A Histogen Review In 2019
The biotech startup from San Diego has had quite a background story since emerging onto the hair scene back in 2009.
It had occurred to me that Histogen is now officially the longest-running “in development” hair-growth company in the world. And, when you look at that beginning date closely it starts to make sense – 2009. We’re talking about a full decade of a wild rollercoaster ride known as “Histogen HSC.” It’s only right that we retrace the steps of this enigmatic company. Yes, it’s going to be a long read – but an interesting one. Here we go.
The Stuff That Dreams Are Made Of (Credit: San Diego Union-Tribune)
A Timeline For Hair Stimulating Complex (HSC)
To begin, Histogen’s hair stimulating complex was originally called “Regenica”, that’s a name that new comers to the hair growth game will be unfamiliar with. Regenica was announced as an “injectable liquid product made by culturing fibroblast cells from newborn tissue and collecting the growth factors which the cells secrete.” In December 2008 Histogen launched a phase 1 clinical trial in Honduras for Regenica which was bound to change the landscape of the hair restoration industry for good. It looked like the world could be heading towards a new futuristic “stem cell injection” that was going to magically make hair sprout up on scalps everywhere.
However, it would not be long before the Histogen hair train would be initially derailed from its righteous course of action. On January 23, 2009, it was announced that the company Skinmedica of Carlsbad, CA had filed a patent infringement lawsuit against Histogen and its founder Gail Naughton. At the time, Skinmedica alleged that Histogen’s technology was infringing upon two Skinmedica patents which covered its own product line called Nouricel, and its technology based on culturing human cells in a growth media.
You see, Skinmedica had acquired those two patents back in 2003 from a company, Advanced Tissue Sciences, which was previously headed by Histogen founder Gail Naughton. Now that Gail was at Histogen, Skinmedica claimed they owned the rights to work being done there. When this lawsuit was administered Histogen was forced to lay off all 36 of its employees and lost a pending investment deal for $2.4 million which was supposed to be completed the next day with a group of angel investors. This was the beginning of the bumpy road Histogen had to endure while trying to move its hair growth therapy forward – and even stay alive as a company.
First Glimmers Of A Next-Gen Hair Therapy
On February 17, 2009, news was reported in the media that Histogen was presenting positive preliminary results from its first human trial using Regenica to treat male-pattern baldness, before the trial was completed. The trial included 24 male subjects ranging from 18 – 45 years old. Just past mid-way point in the study’s 5 month duration Histogen announced that the treatment showed “increased, thicker hair growth, with no adverse events” among trial subjects. Great news for the human race.
Then again, shortly thereafter, due to the lawsuit filed by Skinmedica, Histogen scrambled to raise funds for its company by focusing on selling cosmetic skin-care products under the brand name Regenica. The company even had about 18 employees working for no pay just to try to help move things forward and hope that it paid off in the long run. Later in the year on July 27, 2009, Histogen presented the completed results of its phase 1 trial involving 24 male subjects with androgenic alopecia at the Annual Meeting of the International Society of Hair Restoration Surgeons. The small image below was published along with the press release.
This image from the press release displays two sets of photos from trial subjects taken under microscopes. At the 3 month mark, the subjects displayed improvements in hair count at 22.4% and 23.7%, respectively. This presentation also marked the inauguration of the name “Hair Stimulating Complex”, replacing the former Regenica moniker.
Clinical Trials Seemed To Progress
Another update would come on January 15, 2010 as Gail Naughton told Xconomy magazine that the company was planning another 50 patient study in Singapore to happen by June 2010. She even eyed plans for a further trial past Singapore which would take place in several Asian countries and involve around 250 patients in spring 2011. And if that trial went well then Naughton expected commercialization approval in Asia for every country except Japan. (Note: Imagine if HSC was approved in 2012?)
It would not be long before another micrograph of scalp images would show up in the media displaying an improvement in hair growth by Histogen’s HSC. On April 14, 2010, Histogen was back in the media to announce the lasting effects of HSC.
After one year post injection HSC was able to maintain a 73.61% increase in hair growth. From baseline, there were 84.5 more hairs in the photo taken a year later. This was another promising facet of this serum which was now becoming more precious to men ages 24 – 60 than gold is. Happy days were there again, too, when Histogen raised $10 million in a Series A venture round on December 1, 2010. The lawsuit was still being fought with Skinmedica, but apparently only applied to Histogen’s Regenica skincare line and did not affect HSC and potential therapeutics for cancer. Investors were now willing to engage with the company again.
