Stemcell is indeed looking at Asia (and other countries) to initiate human trials

  1. In the recent past there was some debate here as to whether Stemsom would do human trials in the UK or Asia initially. I stated that Stemson wouldn’t rule out Japan because they have a very fast approval process for cell-based therapies while other posters indicated the initial trials would be in the UK.

  2. In the recent past there was also debate about how Stemcell could possibly be altered to make them more resistant to androgens so they wouldn’t fail so quickly. I stated that Stemson should try to make the new hairs more DHT resistant and some other posters didn’t think that was a viable possibility.

Stemson is now reporting that they are considering multiple countries, including Japan, as potential places to initiate human studies and that the approval speed is something Stemson will consider when making the decision about which country they’ll start human trials in.

Stemson is also reporting that they are trying to figure out ways to make their “new” follicles more DHT resistant.

https://www.folliclethought.com/interview-with-stemson-therapeutics-ceo-geoff-hamilton/

@jarjarbinx I saw that interview with Geoffrey Hamilton, too, I just want to say regarding Japan, I think the they’ve been all talk and no action, in respect to their so-called “fast track”.

Why do I think this? Look how they kept Dr Tsuji in limbo for like 2-1/2 years. Sure, maybe some of that was Tsuji’s fault because he was hyping his technology but it wasn’t really ready for prime time, but I think some of that was the Japanese PMDA agency’s fault. Tsuji was associated with the most prominent, highly respected research organisation in Japan, RIKEN, and he still couldn’t get them to approve starting some kind of clinical trial? How lame is that?

The other problem about Japan is that I think they have a sort of unofficial policy of giving preference to Japanese-owned companies in certain high tech or emerging tech sectors. This may or may not be codified into their laws but I think it’s how the game is actually played in Japan. “You scratch my back, I’ll scratch yours…” (As long as you’re Japanese owned). And the fact that Tsuji, who is actually Japanese, couldn’t even get to clinical trials (or hasn’t reached this milestone yet after more than 3 years of hype) tells me that Japan’s fast track policy isn’t really what it’s touted as. It looks like they still set the bar very high and it’s just as hard to get your foot in the door as it ever was. (And just because Shiseido and Replicel managed to do it doesn’t mean anything, because they likely had a lot more money available to grease the skids. Tsuji was begging for donations from the public just a few months ago.)

I think Stemson might have a better time trying this in Korea, Singapore or Australia if we’re talking about Asia.

But I really suspect they will do it in the UK. My honest opinion about the UK is the that they’re very strict about regulations and the approval process too, just like the US and Japan, but they are giving financial incentives to foreign companies to base in the UK or conduct scientific research there, because of Brexit. Brexit cut them off from many of their formerly lucrative tech and business ties to Europe, so now they’re kind of trying to lure in almost everything good they can get their hands on from abroad. I think they will pay or offer financial incentives to companies just to invest or base their ops in the UK. I think the UK will probably offer one of the better deals to Stemson, possibly the best.

I’m looking at this and I think the Japanese “fast track” is a big fake out, it exists on paper only, it’s not about loosening any regulations at all, their regulatory standards have not changed one bit and I suspect this is also a door open ONLY to Japanese-owned companies, owned and operated by Japanese, NO EXCEPTIONS.

I don’t think Tsuji’s difficulties starting hair loss human trials in Japan indicate that Japan’s fast track for cell-based treatments is fake. I think that has more to do with Tsuji’s technology not being ready. If his tech was ready he wouldn’t have any trouble getting big investors but instead he’s seeking money from guys like you and I. He never really had a good response when asked about his solution to the inductiviy problem. He just said he has a number of ideas for the problem. I’ve lost faith in him. And now Tsuji is hawking a hair care line.

Stemson is a totally different animal. They have the inductivity problem solved and cell-based hair growth is their focus, not raising money via hair-care lines.

The main reason I don’t trust Japan’s fast track is because of Replicel/Shiseido’s lack of progress. Replicel started its partnership with Shiseido to develop cell based hair growth treatment in Japan in 2013! It’s now been 8 years.

I understand they have a very weak technology with apparently very poor clinical trial results so far. But even with the poor results, they’ve stayed in the game pursuing further Japanese clinical trials. I assume theyre doing this in Japan because they want their treatment to hit the commercial market as soon as possible, even if it gives poor results. (Rogaine gives poor results for the most part, but that didn’t stop Upjohn from putting it on the market.)

Replicel’s product may suck, but its sucky-ness probably isn’t causing the slowdown. The most probable reason for the slowdown leading to an 8 year wait with little progress seems to be with the Japanese PMDA not Replicel.

The same thing that applies to Tsuji also applies to Replicel/Shiseido. IMO neither of these technologies are ready for primetime. IMO these fools are trying to use implanted cells to regrow hair but these fools have not solved the inductivity problem. These guys are trying to do the same things that intercytex and Aderans tried to do - grow hair via implanted cell therapies without solving the inductivity problem first. IMO that’s why these groups can’t get anywhere. Their results are shit because they can’t preserve hair inductivity in the cells.

Stemcell is a different animal. They have a solution to the inductivity problem. Once they’re finished with animal studies they could move to human studies and then get approval rapidly.

I also found the literature wherein Kintor pharmaceuticals said that they have a topical anti-androgen that works topically without getting into the body. I will make a new thread to share that info with you (and everyone else here) at the top of the page. Check it out.

Ah, Roger, your skepticism about the Japan rapid approval process is unwarranted. Tsuj got approval from the Japan Ministry of Health to conduct human trials for hair loss with his cell-based treatment about a year and a half ago. He has begun human trials. It would appear that Mr. Tsuji is just a very secretive man and he has been holding his cards close to his vest. I am now more confident than ever that Stemson will run their trials wherever they can get their treatment to market the fastest.

https://inf.news/en/science/160051c60a9cc925f5c1cba615504fdc.html

From what I read, Tsuji’s debacle is more a problem with his execution rather than the government.

Typo in the post heading? Stemson instead of Stemcell?

You have an unhealthy obsession thinking that DHT is the one and only reason for hair loss. I suspect DHT plays a much smaller role in hair loss than what we were led \to believe.

I never said DHT is the sole reason for hair loss. In fact, genetics + all androgens are the cause of hair loss.

That’s good news, anywhere but the US unless Stemson can get EUA like Pfizer or Moderna :slight_smile:

Is Stemson the only player left? We have given up on Replicel , Histogen, Tsuji ?

Histogen is officially dead for hair loss at least, the company recently announced that they have discontinued hair loss research and their work developing the hair growth product! The company will continue and they are still researching unrelated medical products.