Replicel Update - Oct. 22, 2014 Presentation

[HairShocka]

RepliCel's proposed Phase 2 trial will enroll 160 male subjects in good health with mild to moderate androgenetic alopecia. DSC cells will be isolated from a small punch biopsy taken from the back of the subject's scalp. These cells will be replicated and then reintroduced into balding areas on the subject's scalp. After injections are performed, subjects will return to the clinic for assessment of total, terminal and vellus hair density and cumulative hair thickness, as well safety. Participants will remain in the trial for approximately 39 months.

http://www.cnbc.com/id/102288358


3 years and 3 months in trial. I think I heard people saying Replicel could be available in 3 years but that sounds unlikely. Maybe in Japan in 3 - 4 years. Maybe.

 

[hellouser]

RepliCel's proposed Phase 2 trial will enroll 160 male subjects in good health with mild to moderate androgenetic alopecia. DSC cells will be isolated from a small punch biopsy taken from the back of the subject's scalp. These cells will be replicated and then reintroduced into balding areas on the subject's scalp. After injections are performed, subjects will return to the clinic for assessment of total, terminal and vellus hair density and cumulative hair thickness, as well safety. Participants will remain in the trial for approximately 39 months.

http://www.cnbc.com/id/102288358


3 years and 3 months in trial. I think I heard people saying Replicel could be available in 3 years but that sounds unlikely. Maybe in Japan in 3 - 4 years. Maybe.

Japan's new legislation allows for a conditional commercial release DURING phase 2 trials. This is not up for debate, this is a fact. Whats up for debate is if Shiseido will give enough of a sh!t to actually take advantage of the opportunity and let us balding brothers take advantage of the treatment sooner rather than later.

 

[macbeth81]

Phase I dosage was high. They have never responded regarding whether a higher dosage will be used in Phase II, so the safe assumption is NO. They stated they improved the cell culturing method, but also stated they had issues which caused the delay in Phase II. That doesn't give much confidence. We may not see any improvement from Phase I from a single treatment.

Hopefully, it can be compoundable and affordable. Totally reversing hair loss with a single treatment is probably not realistic anyway.

This is disheartening concerning the science demonstrates this should work. What always confused me though was that the original paper, and experiment on mice, used wounding in conjunction with DSC cell injections and stated it was the better approach. Yet with all the talk regarding wounding since Follica, they have not attempted it on humans. They are effectively testing a known (on mice) suboptimal treatment protocol.

 

[long_hair]

news of today 23rd December:

http://phys.org/news/2014-12-hair-growth-skin.html

http://www.eurekalert.org/pub_releases/2014-12/cndi-cra121914.php

What do you think about that? Is this Spanish study comparable to the work that Replicel is doing?

 

[dps]

any update?

 

[ma12199]

"Thank you for your email and interest in the potential product we are developing and testing for the treatment of pattern baldness. We are as anxious as you to see this through the required development/testing stages and approvals to get the product available on the market. We did have, as you may know, some manufacturing issues to resolve which slowed down our progression to the phase 2 trial considerably. This has now been resolved and we are ready, once again, to go full speed ahead with clinical development and testing. We are also pleased that Shiseido now has their manufacturing facility ready and has validated their ability to manufacture the product meaning they anticipate also being able to proceed shortly with their own trial in Japan concurrent with ours. While 2014 was a year of re-tooling, 2015 will be all about moving forward as quickly as possible on both clinical trials for RCH-01 for pattern baldness in addition to our other clinical trials.

As for the phase 1 trial results, it is important to understand that the purpose of a phase 1 trial is to prove that your product is safe. We injected a very high dosage of RCH-01 into each patient and no adverse events were recorded. Now that we have proven the product is safe, the phase 2 trial is designed to determine the optimum dose and frequency. Our phase 2 trial will include approx. 160 patients. We will be injecting approx. 396 sites with RCH-01 and approx. 244 with placebo. This data will give us a clear indication of efficacy.

In our phase 1 trial only 18 patients were injected with a very high dose of RCH-01. The primary objective of our phase 1 study was to assess the local (at treatment sites) safety profile of injections of autologous dermal sheath cup cells (DSCC) at 6 months post-injection compared to control. Secondary objectives were to assess systemic (overall) safety, local safety, and efficacy at 24 months post-injection. The safety data collected from study participants 12-months after receipt of injections of verum and control revealed that the RepliCelâ„¢ treatment was very safe and well-tolerated. This data, coupled with positive increases in hair growth efficacy measured at 6-months post-injection, provided support for the Company to move forward with the development of its Phase 2 dosing trial. Safety only will continue to be monitored on these patients for a total of 5 years post injection.

We remain extremely optimistic about the potential of RCH-01 as a treatment for pattern baldness and expect to start our phase 2 trial this year."

 

[benjt]

ma12199, thanks for the initiative you're showing. RepliCel's response was only very general, nothing too specific unfortunately.

Did you ask about projected market availability?

 

[maher]

I'm little confused but why are they referring to RCH-01 as a product? as if they gonna launch it of the production line.

 

[Joxy]

Replicel conversation with some user from BTT.

