Histogen HST-001 Hair Stimulating Complex Folds

So Histogen was likely the biggest joke in the history of anticipated hair loss treatments. Worse than Aderans and Intercytex. Worse than Aclaris. They fooled us twice over the course of 14 years since inception. Most companies (e.g., Kythera) fold their hair loss program or their entire operations much sooner.

Histogen Ends its HST 001 Program

In recent years, I essentially gave up on Histogen, but still wrote the further below clinical trial update post in February.

Now, per today’s news, we know that HST-001 is over once and for all.

“We will suspend development of this (HST-001) program. We believe the best business decision at this time is to redirect these resources towards our high value orthopedic programs.”

The only positive is that most readers did not have high hopes of Histogen’s hair loss treatment being that effective. So this is not a big disappointment, even if we did not expect such a sudden cessation.

I do wish I could get back the time I spent in writing over ten posts on the company since this blog began :-(

HST 001 Clinical Trial Update

Feb 16, 2021

Histogen HST 001
Histogen Hair Stimulating Complex (HST 001) trial schedule.

In 2012, Histogen announced 24-week results from their Phase I/II clinical trial of their hair stimulating complex (HSC). This product is also known as HST-001 and used to treat male pattern hair loss.

In 2021, Histogen just announced 26-week results from their Phase 1b/2a clinical trial of HST-001.

HSTO for the Back to the Future win!

Mockery aside, CEO Richard Pascoe said that a larger clinical trial will commence in the second half of 2021.

It seems like the hair stimulating complex works well in growing some hair in men with androgenetic alopecia. However, just as with the week 18 results, the placebo group also witnessed similar increases in hair count. There were no significant issues with safety or side effects.

I cannot be bothered to find out if some in the placebo group were using any kind of hair loss treatments such as Minoxidil. Most likely, that would not be allowed.

Per Histogen’s website, the HSC contains growth factors including KGF, VEGF, and follistatin.

92 thoughts on “Histogen HST-001 Hair Stimulating Complex Folds”

  1. It doesn‘t sound promising, to be honest.

    I mean, „no statistical significance compared to placebo“ is a killer line.

    But why there is „significant efficacy“ overall is a mystery to me.

    Must be one hell of a placebo!

    1. Abysmal and just purely shameful at this point. The researchers at histogen are now entering career researcher status.

      The truly groundbreaking treatments that I’m focused on are (and I mean that relative to what we have now):

      1. Follica
      2. RCH DP injections
      3. Kintors pipeline

      Follica with RCH and ky or kintors SARDS can be a good bet for early stage balding. The truth is, I don’t see any current hope for advance stages of alopecia besides cloning. I do think most of the good pharmaceuticals will be coming out of China. I hope india gets into the game because they have had success in treating many diseases before

    2. I agree and we know now that “humans” can make a flu vaccine in 9 months (make it 3 or 4 vaccines actually) … Serious researchers just don’t care about hair or skin. Our only hope is serendipity, a happy accident, like Minox or Fin. ;-)

  2. I imagine in the second half of 2031or will it be 2041 that they’ll release some more p*ss-poor results? I understand things take time, but this is getting ridiculous. What on earth do these Histo lab-coats do all day? Should be called Fund Stimulating Complex.

      1. the real concern is who are the investors of this treatment…the poor lads.

        These are the reasons why there is the decay of trust in alopecia biotech initiatives, as admin mentioned in a previous post. Histogen needs to wrap things up and let others use that capital

  3. What a joke. I think that the first time that I read about Histogen was more than ten years ago, and still they are on phase 1b and 2a , lol .

    1. they actually had good results before. wtf is going on with this company. they should just donate whatever money they have to tsuji and exit stage right

  4. http://en.huapont.cn/product/74.html

    HISTOGEN PARTNERED WITH HUAPONT CHINA WHICH MAKES DUTASTRIDE

    DUTASTERIDE

    Dutasteride 164656-23-9
    Therapeutic class:
    treatment of symptomatic BPH
    Chemical Formula:
    C27H30F6N2O2
    Molecular Weight:
    528.53
    CAS No.:
    164656-23-9
    Synonyms:
    AVODART®
    Regulatory:
    Written Confirmation is available upon request/DMF open part: available upon request
    Specification:
    In-house
    MSDS:
    available upon request

    1. Thanks admin for the positive news on RCH-01 after histogen was a complete failure. But the thing is that RCH-01 only produces a 10% increase in hair density which is nothing and the affects only last for 9 months and one has to fly to Japan. There truly isn’t a hair loss cure truly .microneedling will still be the best option for another 10 years. There’s a reason why elon musk is not investing in generative medicines with his smart mind he probably saw that it’s far and away from reality. I hope he does cloning experiments on Mars cus it seems like no other country wants to touch cloning. In my humble opinion

    1. Thanks. Went to spam first, but I happened to check that folder today. Rassman told me in January that he would give me an update on this later this year. May bug him in March.

