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RepliCel RCH-01 cell based hair loss treatment - 2017 forecast


#1

RepliCel’s latest update on RCH-01.

For those who are new to our community: RCH-01 is a cell based hair restoration procedure using dermal sheath cup (DSC) cells harvested from the patient’s donor follicles, usually from the back of the patient’s scalp. The harvested cells will then be multiplied and injected into the balding areas of the patient’s scalp. If successful, this treatment could potentially eliminate the need for invasive hair transplant surgery.

Below are excerpts from RepliCel’s 2017 forecast which some of you may find interesting:

In 2012, when we announced the safety and 6-month clinical efficacy data from our phase 1 study of RCH-01 (pattern baldness), we knew that in 2017 we would have 5-year safety data and both 12 and 24-month efficacy data which was all locked until the completion of the 5-year trial (all the trial participant data needed for this announcement has been collected and is now being prepared for third-party analysis)

In Japan, we are pleased Shiseido continues to fund the two-site clinical research study for pattern baldness (RCH-01)… We look forward to data from the Japanese RCH-01 (pattern baldness) study anticipated sometime in 2018 and continue to develop our own plans around the asset for markets outside Asia.

You can read the full forecast on their website at http://replicel.com/replicel-ceo-provides-2017-forecast/


#2

They forecast treatment will be available in 2017? yes?


#3

@HairSite care to explain why you have conveniently left out the following very important information from Replicel’s forecast statement? This sounds serious and could mean the end of their hair regeneration partnership.

"In Japan, we are pleased Shiseido continues to fund the two-site clinical research study for pattern baldness (RCH-01). While our relationship continues to be troubled to the point of alleged breach and termination, there has been no litigation, arbitration or other dispute resolution triggered. We continue to maintain our position that the agreement and relationship remains in good standing. Recent correspondence suggests the possibility of resuming discussions between the parties under certain conditions. "


#4

Really bad situation between Replicel and Shiseido. In their agreement, Replicel promised Shiseido data from phase II, etc. clinical trials. Replicel hasn’t provided that data (I think they said the subsequent clinical trials were delayed for some reason). Now Replicel has written off any royalties from the release of the product in Asia (apparently there was a clause in their contract that made a share of revenues for Replicel contingent on certain deliverables). So now Replicel is going to write off any revenues from Asia… which removes some of their incentives to work fast on this project, because likely the FDA won’t approve it anytime soon. On the other hand, under Trump with possible reforms to the FDA (pushing cosmetic procedures onto a faster track), things might be different. We’ll see…


#5

I think, shiseido don’t need that much data from replicel since they are working with IPS cells.
Replicel essentially are doing what intercytex and aderans did. So they are heading for the same conclusion. First phase results indicated just that. Apart from replicel’s patented hair punch extractor, I can’t see how they could help shiseido.


#6

The Replicel project in conjunction with Shiseido uses DSC cells. There is another HM project in Japan between Kyocera, Riken and Organ Technologies (3 Japanese companies) which uses iPSC cells. It’s unclear whether Shiseido is involved in that one, but there seems to be some kind of connection at least in some media stories. If that is not true, then the media is reporting about the 2 projects in the same reports, which I think is confusing people…


#7

Hi everybody. I’ve been gone for awhile because I wanted to give Hairsite a chance to get everything under control here before posting again. I don’t know why they changed the site but that’s just how some people are I guess - they aren’t happy unless they’re messing with stuff. As far as I’m concerned the site was perfectly
satisfactory before they went through all of the expense and trouble of changing things.

All that aside, I really think Replicel’s foolishness with Shiseido is making them look kind of silly. That aside, I do have some hopes for Replicel but I was underwhelmed by their phase 1 study results. Still, I do want to see their 12-month and 24-month results.

In the near-term I’m also looking forward to Pilofocus’s donor regeneration results. I think they will probably achieve good quality donor regeneration.

I’m hoping that Pilofocus + Replicel will give almost all of us a permanent solution to our hair loss.


#8

Where did you get the idea that it will be available this year? Read the link again, they are forecasting they will collect trial data from the Japanese in 2018 so we are talking about 2019 the earliest and that is assuming you don’t mind traveling to Japan.


#9

OK maybe it won’t be marketed until 2019 but they haven’t changed their timeline to market from 2018 so I’ll still think there’s a chance that it might hit the market by 2018. And I’m cool with flying to Japan.