The following is a conversation I had with replicel. They very kindly answered all my questions, and their reply gives me a lot more hope for their treatment. These trials can't start soon enough. The gist of the info is that it's probably not going to be a treatment that is great for bald areas (at least not in it's current iteration), but will hopefully really help those who are thinning and want to maintain. Here ya go, you're welcome.


******************
I have a question about RCH-01. It has been shown that as follicles miniaturize in balding scalp, they form a fibrotic tissue around the follicle (as early as 30 months from commencement of balding). How does replicel's technique aim to achieve the rehabilitation of these follicles when they are encased in scar tissue (wouldn't it make it impossible for fresh DSC cells to "find" the existing follicles?, and also when other cells besides the DSC are still androgen sensitive, continuing to promote inflammation? Replicel's video states that new DSC cells might form new follicles, but wouldn't this only be possible if non androgen sensitive DP and other cells existed in the area? I understand that replicel might be able to revive follicles that have barely begun to miniaturize, but in recent interviews your CEO mentioned that he aims for this to be a "cure" which could restore bald areas. I find this perplexing given what is known about the balding process, but perhaps I'm wrong? It seems as if you are hesitant to answer any technical questions but any input would be much appreciated. thank you

************************************
"Thank you for your very astute inquiries. As you will appreciate, your questions will likely only be answered with any certainty by data from clinical trials. Clinical evidence will help us determine the extent to which our treatment succeeds, fails, and/or how it may be modified to improve results.

Our current hypotheses is as follows:

1) Fibrotic tissue. This is variable between different people. Some have quite a lot, others very little. In general, fibrosis increases with the progression of Androgenetic Alopecia. We are proposing that our phase 2 clinical trial will be tested on people with thinning hair --not extensively bald -- so these people generally do not have a significant degree of fibrosis. The main objective of the study is to have the injected cells migrate to, integrate with, and enlarge the resident follicles. Fibrosis could be a challenge for the injected cells, however, the DSC cells do express some matrix metalloproteinases, albeit at a lower level compared to ordinary fibroblasts. We have observed in cell culture studies that the DSCs will migrate through collagen sheets in response to a chemoattraction gradient. The full answer will only be known when we examine the tissue biopsies from people in the phase 2 trials.

2) Androgen sensitive cells. Androgen sensitive cells will be present in the resident hair follicles of people suffering from Androgenetic Alopecia. However, the DSC cells injected are derived from follicles at the back of the scalp that are androgen insensitive. The objective is to introduce enough DSC cells to the follicle that the properties of the injected cells are dominant. Over time, as the resident androgen sensitive hair follicle cells become senescent/die off, we anticipate the DSC cells will become progressively more dominant. Recent evidence indicates that a subset of cells in the cup region are responsible for repopulating other HF cells including DP (Rahmani et al. Developmental Cell. 2014 Dec; 31: 543-58). In theory, the injected ‘androgen insensitive’ DSC cells can repopulate DS and DP with ‘androgen insensitive’ cells.

In addition, the healthy DSC cells express immunoregulatory factors and so should help to reduce any local inflammation which in turn should help reduce or stop further fibrosis. We published a paper on some of our work on DSC immunoregulation last year. (Wang et al. Hair follicle mesenchyme-associated PD-L1 regulates T-cell activation induced apoptosis: a potential mechanism of immune privilege. J Invest Dermatol. 2014 Mar;134(3):736-45).

3) New follicle formation. In principle, with new follicle formation, the issue of fibrosis around pre-existing follicles is not relevant. The injected DSC cells may directly interact with non-follicular epithelium to make new follicles. In such cases, as the DSC are immunoregulatory and not androgen sensitive, any new follicles would have the same properties. However, it is expected that this will NOT be the mechanism of treatment in the planned phase 2 trial. Due to the methodology employed using our injector device, and because we will be injecting people with thinning hair and not extensively bald people, it is simple migration of cells to resident follicles and their subsequent enlargement which is expected.

We anticipate our treatment may be a cure in that it should produce permanent improvement - once the injections are complete we believe there should be no need for further treatment. For people with extensive baldness of many years duration, we will need to conduct a separate study. It is likely that extensive, long-term duration Androgenetic Alopecia will need different cell dosages and changes to the parameters of our injection device.

For corporate, competitive reasons we do not always publish our data but research is ongoing at RepliCel and many improvements have been made in response to the data we obtained from the phase I trial and subsequent studies. We are excited to glean the data from our next phase of trials (both ours and that of Shiseido).

We hope these answers helps and appreciate your continued support and engagement.

 

[benjt]

Thank you, Joxy! Quite an interesting read indeed.

Could you ask the guy at BTT, as he already has an "open channel", to ask them about projected patient availability in a follow up email? I tried asking via their facebook page but unfortunately got no response. I think this info is the most crucial for many people here, as it influences the decision whether to get a hair transplant or hold off till RepliCel's RCH-01 becomes available.

 

[Joxy]

Thank you, Joxy! Quite an interesting read indeed.

Could you ask the guy at BTT, as he already has an "open channel", to ask them about projected patient availability in a follow up email? I tried asking via their facebook page but unfortunately got no response. I think this info is the most crucial for many people here, as it influences the decision whether to get a hair transplant or hold off till RepliCel's RCH-01 becomes available.