    1. Samumed had clinical evidence, even for terminal follicle count. They are not a “miracle cure”, but… It’s realistic and better than Minoxidil.

      Follica + SM04554 will be interesting, I think…

  5. I can’t wait for the SAMUMED update soon. I’m hoping to get some of that or some Wenlevi/Breezula (or both) on the grey market and be a guinea pig. It seems like things are happening.

  6. Admin riken made another update on there Facebook page today regarding Dr tsuji hair cloning, just thought you might, find it interesting.

      1. You do good work admin, may I ask you for your educated opinion on a potential release date for Dr tsuji hair cloning ? Thanks for your work

  7. Hairlosscure2020, here’s the cure for baldness- let’s decode it!

    BAY-1158061 is the hair loss drug which makes Finasteride and Minoxidil look like onion juice. Seriously.

    After six months of treatment, the number of hairs in the hair loss area nearly DOUBLED, even in areas that had previously been nearly COMPLETELY BALD, and the effect continued for more than four (4 !) years AFTER the drug was discontinued. And these numbers were thick terminal hair increase, not vellus. The drug also literally worked better the balder the area was.

    This study was not done in mice, but in macaque monkeys. This is the gold standard as these monkeys actually have male pattern baldness characteristics. In laymans words, this is a huge deal. And as this wasn’t amazing enough, you also only need 1 injection every 14 days and you are done.

    Chances are you haven’t even heard about this drug at all. However it is currently being worked on behind the scenes at one of the biggest pharma companies in the world Bayer AG. As of now it has passed phase 1 clinical trials (focus on safety).

    BAY-1158061 is a prolactin receptor silencer. It consists of many amino acids set together to form a polypeptide antibody for the prolactin receptor.

    Bayer does not want us to find out the whole sequence to this antibody, and thus getting the treatment already through grey market channels.

    so….WHAT DO WE NEED TO DO?

    Hairlosscure2020 work your magic. Let’s decode the patent, or send it to your scientifically gifted friend (it will help tremendously). We think we have the sequence but we need the N and C terminus/terminals.

    All info you need to crack the code is here:

    https://patentimages.storage.googleapis.com/a2/fb/31/23bcc752e93829/WO2019011719A1.pdf

    https://patentscope.wipo.int/search/docs2/pct/WO2014036076/pdf/75c_IIgrSeDbTWrJkER6AspOntyvGYWMGtwaHxpaO55gKab6gel3Dl722vE3ha8lSW4L0M33CEr9RskMuU7_YZHoznDBR7gXV1KBxfEFnt7Kg3Fni9RQ07F0rIxR_6Ri?docId=id00000024176613

          1. Hi there are a few comment replies in the thread that will also disappear due to the order in which they were made. Your comment has nothing controversial in it, so I will leave as is. And your real name is not there anyway.

  8. One slight but important correction to your post is that in the 18 week update they stated that placebo lost hair while (although not statistically significant from baseline) the group treated with HST showed growth of new terminal and vellus hairs

    This inconsistency is very confusing and is very poor reporting on histogen part either deliberate or incompetent either are a bad sign – best thing they can do is actually publish the detail study results and let people see the data

      1. I agree very confusing- this is the worst worded press release I have read in a long time – to make matters worse the whole reference to “statistical significance vs placebo” is excluded from their investor presentation which was updated 17th Feb – if it is such a key point should be in there for sure!

        I have written to the company pointing out these inconsistencies and asking for some clarification – If they bother to reply then will let you all know what they say.

  9. This sounds extremely interesting…………thanks Tom and Admin. Despite the fact that I try to read all posts and comments, I don’t recall the original prolactin receptor post of April 2019. Can’t wait to hear more. I did a quick search and found the study below using BAY-1158061 in postmenopausal women which indicates a very strong safety profile. I don’t see anything new but if safety was confirmed 2 years ago, I can’t believe there hasn’t been some good progress since.
    https://www.researchgate.net/publication/325401324_Monoclonal_Antibody_Against_Prolactin_Receptor_A_Randomized_Placebo-Controlled_Study_Evaluating_Safety_Tolerability_and_Pharmacokinetics_of_Repeated_Subcutaneous_Administrations_in_Postmenopausal_Wome

  10. Admin a YouTuber goes by the channel name hairliciously posted a video earlier today he has a email interview with Dr tsuji in the coming days.

