Category Archives: Hair Stimulating Complex (HSC)

FDA Approves Histogen IND for Female Hair Loss

Update: Histogen has just kicked off Phase 1 trials for its female hair loss product HSC660. (h/t John Doe). The below post was originally published in May 2018. Also see this 2011 study on Histogen’s Hair Stimulating Complex (HSC). Dr Gail Naughton is a co-author.

When it comes to the speed of progress in a company developing and bringing forth to market a hair loss product, the most disappointing company for me has been Histogen (at least since I first started writing this blog).

Replicel and Follica have also been major letdowns in their speed of progress, although the former is perhaps now reliant on its partner Shiseido for movement, while the latter has made some big statements via its new and improved website during the past year.

In earlier years, the biggest disappointments were Aderans and Intercytex.

Histogen Background

I first covered Histogen in 2013, just a few months after starting this blog. In that post, I said that Histogen’s “male hair loss product (Hair Stimulating Complex — HSC) is in phase 2 trials, while the female product is yet to enter phase 1 trials“. Around the same time, I happened to be in San Diego and even visited Histogen’s offices and very briefly talked to a key staff member. I am clearly into hair.

Note that Histogen’s product supposedly increases hair count via the injection of key growth factors in the form of KGF, VEGF, follistatin, placental growth factor, angiogenin and hepatocyte growth factor.

Since that original post, I have covered Histogen numerous times on this blog, with most developments entailing either 1) Conference presentations from CEO Gail Naughton; or 2) Brief mentions of Histogen getting some new financing and funding. In one of my past posts about Histogen, someone from the company even replied to a reader comment on this blog.

The one exception to the above was this upbeat post from 2016, in which we learnt from Dr. Naughton that Histogen’s HSC treatment would be made available in Mexico first in 2018. They were also planning to soon conduct a large-scale 330-person clinical trial in Mexico with a local partner. They were also close to getting a partner in China for further clinical trials.

In 2017, Dr. Naughton then said the following in an interview:

“The U.S. trials are planned to commence in 2018; we expect it to gain approval in Mexico first, perhaps in 2020, and then in the U.S. sometime after that.”

And now in April 2018, Dr. Naughton said:

“Naughton said Histogen also is moving toward a late-stage clinical trial in Mexico for use of its HCS in men for treating baldness.”

US FDA Approval for Histogen IND for Females

Earlier today, I got a bunch of alerts in my e-mail about Histogen. The big news is that the US FDA has just approved Histogen’s Investigational New Drug (IND) for Female Hair Loss Trial. For those who do not know, an IND is the first step before Phase 1 clinical trials, and primarily focuses on drug safety.

So 11 years after Histogen was founded, they are possibly soon entering Phase 1 clinical trials for their female hair loss product. Makes one want to cry, but perhaps they will be able to speed these trials up due to already having tested the product in males. In their latest press release, they call their Hair Stimulating Complex product “HSC660”.

The only reason I decided to write this post was because of the below encouraging paragraph from this latest press release:

Pilot and Phase 1/2 Clinical Trials of an HSC660 predecessor were completed in male pattern baldness outside the US, with results that produced statistically significant efficacy indicators and a clear safety profile. More recently, a physician-sponsored 10 patient study in the US showed cosmetically significant results in both men and women. In addition to seeing a 100% female responder rate in the physician-sponsored study, previous trials have shown efficacy in other difficult-to-treat populations including men over 40 years of age and temporal recession hair loss.

Histogen’s Update from the Stem Cell on the Mesa Conference

Histogen’s excellent presentation from the Stem Cell on the Mesa Conference is finally available online and I have embedded the youtube video at the end of this post (hair loss related presentation is just under 3 minutes long).  Thanks to “Noisette” for letting me know about this in one of the comments under the above linked post, as well as to “the X” for letting me know in the hair loss chat. Also see Histogen’s presentation from last year.

I am not surprised about Histogen’s decision to get their final clinical trial for its male pattern baldness product done in Japan in early 2015, especially after Shiseido (aka Replicel) announced their intention to start trials in Japan during the first half of 2015.  Since starting this blog, I have frequently discussed the high likelihood of hair loss cures becoming approved in heavily populous Asia before anywhere else in the world, but I always thought that experiments, trials and approvals would be spread across the region, especially in developing countries such as China, India and Thailand. It is truly a wonderful surprise to instead see developed technologically advanced Japan dominating this sphere.

Histogen’s Hair Stimulating Complex (HSC) product seems to be significantly better than Replicel’s product as far as increase in long-term terminal hair counts go, although it was not entirely clear to me whether Replicel’s results were based on using a very low dosage or not, and how much better the results would be with higher doses assuming safety was not compromised.  Histogen’s results indicate efficacy in all areas of the scalp as well as on people over the age of 40.

For the female readers of this blog, the below video also shows that this treatment works for women too!  Although Histogen’s clinical trials (in the US) for women’s hair loss are well behind the trials for men’s hair loss, I wonder if women will be able to access the men’s product (administered via injections) as soon as it is approved and comes out?

FYI — US and EU citizens do not need to get visas to travel to Japan…but maybe I am getting ahead of myself here:-)