RCH-01 – RepliCel’s cell therapy for the treatment of Androgenic Alopecia has been the subject of a successful phase 1 trial in Europe and a clinical study now complete in Japan. Shiseido is expected to announce soon whether it will commercially launch the product in Japan or conduct further development and clinical testing. RepliCel will not plan for a phase 2 clinical trial of this product until it has the RCI-02 injector commercially available to use in such a trial and it has clarity from Shiseido regarding its plans for the product in Japan.
Partnership with Shiseido – The disagreement regarding the status of the agreement between Shiseido and RepliCel remains unresolved but is not the subject of any litigation or arbitration. RepliCel maintains the Agreement remains intact and is communicating with Shiseido regarding its expectation of a release of data from the recently completed study of RCH-01 in Japan and clarity around Shiseido’s commercial plans for the product in Asia (the territory for the Shiseido license).
Dr Tsuji’s method still requires transplantation to human sclap, no? It doesn’t sound like he is actually multiplying stem cells but more like growing tissues in the lab and then implanting to the patient’s skin, that s my understanding from his mice experiment.
Yes, Dr. Tsuji is multiplying stem cells – as well as other cells together with the stem cells. In fact, cell multiplication is critical to the success of his method. How do you think he generates new follicles in vitro? By taking cells from your healthy scalp follicles (in back), multiplying them, and growing them into ‘follicle germs’ in his lab. The follicle germs are like mini follicles and then they are implanted into the scalp. This is the only way you can end up with many more growing terminal follicles than you had before. Without multiplication of cells, he wouldn’t even be able to do any of this.
From a realistic perspective I agree that Tsuji offers the best science hope can generate concerning a real solution to hair loss. Everything else like Replicel with its updates doesn’t look like its cutting it 100%.
That said guys, based on what I’ve read on other forums, wasn’t Tsuji supposed to release this follicular multiplication to the general public by next year, 2020? Correct me if I’m wrong about this.
Here is what Dr. Tsuji said about human clinical trials, posted on another website, on July 18, 2017:
Thank you for your contact regarding our work.
I am grateful that you had read my book and have interests to our hair follicle regeneration. Recently, we successfully developed an expansion method of hair follicle-derived stem cells, although the results are unpublished. We are now trying to challenge of the expansion of human-derived cells and plan to do the clinical application in human at March 2019.
I appreciate that you will continue to watch our study.
So, if he’s still on schedule, that means the human clinical trials are supposed to begin this month.
He has not even started clinical trials and you’re asking when this mega-expensive treatment will be available.
Even if he’s going to come out with decent results, the price for procedure will be 20.000++.
And there will be no shortage of punters.
If Tsuji is able to meet time table projection, it would be the first time in human history that clinical trials met the schedule.
The likelihood that by the end of 2020 you will happily be able to get rid of your 50.000 dollars to get this procedure done is very very very very low.
Japan has a new fast-track for approval of cell-based procedures like this, which I understand is supposed to be 1-2 years from the conclusion of clinical trials.
A lot has been said about a US $20,000 figure. Yes, that may be true, but then again, people spend $20K on regular hair transplants without blinking an eye. Also, I am sure that there will be financing options (just like you finance your car, and also available on many kinds of cosmetic medical procedures), so that maybe you’ll be able to pay something like $1000 a month. Another thing that hasn’t really been mentioned is that the ultimate price you pay will be related to the amount of coverage you need. Some people might only need $5000 worth of coverage. Some people might want $30,000 worth. Price will probably be on a case-by-case basis.
The big problem for many people in North America or Europe will not be the cost of the procedure itself, but the need to travel to Asia multiple times or stay there for extended periods of time. For the first few years after it’s approved in Japan/Asia, you literally might only be able to get this procedure done in Asia, because US and European regulators will take a longer time to study and approve it. The big cost to patients outside of Asia might be the need to travel to Asia and make regular trips there, staying there for maybe a week or several weeks (or months) at a time. For instance, think about this: First, there is the extraction step. You have to be present for that. Second, there is the multiplication step. That takes place in the lab. You DON’T have to be present for that, so you can go back home for maybe 6 weeks to 2-3 months while the cells are multiplying and the follicle germs are forming. Third, there is the implantation step, where the follicle germs are implanted into your scalp. Since you have to be present in the clinic for the first and third steps, which are probably separated by about 6-12 weeks, then that will mean that you either MUST travel to Japan (or somewhere in Asia) twice within that period of time, OR you could stay in Asia for the entire period. How many Americans have the time and money to do that? Your only other option is to wait the maybe 5 or more additional years until the procedure is approved in the US.
Here’s what Dr. Tsuji is doing with his method , good read if you can’t sleep at night, to summarize:
"In this study, we successfully demonstrate fully functional bioengineered hair follicle regeneration that produces follicles that can repeat the hair cycle, connect properly with surrounding skin tissues and achieve piloerection. This regeneration occurs through the rearrangement of various follicular stem cells and their niches. These findings significantly advance the technological development of bioengineered hair follicle regenerative therapy…
Properties of the hair shaft, which reflect the function of the hair in the body region, are regulated by hair follicle mesenchymal DP and DS cells and are also modulated by the expression of various genes in the epidermis. It is also thought that hair pigmentation is controlled by melanocyte differentiation and the proliferation of melanocyte-lineage stem cells below the bulge region. Thus, hair properties can be controlled by the arrangement of cell types during the regeneration of the bioengineered hair follicle germ. We provide evidence for this arrangement by showing that bioengineered hair with a proper shape and colour can be generated through the appropriate cell populations, such as bulge-derived epithelial cells, DP cells, and the PHM region-derived cells, but not sebaceous gland region-derived cells. Our findings thus provide new insights into the regulation of hair properties and strongly suggest that these characteristics could be properly restored by cell processing for organ regeneration and by the transplantation of bioengineered hair follicle germ.
In conclusion, this study provides novel evidence of fully functional hair follicle regeneration through the rearrangement of various stem cells and their niches in bioengineered hair follicles."
Wow!! Damn good news. About time too. But the problem with this is the human trials can last a while. On top of that theres a drug approval process which will take more years I assume.
In other words this wont be ready to the general public by 2020. Most likely 2030.
Under Japan’s new SAKIGAKE approval pathway, approval times for drugs and biological products (like cell therapies) is supposed to be much faster… Here’s a summary of the Sakigake pathway:
It’s my recollection that these types of cell-based therapies are supposed to be marketable after the successful completion of phase 1 (ONE) human clinical trials. Further testing would have to continue but the product could be sold to patients after phase 1. I believe that if the trial starts in March 2019 then the product could hit the market in Japan as soon as late 2020.
My recollection is that the right cell-based treatments can hit the market in Asia after the first human trial but the testing also has to continue.
If it starts human trials in the next few months then it could almost reach the market in America in 3 or 4 years but it could hit the market in Japan in 2020 IMHO.
Yes, and also while approval in the US will take longer than in Japan, for the Tsuji procedure (and anything similar) there will also be behind-the-scenes pressure by the HT industry to approve it.
Normally we can be assured that the HT industry is pressuring the FDA to be very skeptical of anything that would compete with HT, and to take a long time reviewing anything like cell-based alternative treatments, but in this case it will have to be regular HT surgeons who administer the treatment. They will have to license the treatment somehow from Dr. Tsuji and RIKEN, so it will be very popular with HT docs. I believe they’ll push for the FDA to approve it as quickly as possible.
The thread has morphed into a discussion about Dr. Tsuji’s research, so your thread title was revised to reflect that. No other changes were made other than that.
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