It might have seemed to good to be true on May 24, 2011 when U.S. District Court Judge Janis Sammartino addressed a courtroom full of representatives from Histogen and Skinmedica and declared that Histogen’s method using microcarrier beads to grow its fibroblast cells was distinct and different from Skinmedica’s patent. This lead to an official ruling on November 21, 2011 by federal court that Histogen was free and clear of Skinmedica’s patent. Gail Naughton told the media: ““We are happy to now have this matter officially behind us.” Unfortunately, this moment of satisfaction would not last long.
However, in the meantime, more good news piled in. On May 11, 2012 Gail Naughton presented results to the Society for Investigative Dermatology’s Annual Meeting from a HSC phase 1/2 trial which took place in the Phillipines involving 56 patients both men and women. (This was the trial that was originally thought to be planned for Singapore) The presentation declared that at 12 weeks into the trial, patients showed a 46.5% increase in total hair count. (Note: the numbers that HSC has put up in its trials really dwarf the statistical results that have been prevalent across the industry since then) 
Also, at the time of the phase 1/2 trial results, Histogen was engaged in a physician sponsored study of HSC in 10 patients which was headed by Dr. Craig Ziering. This small study by Dr. Ziering led to one of the most iconic Histogen results we have seen to date, the infamous “Histogen guy” photo seen above. (Note: this photo was actually not released until several years later, but it did originate from the Ziering study) Minus the obligatory internet skepticism, this photo was well received by many folks across the interwebs and the hunger for HSC thrived on. Several more human photo results from the same study would be released and the legal battle with Skinmedica would be reawoken. There is truly no other story like Histogen out there, it is in fact so epic that it needs a part 2 to complete. Coming soon.
To be continued….
Posted in Hair Growth Treatment, Hair Loss Cure, Histogen
This is what we are talking about in comments. All this studies is nothing to do with the real market producs. They are studying, trialing, issuing releases – just earni.g their money with it.
Tks Admin! Waiting for good news asap!
does that finally mean that we have a solution coming up soon?
Good read hopefully it end with happily ever after
So what’s the takeaway here? Will part 2 provide updates on what this means for us?
10 years ago we had a solution that increased hair density by 76,61%, which is basically cure, and better then anything we have on trials NOW by a factor of at least 5, what the hell happened?
HSC is a powerful and effective injectable treatment…
Perhaps it’s the fact it was injectable that produced such good results. Only treatment I see doing anything similar in some patients is RT1640.
I agree, but my point was: You have something safe, non invasive, relatively cheap to make, better than anything competition had by a mile, what the hell happened?
I think for certain the whole story will never be out in the media completely. The first lawsuit definitely threw off the company’s plans in a big way, I guess since then they haven’t been able to get back on track 100%. Trials take a lot of money and then it takes money to pay people to run the company. There’s always more to it that we don’t know.
I wonder is Histogen is contemplating a topical HSC product now that dermarolling is so popular.
Thanks for the info! Has there been any update on their Phase 3 trial in Mexico? And do you know if a successful trial in Mexico would allow for treatment only in Mexico? Or other countries as well?
There’s been no update on the phase 3 in Mexico, some people guess it might be cancelled. It’s possible but I don’t believe that at this point.
Successful trial in Mexico would allow for treatment in Mexico only. Hypothetically, they could have a clinic just south of the border below San Diego. It would most likely be a convenient process.
So it seems Skinmedica keeps presenting itself as an obstacle to a cure? It is quite frustrating hearing how close we get to something that works and on the way to market, only to get stopped because of patent rights. The difference between many people suffering from hair loss and being happy is a result of a patent fight. So sad,
Good point. Myself and many others have had the same idea you just had. It is a sad thing how greed really impeded a terrific solution to hair loss, done by executives making huge salaries and living in great locations with nice weather. Strange world.
One cannot help but wonder if these private companies are fraudulently operating under the guise as biotech businesses as a way to capitalize on purported research to garner venture capital and raise hopes that they have a novel drug, system, or device and procedure that can cure, treat, or produce something that may marginally do a better job than what is currently available and being marketed currently. Over a decade of development isn’t to be celebrated but questioned and investigated by the FBI for racketeering.
Hear ya, Steve and definitely not celebrating but rather opening it up for discussion. But the fact that they have been facing litigation for the past ten years points to the fact that this wasn’t just a scheme.
It’s basically unquestionable that Histogen has a remarkable product, the details on why it’s been so slow remain hidden. People in the industry close to their location must know more.
Great article. Can’t wait to read part 2. Histogen is my favorite treatment in development by far. Phase 3 ends summer 2020.
Damn another year just for phase 3… and still no guarantee this will even make it to market. We should all just shave our heads
@JohnathanWeaver Thanks!
Why could they only market in Mexico?