    1. Woofy you beat me to it but I was going to mention it. But yeah admin the youtuber hairliciously was granted a opportunity for a email interview. And hes asking the public to send him questions to ask Dr tsuji, and I think you admin with all your knowledge can work well with hairliciously to formulate a good questionnaire for Dr tsuji we basically just want to know when are human trials going to start and commercialization of the procedure. In your name Lord Jesus Christ please let hair cloning be able to happen.

  11. Admin totally agree about our endocrine systems. The last 20 years are food supply has been gmo, altered, new chemicals, pesticides, 3d printed meats, plastic causing alterations with our hormones etc. That’s just the food part. Then you got pollution, chemicals we breathe in from various places. It’s crazy. This causing havoc on our bodies daily. Imagine what its doing to our hair. I don’t see this ever getting better for our society and just worse. Only thing we can do is try to eat organic, grass fed meats and stay away from chemicals.

  12. So Dr Rassman hairy nevus treatment would fall under FDA biologics? So does anyone know what the biologic approvel process is like? And why does exosomes not go though that but his treatment does?

  13. This kind of thing is what makes me skeptical of them all. I get some things fail, but they weren’t very transparent. Not a big surprise, but still. Another player down/out.

  14. Didn’t they Change the formula? If so, they should have continued with the original formula. Those results were actually impressive. Oh well. Replace Histogen with Dr. Rassman’s hairy nevus treatment, that has way more potential. But don’t hold your breath and don’t pay close attention to these injection treatments.

      1. Marc they don’t work very good. That’s been shown multiple times. The only real cure is to create the follicles and then transplant or crispr. The injectables will look great in science fiction on AGA but it’s not looking great in the real world. The only things I see that have real potential is stemson, tsuji, UC Irvine hairy nevus topical (because what a hairy nevus can do to a human) and verteporfin for the donor area.

        1. @woofy thanks for the reply. So you still believe in Dr tsuji huh thats cute. Cus i truly believe Dr tsuji is done and with Stemsons therapeutics i like them but lets be honest here and stop putting so much hope in these companies other people are saying release date is 2027 pffff please thats like a 2% chance of happening more like 2033. In my humble opinion but i know in right .

  15. Thanks for all of your reporting admin, even if it’s not great news. I do believe better treatments will come in time. In the meantime, I think I need to save my money and stop foolishly paying for organic “serums” that do nothing. The cosmetic industry preys on insecurities (and our wallets) with minor results. I’ll wait for real results before opening my wallet again.

    1. I’m doing the same. My new way of thinking is this: until something new (and real) comes out, I won’t stress about what I can’t control (hair). Instead, I’ll focus on what I can control – my overall health, diet, finances etc. Basically, make myself ready for a cure….physically, mentally and financially. I have zero control over when a cure comes out. But there are other things I do have some control over.

      Easier than said not to stress about it, but I’m working on it.

  16. I predicted this my dermatologist told me that all these companies working on hair cloning Will be bankrupt histogen is done Dr tsuji is almost done tissuse is à joke. Our only hope. Is microneedling and minoxodil!

  17. No they weren’t Woofy97.
    I explained this years ago. You have to be consistent. You can’t complain about things like PRP/ACELL/Amniotic fluid/exosomes etc and then be excited about Histogen. Their results were never even as impressive as the Acell+PRP results from a decade ago.
    Histogen “worked” but certainly not any better than any other mediocre growth factor injection. Way, way, way too weak to care about.
    And their photos were a farce and completely disingenuous.
    Naughton was determined to to drag things out as long as possible and keep the money coming in. It was obvious by 2012 that they had no intention of being honest.

  18. Uk Hairclone will be the next one to go bust ! Followed by follicum and Dr tsuji. Truly the only company I have hope for stemson therapeutic. A real hair loss cure is not happening until the next decade.

  19. Tsuji will fail for sure. They do not have a single proof of their result What a joke!! Till now we saw results from Follica that’s all even though it’s not impressive. Do not think about cure it’s not coming.

  20. It’s hard to believe we’re here. A problem impacting this many people worldwide. I get it’s cosmetic, not life or death, but look at what’s being spent on hair loss gimmicks and half solutions (minox) every year? Insane amounts. So much money to be made and we’re making huge advancements science- wise. I can’t believe someone, somewhere, can’t figure this out. It’s that difficult?! It’s got all the scientists beat?

