Replicel Update - Oct. 22, 2014 Presentation

[macbeth81]

In Phase I they injection 5-10 million DSC cells and in the initial mice test it was 3-5 million. I don't know why the wide range in humans, because the difference is double the dosage. Maybe they will use dosages of 3, 5, and 10 million to dose down. I hope they release the details of their trials but probably not. I asked them specifically, in my private Facebook message, if they were using higher dosages. If not this treatment will not be very effective.

They did supposedly improved their culturing technique. The culturing is the most important part of their protocol, so hopefully that takes this to the next level. The one patent of Shiseido's regarding dermal sheath cells mentions culturing, but I don't understand the science to know if it is an improvement.

 

[Partways]

I'm a little confused, I thought replicel was suppose to regenerate most of the dead hair follicles but based on this presentation it'll only halt hairloss and maybe show a 20% increase in growth?

 

[benjt]

Wow. You are now, like, the 5th person to ask this question which has been answered before.

 

[brunobald]

Replicel should team up with the german group that are pioneering the hair on a chip program. To prove the science they need to isolated a follicle and prove that injected dermal cup sheath cells do indeed migrate and become part of the follicle.

 

[macbeth81]

Just posted the questions on RepliCel's facebook site. Let's see if we can get an answer.

Well they sure answered your question without making any commitments. Looks like it is on Shiseido to get it together and start their trials. I am still waiting on a response to my private message regarding whether higher dosages will be used in Phase II. Maybe I should have posted publicly too.

 

[hellouser]

RepliCel Until we have a treatment we cannot speculate on cost.

Well, they don't have a treatment for tendonosis, but David Hall bluntly fired off a price range of $3-5k.

 

[Joxy]

[h=2]R. Lee Buckler: How RepliCel Is Harnessing the Awesome Power of Cell Therapy[/h]
Regenerative medicine and cell therapies hold possibilities for achieving near miracles in a multitude of indications, from life-saving treatments to aesthetic applications. RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB) is tackling a mix of medical and cosmetic issues that include hair regeneration, repair of painful and debilitating tendon injuries and rejuvenation of damaged skin. In this interview with The Life Sciences Report, R. Lee Buckler, the company's new vice president of business and corporate development, discusses his firm's innovative technology platform and the upcoming milestones that could affect its shares.

http://www.thelifesciencesreport.co...e-power-of-cell-therapy#.VF0UXpagFiQ.facebook

 

[benjt]

Asked them for some specifics on their facebook page as a follow-up to my initial question. Let's see if we can get anything.

Also, as I said before: The more people ask and respond (likes, formulating questions of their own, etc), the bigger the pressure for them to actually provide some useful info.

 

[benjt]

macbeth, any reply to your inquiry?

 

[macbeth81]

macbeth, any reply to your inquiry?

Negative, no response.

I see that someone keeps trying to push for a answer to your question unsuccessfully.

 

[hellouser]

A rational question:


Hair transplants take up to around 1 year and longer sometimes for complete results. These are transplants of completely developed follicles that already grow terminal hairs.


Considering this, why do we expect greater results from Replicel in only 6 months from follicles that may not have (and probably havent) formed into complete, large, terminal hair growing follicles?


Shouldn't we be expecting more definitive results after 1 year rather than just 6 months?

 

[macbeth81]

They had a 2012 presentation which actually brought that point up. They explained that the trauma of the injection could have resulted in some of the patients being below base-line (shock-loss). They likened it to hair transplantation and how hairs fall out before returning 6-12 months later.

I have asked if they evaluated at 12 months, and they stated they did not. No such data was mentioned in the Shiseido collaboration agreement either. It is very odd they didn't bother to check, definitely considering that was part of the original Phase I/IIa trial design. I can only assume results were "good enough" and they wanted to spend the time instead on Phase IIb trials, which have unfortunately been delayed 2 years.

The reason for the delay was mentioned in the recent Buckler interview.

“The new media wasn't producing the same results, so we had to go back to the drawing board and discover what the problem was.â€￾

It is very troubling that their procedure can be taken "back to the drawing board" this deep in the process. Not to mentioned in 2013 they were stating they improved their culture method. I wonder if this was part of the resolution or afterwards.

Finally, they still have not answered if they will increase the dosage. In their 2012 presentation they stated Phase IIB will use a high, medium, low dosage and the Phase I/IIa dosage was described as high. Their "high" dosage was simply not enough. The only hope is that it is compoundable, but at this low yield you would need a lot of repeat injections. The cost of flying to/from Japan would be several thousand, then you have the cost of the procedure itself. Release in North America is a long ways off.