Because there is less regulations. It will take probably 3-5 years to get FDA-cleared in USA/Europe.
This is why whenever I hear of a new hairloss breakthrough and then see it is being developed in the US I throw my hands up in the hair. You’d think that would be the best case scenario, but you just know they are going to have to jump through so many hoops and it will take forever to come to market. I wish more companies would do their development in countries with less regulation to expedite the process.
So Histogen is still really nowhere near launch? Lot of research / trials has been done but they still need to more before the release, correct?
Right now they’re mysterious about a phase 3 in Mexico, it was announced but no updates for a little while.
Still have phase 2+3 in US for men.
Just finished phase 1 in US for women.
Mexico is the best hope for now.
@Follicle Thought Would you say they’re in a better position than Shiseido?
I’d only say they’re in a better position than Shiseido if the reason Shiseido is taking long is because results are not showing up, and the phase 3 trial is still underway in Mexico.
Is there any way they could be contacted and asked about this phase 3 trial in Mexico?
There doesnt seem to any info on it.
Also,
Their product pipeline shows HSC660 for Male Alopecia currently being in phase 2?
Great article. I am looking forward to Part 2.
I personally believe they scrapped phase 3 Mexico and starting a phase 2 for their new more potent hsc formula in the usa. Makes sense I know I wouldn’t go to Mexico to get injections on my scalp or trust their version of fda regulations. Not trying to insult Mexico but it’s definitely known for corruption and lack of safety. Either way I think hsc is just an investment scheme to fund their company. 10 years and now they are back to at least another 5 years for potential market release. I was very excited about histigen back in 2013. Thought I could regain my lost density and stabilize. I should have known better. All these companies are either scams or they just hype of treatments that don’t work any better than the big three. Only one that has some sort of potential is follica but even that is becoming sketchy. I’ve in this hair loss game for 20 years and it’s always the same story. I wouldn’t be shocked if the makers of Rogaine and Propecia are blocking better treatments…..
Interesting theory. Though, I do still think a lot of people would be willing go to Mexico for the original HSC.
What about Follica do you find promising?
Who here would go to Mexico for original HSC if it was available next month? Why/why not?
Well, there is a problem. If I understand the procedure, you would need multiple injections every 2-3 weeks for 2 months. This would require either to stay 2 months at Mexico or come back every 2 weeks. For an american it would be feasible, but for europeans…..
I would fly there after I have trialled NGF-574H (or the competitor from California) WITH dermarolling. But I would rather fly to China (Huapoint). Same distance for me (Austria) plus China is a safe country whereas Mexico is not!
I think admin have something up his sleeve
Truthfully, I’m just trying to stimulate conversation about this topic, I think people are interested in it.
I feel HSC has value, it would have great value in Mexico still, even the original HSC. For now it’s unclear how much better HSC660 actually is. I wonder what the possibility of HSC660 coming out as a topical and used with dermarolling, just like the skin creams that are commonly sold across the world?
I dont think NGF will do anything wer stuck with this cancer
Who is the competitor from California?
Is that the one admin mentioned with no name?
Hi admin, I like how follica was mentioned on the NBC nightly news back in 2009. I know it was a decade ago but it was the only treatment from all the ones we talked about the past 10 years to be mentioned. I like how it potential is to create new folliclea 30 to 100cm2 new regrowth and that it can thicken up dying weak miniatureized hairs. Could be the real deal for us low to mid Norwood and diffuse thinner. As for Mexico I wouldn’t even go there for vacation let alone have some random doctor inject hsc into my head. Ideal situation is to go to your family dermatologist and get it done. Of problems happen you have a reputable doctor to go to and it will be fda regulated.
I wonder where the idea that Follica could create 30-100cm2 new follicles came about? I’d love to see it but never heard that about the company.
Yes admin, it was listed in puretech press release about a year ago or so. They claimed 30 cm2 hairs terminal and 100cm2 neogenic hairs from their treatments. New follicles. Impressive results if they can actually do this. I don’t trust any hair loss company anymore tbh…
Just reviewed recent Follica stuff to see where this idea might have been coming from. My guess is from this image from Puretech media kit. If that’s not it I’d love to see it because I really don’t remember Follica saying this.
If this is the case, that’s an exploratory new drug and preclinical result on a mouse, never been applied to any of Follica’s trials so far. Beneficial to the industry as a whole, but not a forecast of 30cm2 in human scalp.
