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RepliCel hair regeneration - 5 yr safety data + 2 yr efficacy data


#1

A press release from RepliCel today for its cell based hair regeneration product for the treatment of male and female pattern baldness or androgenetic alopecia.

Since RepliCel has confirmed that they will attend Dr. Mwamba’s @My_WHTC_Clinic_Repre IHRP Hair Conference in Vancouver, Apr 2017, I suspect all this will also be presented and discussed at the conference.

According to today’s press release, 5 year trial data confirms safety profile for RepliCel’s high-dose dermal sheath cup cells (DSCC) treatment for hair loss. No serious side effects were reported during the entire long term study that lasted over 60 months.

Results for the injection site biopsies will also be released in the next several weeks, just in time for IHRP Hair Conference in Vancouver.

Efficacy data collected for the 19 trial patients over a 2 year period confirms the following:

The seven top-tier responders in the trial saw >10% increase in hair density at six months post-injection… At 24 months, the average hair density increase for these same seven participants was 8.3% over baseline, and three of these seven trial participants maintained a >10% increase in density over baseline. The largest increase in hair density over baseline observed in this group was a 21% increase at 24 months.

The top 10 participants reported at least a 5% or greater increase in hair density at six months post-injection with an average increase of 11.8%. This group demonstrated a sustained response at 24 months which averaged a 4.2% increase over baseline hair density.

The entire press release can be found here


#2

This is a result of their phase 1 trial. Does anyone know if they’ve started their phase 2 trials?

A >10% increase of hair density does not sound impressive. What does this mean when there is zero hair in the region?

I’m willing to consider that this was only a phase 1 trial. I’m wondering if they limited the treatment due to the fact that they were only studying the safety aspects first. I have to also wonder if they will continue to improve the technique or if the treatment can be repeated to achieve better results.


#3

Phenomenally disappointing.


#4

For bald people hair density should increase 10000% to have a cosmetic effect.

Let’s hope that Ray Kurzweil is correct and those of us leaving 20 more years will live hundreds of years so when in 50 years time baldness is cured we can have our hair back in our 100s.


#5

As far as I know, they have not started phase 2.


#6

Only 19 trial patients? how could they draw any conclusions out of 19 test subjects?


#7

It sounds like the press release was put out to make it sound like they had completed a milestone (i.e. the “completion” of a five-year clinical study.) This gives the misleading impression they have momentum. Really, five years have passed since that phase I study and they haven’t even started phase II trials. I don’t recall them saying, at the time of the phase I study, that they’d wait 5 years to monitor the safety results from phase I before they move on to phase II. Does anyone recall them saying that?


#8

I did not expect anything better than this from Replicel. In fact, this is the data that we read 3 years ago. I’m wondering, what were Replicel doing for the last 5 years? Apart from having done injections 5 years ago???
So, they waited 5 years to confirm what they already knew 3 years ago.
I think, lack of results might explain why they haven’t found investors in the last 3 years to start phase2.


#9

It should be noted that at 6-months 30% of the patents had a significant amount of hair loss and Replicel’s recent info release (24-month data) does not clarify the situation with those 6-month non-responders.


#10

If Replicel can truly arrest hair loss that would be a breakthrough but I’m not convinced that Replicel can arrest hair loss.


#11

Roger, here’s a link to a story that goes back to 2013. It’s talks about the Replicel study results at the 6-month mark. Note that the story says some subjects lost hair at the 6-month mark. I can’t find the actual study anymore but I have seen it on the internet.

I do remember that the 6-month study indicated 30% of the test subjects lost hair at the 6-month mark. That’s a pretty significant number of non-responders among the test subjects. Now in 2017 Replicel is saying that at the 24-month mark all treated subjects stabilized their hair loss. But they don’t clear up what became of the 30% that lost hair at the 6-month mark. Here’s the 2013 story.

http://www.regrowhair.com/non-surgical-hair-loss-treatments/breaking-news-replicel-releases-hair-cloning-trial-updates/


#12

Why would a large company such as Shiseido invest in a technology that has only been tested on 19 people and with an average density increase of only 8.3% for the top tier responders?


#13

Why would you direct your question at Hairsite posters, instead of Shiseido?


#14

I was thinking the very intelligent posters here (such as yourself) may have an explanation for that.


#15

@jarjarbinx I know, which is all further evidence that Replicel is probably not something to get excited about…


#16

Roger, it would be great if Replicel will arrest hair loss and it comes to market, but those 6-month non-responders really bug me. I can’t reconcile them. I don’t know what became of them. I don’t even know if they factor into the 24-month data. Do you have any specific thoughts on this issue?


#17

Sure, but I don’t think they’re pitching this thing as something that will just “arrest” hair loss. If that’s the pitch, I think they’d get even less attention from investors than they seem to be getting now, which doesn’t seem to be a lot…


#18

Good point. I don’t think investors are WOWED! about arresting hair loss. Investors want good regrowth. If Replicel can arrest hair loss it would probably do well in the market but it’s doubtful it would get into the market because investment could dry up. But Shiseido is something of a wild card because they own the Japanese rights to Replicel and they might put it on the market in Japan even if all it does is arrest hair loss.