My faith on RepliCel is diminishing.

 

[hellouser]

Finally, they still have not answered if they will increase the dosage. In their 2012 presentation they stated Phase IIB will use a high, medium, low dosage and the Phase I/IIa dosage was described as high. Their "high" dosage was simply not enough. The only hope is that it is compoundable, but at this low yield you would need a lot of repeat injections. The cost of flying to/from Japan would be several thousand, then you have the cost of the procedure itself. Release in North America is a long ways off.

My faith on RepliCel is diminishing.

If Replicel and Histogen get a release within around the same time, I think it'd be best to book a flight to Japan and elsewhere, wherever Histogen's treatment is performed, and have both done... I'd go to Japan for Replicel first and then fly out for Histogen's growth factors days later....

This is wishful thinking though... it's been 20 years of the same old sh*t for hair loss treatment so obviously my expectations of this scenario are low.

 

[macbeth81]

Well on the bright side, if they keep spacing out the injections 3 months apart, by the time you are on your 8th+ injection you might be able to get it done domestically. Compounding at 20% will take awhile for full restoration, if you are one of the lucky best responders.

 

[macbeth81]

Well Replicel is responding to our questions, but not answering them...

They stated they will use a high, medium, and low dosage in Phase IIb, but relative to the Phase I/IIa they would not answer. Previously the Phase I/IIa dosage was described as high (by Mr. Hall and a 2012 presentation). Seems like a waste of time/money trying the same/lower dosage with such poor yield unless they believe a higher dose will not improve results. We are also approaching December and still trials have not started? Finally the Shiseido trials are "a while away"?

I would not expect them to answer on a release date, when they cannot answer regarding the near-term (dosages and trial start dates). Any estimate would also be useless because they cannot live up to their own time lines.

 

[hellouser]

Well Replicel is responding to our questions, but not answering them...

They stated they will use a high, medium, and low dosage in Phase IIb, but relative to the Phase I/IIa they would not answer. Previously the Phase I/IIa dosage was described as high (by Mr. Hall and a 2012 presentation). Seems like a waste of time/money trying the same/lower dosage with such poor yield unless they believe a higher dose will not improve results. We are also approaching December and still trials have not started? Finally the Shiseido trials are "a while away"?

I would not expect them to answer on a release date, when they cannot answer regarding the near-term (dosages and trial start dates). Any estimate would also be useless because they cannot live up to their own time lines.

Problem is this:

Their marketing/social media guys are completely ignorant of any real dates. Their only job is to regurgitate the same crap over and over again from what they heard once. They're not interested in specifics like we are... they often won't care to ask anyone higher up because they'll get paid to do the bare minimum. You want real answers? Ask David Hall.

 

[benjt]

macbeth, the statement that they'll go for lower doses is 2.5 years old. They ran into cultivation medium problems in the meantime so things have likely changed. Wouldn't make any guesses here. Also, as you've said before the cultivation medium and process are the major factors of success for their approach. A low dose with 90% functioning cells is better than a high dose with 30% function cells (of course, this is subject to specific amounts and concentrations - you get the idea). They stated in one of their releases in H2 of 2014 that they have greatly improved the cultivation process - so if we assume a worse DSC cell yield before during I/IIa, there likely was an increase in effectiveness so you'll repair more follicles with the same amount of agent.

I think they actually can give rough estimates. We know that phase IIb data will be available latest at the end of Q3 2016. They must have some road map for market phase (they need it for investors), and after the trials there are only few unknowns for the initial availability. The unknowns (bottlenecks through doctors/clinics, e.g.) only have an impact on how many people can be treated in the initial months/years after availability, but shouldn't affect the point in time of availiability.

 

[Fena2000]

I have a question for sufferers of diffuse unpatterned alopecia, which I think I belong to (I'm a woman btw). Will stem cell treatment be effective for this type of alopecia as well. DUPA means there is thinning all over the scalp, all the hairfollicles are affected by DHT.

 

[benjt]

As long as the underlying process (inflammation and apoptosis of DSC and DP cells) is the same, which it very likely is, then yes it will also work für DUPA.

 

[Fena2000]

As long as the underlying process (inflammation and apoptosis of DSC and DP cells) is the same, which it very likely is, then yes it will also work für DUPA.

Thank you ! I so hope you're right.