Would go to Mexico in a heartbeat. Injection therapies seem like the best way to go because it does not require everyday application. Really hoping that this or Replicel is available soon
I think that follica is the only one that can produce results like 30 to 100 hairs cm2. The durhat study showed that dermarolling and minox alone produce robust hair growth more than anything we have seen with current and future treatments. Tkose were not mouse preclinical studies. It was done on human scalps. If follica is producing a derma wounding technique and a cocktail compound then they should be able to produce similar or better results. Durhat is one of their researchers. Dermarolling alone sure beats rivertown 4 single hairs lol or jaks regrowth results. All I know is that it’s 2019 and we should have had at least 2 new fda approved hair loss drugs by now that significantly outperform the big three. There was more success between 1985 to 1997 then 1998 to 2019 in terms of releasing new drugs. Its very fishy and shady that all new mpb research companies fail.
I appreciate your contributions here and I’m getting more excited for Follica lol.
Truthfully though I root for them all because the more weapons the better. But from an objective observation, I don’t understand the RT 4 hair comment because literally never seen a treatment that can do this for a bald 60 yr old regeneration on a dormant scalp it’s not a full recovery by any means but its hundreds of regenerated hairs. Wish more people would jump in the convo here.
I am surprised nobody talked about Samumed. Their phase 3 ends in june 2020, like Histogen. Samumed is topical treatment, which binds to DHT so that the DHT cannot bind into the follicle site. Basically it’s like a finasteride but without losing your DHT and thus no side-effects. Could be in the market late 2020.
Without being overly optimistic, can we recap a bit and consider time horizon until end of 2020.
1. Histogen: HSC trial has been aborted as we have zero info from Histogen in its updates. Actually the whole info came from San Diego newspaper only. I have seen nothing on Histogens website ever. But I may have overlooked it.
2. Celino: NGF-574H might be a replacement for minoxidil. Beneficial for people who are non-responders to minox. However I somehow get a bad feeling about it tbh.
3. Sisheido: We dont know efficacy. If they release and if its available for foreigners once they release.
3. A still yet to be disclosed topical similar to NGF-574H. We have no info about efficacy etc.. Perhaps admin has details but cant release them yet.
4. Follica: Probably towards the end of next year if we are lucky. Efficacy is still unknown.
I believe its not beneficial to many if we are too hopeful. What may happen is that people in the hope of better treatments soon may not use established treatments due to fear of sides etc.
But if you wait in vain you lose more and more hair. I have BPH and thus use Avodart. Thus I naturally dont worry about sides as I have no options.
Better be realistic than hopeful at times.
Thanks for summarizing the most hopeful near term companies MRKA. It is unfortunate that even those are probably 3 years away at best, given there seems to be an onslaught of delays and obstacles and for a product with uncertain effectiveness. I feel jaded and beaten down from reading about how many companies get sidetracked and I really hope there is a company on the right path that is operating in stealth mode and will reveal themselves once a solution is ready for market, High hopes I know. Sadly the options available now don’t really even seem like options given the minimal effectiveness and uncertain side effects,
Good point. Some people and women generally don’t have much use for current options. The best we can do is keep the search on for the next best potential treatment and see how it shapes up. I keep hope for a company emerging with a really effective treatment as well.
To MRKA’s point, it is also practical to make use of current medicines when possible for a person. Though, of course, a lot of people are hesitant about fin with or without betting on a future treatment. It’s a tricky game to play but one thing everyone agrees on is we deserve newer better treatments.
Hi Admin,
Are we still expecting you to publish the article revealing ‘something big’ that you’ve referenced in a few articles recently?
Thanks,
Yes, it’s related to the sector of hair multiplication. Will follow up on it as soon as the company gets back to me.
I honestly just wonder what a realistic timeline for turning a Norwood 7 to a 1? At 29 years young I look terrible. 10years?
Technically possible by 2025. Replicel will take a few of your follicle, replicate it a thousand times and then transplant them in your scalp. But the ultimate cure will be through CRISPR, to make follicles invisible to DHT, ect….
I don’t think Replicel are planning on doing haircloning.
Thats Tsuji.
I’d agree that Replicel does not seem like a treatment that can do NW7 – 1. It seemed more like a filler-in type of treatment. Maybe turn a NW4 back to a 2, or turn a NW5 + big hair transplant back to a 1.5. Something like that..
Jonathan Weaver, I don’t think someone will make true CRISPR technology because there is no constant money source as if ppl use drugs. And if even follicles will become DHT free by CRISPR, drugs that enable active growth phase must have thing.
To answer your question Admin…. If the results were as good as promised with HSC… and there were no issues with the group releasing is amd it only had to be done once a year or so…
I would go to Mexico….
It may not be a cure as such but it would likely revitalize my follicles to the degree of some thickening and allow me to hold on to what I have for longer in the hope that i wpuld still have viable follicles for when a new regenerative treatmemt came out