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Another cell-based treatment heading for human trials in fast-track Asia

J Hewitt, a Japanese regenerative company, is starting clinical trials BY December 2019 in Japan using TissUse SHT technology. J. Hewitt’s ambitious CEO hopes to fast track the treatment in Asia but how soon after starting trials could they commercialise the treatment and how long would the trial take?

TissUse SHT technology is similar to Intercytex except TissUse SHT tech involves inductive DP cells and other cells whereas Intercytex used DP cells that were non-inductive and they only used DP cells.

Could this be the big one we’ve all been waiting for and could this put pressure on Shiseido to get the lead out?

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Good find! From the description, that looks really hopeful. So if it’s like Intercytex, does that mean they’ll be injecting cells rather than implanting follicle germs?

Looks like a German company licensed the technology to that Japanese company - See press release “TissUse grants first Smart Hair Transplant (SHT) License in Japan”

https://www.tissuse.com/en/news/press-releases/

It’s my understanding that they’re going to inject cells rather than follicles. It sounds like it’s exactly the experiment that you want someone to do. I hope it works. If it does I think it might be even better than Tsuji because the treatment/cells might incorporate your existing follicles as part of the cure by enlarging them. If that’s the case then you might not have to worry about things like angle and direction. Roger, do you remember if Jahoda’s experiment on his arm produced NEW follicles or re-invigorated miniaturized follicles?

I would still have some questions though.

Once the cells are injected sooner or later the miniaturized follicles will absorb their fill of the newly injected cells. What happens after as many cells as possible hook-up with existing miniaturized follicles? Where do the extra injected cells in your scalp skin go? Wherever the leftovers end up what do they do there?

And once a follicle absorbs as many cells as possible what happens when that limited number of cells are used up in the hair-making process? Does the new hair just fall out immediately because it won’t be getting infused with new cells anymore?

The follicles can only store so many cells so could the superfluous cells sit in the scalp skin until the follicles needs them?

I’m glad this experiment is about to be done. We will get some answers to some questions.

I think that the scientists involved with TissUse were at one of the Hair Loss Congresses.

Yes, the scientists from TissUse include Dr. Roland Lauster from the University of Berlin who has been researching hair regeneration for years. They have been very quiet for a while but the direction of his research was creating proto hair follicles like Tsuji, not injecting cells. He is on the board of advisers of TissUse and his colleague Dr. Uwe Marx is in the board of directors.

TissUse licensed its “Smart Hair Transplant” technology to J. Hewitt in Japan. J. Hewitt is a medical device and equipment firm based in Japan but the CEO is American, Dr. Jon Knight. They specialize in medical devices for dermatologists and cosmetic surgeons.

We hadn’t heard anything from Dr Lauster in quite a while. His initial research looked very promising, and this really answers a lot of questions about what Dr Lauster has been doing lately.

Maybe this treatment entering a phase 1 human study involves cloned follicles rather than hair cells. I’ll try to get more information about whether it involves re-injecting cells or implanting follicles.

Great news.

Nothing is said in this article about the techniques used in DP cells’ preservation process. But I could not imagine they are applying the same methods that have been applied by aderans or intercytex.

And they are injecting DP cells as opposed to growing hair germs in vitro.

Is it enough to have just inductive DP cells to induce new hair follicle formation? Jahoda proved is enough.

Here is an article about Jahoda and his cell experiment on his wife. Remember these were NOT cultured cells.

https://www.nature.com/news/1999/991104/full/news991104-12.html

Thanks for the article Roger.

Yea, the cells in Jahoda’s experiment weren’t cultured and that proved that uncultured hair cells can grow hair?

And attempts by Aderans and Intercytex proved that for some reason cultured hair cells can’t grow hair.

And Jahoda/Christiano teamed up much more recently and grew some partial follicles from cultured hair cells by using 3-d drops to PARTIALLY protect inductivity. In that study Jahoda/Chrstiano analyzed the cells both pre-culture and post-culture and it’s my recollection that they were able to determine how much inductivity was lost and how much was preserved during culture. I recall that their analysis showed that they were only able to partially preserve inductivity. And if their partial preservation of inductivity resulted in a corresponding creation of partial follicles didn’t this prove that protecting inductivity is key to growing follicles?

I mean, here’s how I see it: A) for some reason harvested hair cells lose the ability to create follicles after culture so you can’t grow follicles using cultured cells. B) If you partially protect inductivity during culture, harvested hair cells can then produce partial follicles. C. Since you can create partial follicles with partially induced cultured cells that means by preserving ALL inductivity during culture there is a real possibility that you might be able to produce complete follicles.

