contrary are based on irrelevant things like cosmetic classification and grainy printer scanned before and after images rather than in its mechanisms and science is encouraging, at least to me. I’m not saying the lotion will work for sure, but the lotion is based in good science and has good potential to be an upgrade on Minoxidil and Finasteride.

      1. Thanks Admin:)

        Red- You make some solid points and I agree about the equol and it’s dht blocking abilities. Now I just thought of this that maybe in Europe this may fly as non prescription and over the counter. However if it’s as powerful as you say it is in blocking dht then I have a very strong feeling that this will be forced by the fda to go through safety trials and be prescription based like propecia.

        1. This is possible, yes. It could require a prescription in the USA, it depends on how the FDA classifies the mixture and whether the lotion has any side effects. I’ve done some digging on this, and don’t think it would require a prescription in the US, but there’s a chance it could.

          I’m honestly just hoping it works. Being able to walk into a store or order it online in privacy and just buy it on the spot without needing a prescription would just be a bonus.

  24. off topic:
    riken /tsuji team: ” based on the results we have, it is said that in case of a human being, there are about 60 to 120 hairs growing in an area of 1cm2… and we can easily control that with our technologies.”
    “we think that we may be increase follicles at least by about 100/1,000 times”
    with 150 follicles * 1000 you will have 150000 and a full head of hair
    worst case : with 1500 (a really poor area) * 100 you will have 150000 too :)
    patience… only 36 months…

    1. Follica is superb! If the company was in Japan we would have the treatment by now. Thanks for the link hopeful, and we’re still hopeful : )

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