#10

RepliCel might be available in the US a lot sooner than you thought. Their CEO is pretty upbeat about the new 21st Century Cures Act according to this article:

"The Act provides for any product designated as a “regenerative advanced therapy” to be the beneficiary of ‘priority review’ by the FDA. The Act mandates the FDA to define a pathway for ‘accelerated approval’ for products designated as ‘regenerative advanced therapies’…this translates inevitably into a shorter clinical development pathway resulting in regenerative medicine products getting faster-to-market and the companies quicker-to-revenue. "


#11

2019 is less than 2 years away, does anyone know how much the treatment cost? Is it permanent?


#12

According to a Mar 2016 press release, it is estimated that the treatment will cost about US$1,000.


#13

I would not put too many expectations into Replicel data. Unless they incorporated use of IPSC cells into their newer protocol, there is very high probability they will come out with similar results of those in phase one. I’m more interested in Shiseido trials data. I believe, I hope, they are using IPSC cells. Apart from culturing dermal DSCC cells, in my humble opinion, I would assume they might be topping up cultured medium with IPSC cells to recover trichogenic properties of the rest of the cells.
I don’t believe, just by culturing DP or DSCC cells and knowing where all that ended up in Intercytex, Aderans case, someone would have had courage to announce they have cure in 2018.
All in all, just the thought that next year we might start our journey to recovery, sounds incredible.
What do you think Roger, jajar?


#14

My view is that if Replicel can’t do its Phase II clinical trials because of financial problems, then there is probably a serious deficiency in the technology. If the technology were effective, it would produce good results and Replicel would have no trouble raising money from investors. If Replicel has been able to raise the needed money, they’d be able to do Phase II clinical trials and not breach their contract with Shiseido. But Shiseido is apparently accusing them of breaching the agreement. To me, it all has to go back to the technology.


#15

I have been reading this and other trials with interest, the thing is that we don’t know what the breach is about, do we?


#16

The alleged breach is a violation of a term in the agreement that requires that Replicel provide to Shiseido the data from Replicel’s clinical trials. These were expected to be done by a certain time. Replicel has publicly admitted that it hasn’t done those Phase II trials, and they even admitted the reason was their own financial issues. So that much is out in the open, from Replicel’s own public communications.


#17

Hairsite posted -
For those who are new to our community: RCH-01 is a cell based hair restoration procedure using dermal sheath cup (DSC) cells harvested from the patient’s donor follicles, usually from the back of the patient’s scalp. The harvested cells will then be multiplied and injected into the balding areas of the patient’s scalp. If successful, this treatment could potentially eliminate the need for invasive hair transplant surgery…

My response-
Why would we expect these cells to perform any better than the cells Aderans used? The cells Aderans used failed because they lose hair inductivity in mass pass culture. Why wouldn’t the same thing happen with these Replicel sheath cells?


#18

Good point Roger.

And I wonder if the technology deficiency could be that the sheath cells Replicel uses lose hair inductivity during mass pass culture the same as the DP cells Aderans used did? Why would we expect these sheath cells to retain hair inductivity any better than the cells used by Aderans did?


#19

Aderans used DP while Replicel uses DSC. According to Dr. Berstein’s site, DP cells die over time but DSC are long lived and self renewing,

https://www.bernsteinmedical.com/research/dermal-sheath-cup-stem-cells-hair-growth-cycle/

"The number of dermal papilla (DP) cells in a hair follicle has been found to be a determining factor as to when the anagen (growth) phase of the hair cycle is initiated.[2] The gradual loss of DP cells over time results in a longer delay in the onset of the anagen phase; a longer telogen (resting) phase; and a hair follicle that shrivels and eventually disappears.

While dermal sheath cup (DSC) stem cells are known to be long-lived and self-renewing, it is not fully understood how they replicate or why the pool of DSC cells becomes depleted over time. We do know, however, that the gradual loss of DSC cells results in a failure to produce the necessary number of DP cells. And without enough DP cells to trigger the anagen phase, the follicle begins to miniaturize. It is clear that maintaining the population of DSC cells after each iteration of the hair cycle is very important in preserving and maintaining healthy and mature terminal hairs."


#20

All that makes it sound like fairly frequent/regular reapplications will be necessary. That’s not necessarily a horrible thing, but if people think one application will permanently fix their follicles, that’s probably off the mark.

Jarjar- yes, I kind of agree but it may be a bit more complicated than that. The DSC cells seem to be the “deepest” cells, at the very bottom of the follicle. As they multiply, their offspring turn into DP cells, which are like the cellular “fuel” of the follicle. The problems with DP cells (losing trichogenicity after multiple passes) might not be exactly the same problem as the ones DSCs have. Could be similar problems but maybe not exactly the same.