    I’m just venting. I’ll be fine tomorrow. Probably.

  21. Don’t beat yourself up Admin. It’s like when you realise you’ve been dating a narcissist. You couldve wasted a whole lifetime instead of days, months or years. Cut your loses and run. Glad to see the back of old Histo. Sounds like it was nothing but boiled shite to begin with. Be great to have a bs detector for every half-baked, research-fund-grubbing company that comes along. Otherwise it’s just a waste of O2. Either put your product on the market or f off. Next! (Don’t worry kids, there’s so many more disappointments to look forward to. When they go bust, at least you can say, ‘See, I was right’). Onward and upward.

  22. This is good news actually because it means we will never have to suffer reading the word histogen ever again.

  23. Next up to bat: follica. Will they hit a double (doubt HR), or will they strike out like Histogen? I feel like follica is the guy on the injured list where it takes forever to see him play to see what he can do.
    Ps: wouldnt mind a young hot shot scientist who wants to live in the lab for the next 3 years or so, take over for Cots. Cots of course would have to share his research. I think new energy and youth may be needed.

  24. All we got is follica left……..everything else failed and the ones remaining will end up like tsuji or hsto.

    1. mjones all we have left? I’d forget about Follica they have been doing this way before tsuji with a micro needling device that does little difference (you already know). Tsuji didn’t fail he just needs money. Until I see news/evidence saying he failed, then he failed but we have not seen that yet.

  25. A study was done on 35 subjects with AGA using a once daily topical hemp oil formulation, averaging about 3 – 4 mg per day of CBD and minimal amounts of other cannabinoids for six months.

    A hair count of the greatest area of alopecia was carried out before treatment and again after six months. The results revealed that men did slightly better than women, and the vertex area did better than the temporal areas.

    On average there was statistically significant 93.5% increase in
    hair after 6 months. All subjects had some regrowth.

    There were no reported adverse effects.

    https://healthhacker.com.au/category/science/hair/

    1. This article is from May. With over a 90% increase wouldn’t it haven gotten more attention by now? Wouldn’t it have reverberated across continents?

      Seems unlikely. Also, no photos. Call me skeptical. Mr. Skeptical.

      1. I’m optimistic tbh. I think success will likely come from something like this, rather than from scientists in the field who only want grants to continue playing around in the lab.

    2. Great were back to zero again rubbing oils onto our scalps after years of waiting for histogen and Dr tsuji and rch-01. Where is ukhairclone. Arent they supposed to have started offering injectable stem cell treatments starting 3rd quarter of 2021. What a cruel joke the 4 billion dollar hair loss industry is! And by 2023 Dr. tsuji Will have called it quits… Its all a scam ive spoken to many top surgeons in north america and they all told me the same exact thing. Its 20 years away and that was in 2015 and here we are in 2021 and its gotten worse!

        1. @Bearly

          If they don’t have pictures to back it up, I can’t take it seriously. Esp when boasting a 90% increase. They should have plenty of amazing pics. Try it and let us know. I’d love for it to work. I’d take a 10% increase at this point.

          You may be right about something natural but baldness has been around for so long, it’s hard to believe everything natural hasn’t been tried already in every combination. And yeah, it’s clear some of these companies pushing a scientific cure are bogus….but the science is there (for example, we know it’s technically possible to clone hair). It’s doable. We just need all the pieces to come together. If they were doing it out of kindness I’d say it’ll never happen. But it’s a 4 (?) billion dollar a year industry. That’s a lot of money to be made. Plenty of incentive. Grants don’t even come close to what they could potentially make off of a cure.

  26. Well, you may want to buy stock in alcohol companies cause it looks to my future. I refuse to take antidepressants.

  27. Only KY19382,HMI-115 and possibly SMI-6 are the treatments you should keep an eye on. They have the potential to cure us all, and we will know for sure in the next weeks to months.

  28. I’m just going to pull the trigger and meet with a doc about a HT this winter maybe. See what my options are. Not great I’m sure as my donor site is rather thin too but we’ll see. Obviously, sad as it is, there won’t be a breakthrough anytime soon. Look how long we’ve been waiting with zilch to show for it. We could be waiting twenty more years. So depressing.

      1. @Tomjones

        Only thing I take and will continue to take is oral minox. I can’t do fin. I tried it once long ago and didn’t react well. It was eons ago but I’m not willing to try it again.

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