Jarjar Yes, I think you’re basically right on all that.

A couple of things to add: Stemson has found a way AROUND the inductivity problem. The cells they’re making are DP cells generated from iPS cells and these DP cells are inductive. Since they can grow a lot of iPS (multiply them in culture) that’s how they’re able to come up with unlimited amounts of inductive cells. So I consider that as having solved the inductivity problem.

Now, the next step is what do you do with all those inductive cells? Stemson is focusing on growing them in vitro into proto follicles which are then implanted. That’s great, and they should continue to do that… if all that pans out, it will be a cure.

Another route they should try is just taking those inductive DP cells they make from the iPS cells and inject them straight into patients’ scalps… as an alternate therapy. This would be a cheaper treatment, and probably quicker to get approved. It doesn’t require follicle implantation by a skilled surgeon, it could be done by any doctor or even a nurse or physician’s assistant in a clinic.

Now, the advantage of making proto follicles and implanting them is that it’s essentially “hair made to order”… So you could go to your doctor and say, “I want 10,000 new hairs right here” and you would be sure of getting 10,000 new hairs. They make as many new hair follicles as you want and you’re guaranteed of getting exactly that number.

With injections, it’s going to be somewhat of a crap shoot because for every injection you get, there is no real GUARANTEE of getting hair from it.

But injection of cells known to be inductive is sure to be a lot more reliable and predictable of growing hair, than injection of non-inductive cells which is what Aderans and Intercytex were doing.

So, I think in addition to making proto follicles, Stemson should also pursue cell injection as another option. It would be a cheaper option for patients, probably quicker to get through the approval process, etc. It wouldn’t work as well as proto follicles grown in the lab but it would probably be good, and probably much better for a lot of people than any of the current approved treatments like minox, propecia, etc.

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And Roger, now that Stemson has completed a study using mouse and human biologics combined I’m sure that the Asian regulatory agency would let them now try injecting strictly human biologics into human scalps because that’s the next step after the things they have already achieved. But Stemson isn’t even thinking of that. What is their problem already?

How can we have a conversation with Stemson. It seems like now would be a good time to request a Q& A with Stemson so we can run the idea by them. We need to explain this stuff to them.

You and I both agree that they should try this NOW but it does no good for us to know it. We have to get this idea into the hands/ears/minds of Stemson.

We’ve talked before that if cells are injected then perhaps there might not be much regrowth because the cells could have a hard time getting into follicles after the cells get injected into the scalp. But since Jahoda’s injected cells grew hair doesn’t that mean that injected cells not getting into follicles is not really a big problem. Isn’t it possible that INDUCED cells are biologically attracted to follicles so the cells induced cells could maybe perhaps migrate to the follicles?

I think if you have fully inductive cells, it wouldn’t matter as much.

One thing I learned in biology is that on the cellular scale, which is incredibly small, but with incredibly large numbers of cells involved, is that you have to think of EVERYTHING that happens on a statistical basis. You have to think of tens of millions of cells moving into the skin, and a Bell-curve distribition of where they will go and what happens to them.

In any typical cell injection, you might be injecting tens of millions of cells, say 50 million. Let’s say 40 million drift away from the follicle so they’re essentially wasted and get flushed out by the blood and lymph. 10 million come very close to the “sweet spot” of the follicle (the bottom, near the dermal papilla), but only 2 million actually hit that part follicle and of those, only 1 million or less stick to it.

Now if the cells are poorly inductive, like Aderans’ and Intercytx’s cells, that means that say out of 10 million cells, maybe only 1 million are inductive and 9 million are waste.

But with Stemson’s cells, maybe out of 10 million, 8 or 9 million are inductive and 1-2 million are not.

Let’s say it takes at least 500,000 to 1 million inductive cells to hit and convert a follicle from miniature to terminal.

Because EVERYTHING in cell biology is based on statistics, and I mean everything.

So if you inject the poorly inductive cell culture from Aderans, 9/10 are waste from the get-go, so with the high attrition rate of injected cells tending not to hit and stick to their targets, as I mentioned above, and the poor fraction of inductive cells in the population, you will get an extremely low yield. You might grow 1 or 2 hairs after many injections and get really frustrated and just give up, which is what they did.

But with Stemson’s cells, they are not shooting duds, so despite the inherent very low rate of injected cells hitting and sticking to their targets, the fraction of inductive cells in the population is very high, so the ones that do hit and stick will almost certainly be inductive.

EVERYTHING in cell biology is about populations and statistics!

Great!

I am so looking forward to the upcoming trial.