Do you think this is little bit disappointment?

 

[benjt]

I would call it mixed.

The good news: They have results published in a peer reviewed journal confirming immunoregulatory effects of DSC cells. This is highly interesting because in Androgenetic Alopecia/male pattern baldness, we have this pseudo-immune response (with PGD2 - you know the cascade). This hints at something inside the DSC being the missing link between DHT and PGD2, and research should continue looking there to find the root cause.
It also supports their theory that DSC cells from the back of the scalp could not only repopulate the target area with healthy hair follicles, but downright halt any Androgenetic Alopecia progression. In other words, RepliCel's RCH-01 is the cure as it stops further balding (once there are more DSC cells from the back of the scalp in the target area than original DSC cells). As it seems the number of injection sessions you will need for this effect will vary from person to person. But after this individual number of sessions is completed, your Androgenetic Alopecia is cured and you won't need refreshments.

The negative point though is that they haven't answered my questions about availability, which could mean they don't know and don't want to admit that. They did have some troubles with getting Phase 2b running. It was scheduled for Q4/2014 and still hasn't started. So I would really appreciate if you could relay my request to the guy at BTT that already had some correspondence with them to ask them too.

Bottom line: RepliCel's RCH-01 seems to be the cure, but as of now no info is publicly available regarding when you can get the treatment. Please someone else try asking them too. Best would be to have as many people as possible ask them to create some pressure, both via email and on their facebook page, and then post their replies here.

 

[dps]

I would call it mixed.

The good news: They have results published in a peer reviewed journal confirming immunoregulatory effects of DSC cells. This is highly interesting because in Androgenetic Alopecia/male pattern baldness, we have this pseudo-immune response (with PGD2 - you know the cascade). This hints at something inside the DSC being the missing link between DHT and PGD2, and research should continue looking there to find the root cause.
It also supports their theory that DSC cells from the back of the scalp could not only repopulate the target area with healthy hair follicles, but downright halt any Androgenetic Alopecia progression. In other words, RepliCel's RCH-01 is the cure as it stops further balding (once there are more DSC cells from the back of the scalp in the target area than original DSC cells). As it seems the number of injection sessions you will need for this effect will vary from person to person. But after this individual number of sessions is completed, your Androgenetic Alopecia is cured and you won't need refreshments.

The negative point though is that they haven't answered my questions about availability, which could mean they don't know and don't want to admit that. They did have some troubles with getting Phase 2b running. It was scheduled for Q4/2014 and still hasn't started. So I would really appreciate if you could relay my request to the guy at BTT that already had some correspondence with them to ask them too.

Bottom line: RepliCel's RCH-01 seems to be the cure, but as of now no info is publicly available regarding when you can get the treatment. Please someone else try asking them too. Best would be to have as many people as possible ask them to create some pressure, both via email and on their facebook page, and then post their replies here.

all good and fine, but halting progression in not cure.
full regrowth is cure.

 

[benjt]

As you apparently didn't read the rest of the thread, their treatment does both. In fact, the regrowth was confirmed and the halting of further balding was the news.

 

[BiqqieSmalls]

According to ClinicalTrials.gov, there is nothing regarding RepliCel's hair treatment. Can anyone shed some light on this? Am I looking in the wrong direction?

 

[hellouser]

According to ClinicalTrials.gov, there is nothing regarding RepliCel's hair treatment. Can anyone shed some light on this? Am I looking in the wrong direction?

You won't find Shiseido's clinical trial there, thats for sure. But Replicel's own trial is taking place in Germany I believe, not sure how that will affect the FDA approval process or having it show up on the Clinical Trials website.

 

[Joxy]

[h=2]The dermal cup, home to the elusive dermal stem cell[/h]
The scientific community has long sought to uncover the identity of a true dermal stem cell. While many unique cell populations have been described in the literature, some of which are predictive of a dermal stem cell, the exact location and behavior of this cell has largely eluded us. In a landmark paper published in December 2014, Dr. Jeff Biernaskie and his colleagues at the University of Calgary used a number of eloquent in vivo lineage tracing experiments to locate and track this cell over the course of single hair cycles and multiple consecutive hair cycles.

http://www.signalsblog.ca/the-dermal-cup-home-to-the-elusive-dermal-stem-cell/

 

[macbeth81]

According to ClinicalTrials.gov, there is nothing regarding RepliCel's hair treatment. Can anyone shed some light on this? Am I looking in the wrong direction?

They have not yet started Phase IIb trials. I would assume it will be listed on ClinicalTrials.gov, as their Phase I/IIa is listed. Their first trial is still ongoing but strictly for gathering longer term safety data hence ongoing status on the site. Their initial trial was listed under Trichoscience and not RepliCel. I would assume their new trials will be listed under RepliCel as they did for RCT-01.

https://clinicaltrials.gov/ct2/show/NCT01286649?term=trichoscience&rank=1

 

[Joxy]

Is this same just like Replicel?

http://theracell.eu/?page_id=2470

 

[hellouser]

Replicel has a new website:

http://www.replicel.com/