To keep you guys updated and move RepliCel back into focus, I wanted to create a new thread on them. Frankly, they are currently the only ones I consider remotely close to making an effective regrowth solution available. Also, within the last few months they published more and more details on their procedure. They seem to be sufficiently confident that competitors will not be able to catch up with them.
With a certain delay (as always in biotech), Phase 2 trials are finally starting in Q4 2014 (original plan was Q2 2014). The study design is quite well done. Two out of four groups will receive treatment, with the other two being purely placebo. The two treatment groups are: 1 single injection session (like in phase 1) but at different doses. This will reveal how much regrowth can be achieved and for how long, and how much one single injection can stabilize things.
As a side note: Their approach seems to give a "refresh" to the miniaturization process by replenishing DSC reservoirs. Miniaturization will continue, but is reset to a certain degree where follicles can produce hair again. A healthy follicle has around 500 DSC cells, most of which die off without being replaced during miniaturization. A completely miniaturized has 0 to 100 of these remaining. RepliCel's approach is to replenish these with externally replicated DSC cells. Each injection will refill a part of these DSC cells, restoring a part of the follicle's health.
The second of the two treatment groups will receive 90 (!) injections. And that is the interesting part. While we already knew from phase 1 that one injection with the dose used in P1 can lead to a density increase of up to 19% (one single injection!) and an average of 10-14% (depending on whether you factor in non-responders into the average), this will show whether multiple injections can gradually replenish the DSC cells even more than one injection. Optimally, until full recovery, i.e. around 500 DSC cells again. Full recovery of the DSC means, as it would seem, a completely healthy follicle again. I assume all of you know what this means.
Yes, the balding process would still continue - but you could just "refresh" your follicle's health every few years.
The next question is whether their approach is capable of repairing completely dead follilces or not. Phase 1 showed that there is a significant density increase, so the way I see it their injections have to work at least on partly miniaturized follicles. If they work on partly miniaturized and not on dead follicles, we could at least maintain what we have by resetting the miniaturization process of the follicles we still have every few years.
If they are in fact capable of reviving completely miniaturized follicles (i.e. from 0 DSC cells back to levels where follicles produce hair again), well, our problem would be solved for good (at least for those who can afford the treatment - and if they manage to get it, because if RepliCel works, the treatment sites will be overrun with waiting lists many months long). We don't know yet if a) subsequent injections are capable of gradually restoring the DSC cells of follicles with each application, and b) if that would also work for completely miniaturized follicles (which might have taken more damage than only the DSC due to fibrotic tissue). But that will be determined by the Phase 2 results, due to be released Q1 or Q2 2017. Yes, that is a long time, but the way I see things RepliCel is the only company this far.
So much for their approach and the trials, which will yield some certainty and do have some potential - at least for maintenance by repeated injections. And thats quite a perspective. If you can maintain your hair at an acceptable level (NW3/NW4) until you get their treatment, and you can fill up what cant be restored by RepliCels treatment from donor areas, you can keep an NW2 or NW3 for the rest of your life. No fear of going worse than that.
Now to the "success probability as perceived by stakeholders": As most of you know, RepliCel has partnered up with Shiseido. Shiseido provides both financing and a DSC replication facility to RepliCel in exchange for an exclusive distribution license in parts of ASEA (which is great for RepliCels financing and business process cause a cell replication facility is financially far out of their league, but sucks for us because Shiseido will likely become the bottleneck when treatment becomes available in ASEA). This clearly shows that Shiseido believes in RepliCels treatment yielding results which will grant earnings in excess of the millions that Shiseido is investing. In other words, they are confident in the results of RepliCel's approach. But this is old news. The new news is that RepliCel have joined a regenerative medicine consortium - which also has a cell reproduction site in North America at their disposal. This is good news, because apparently a second party is confident in RepliCels approach actually working. So now we have two independent instances, no doubt both with sufficient expertise in the area, believing that RepliCel will offer a treatment that many people will want to receive (and pay money for). Secondly, the Shiseido bottleneck may be partially resolved by a second facility. Thirdly, the location may hint at RepliCel preparing availability of their treatment in Northern America. However, unlike for the ASEAn countries Shiseido has a license for, we have no clue when it will be available. Due to biotech legislation, it might take significantly longer.
So much for the good news.
Now to the bad ones:
RepliCel has silently removed their time schedule for hair treatment availability in Shiseido's licensing area (Q1 2019 if I remember correctly). This might have to do with the 6 month delay for phase 2 trials (shifting things to Q3 2019), but it also might not. While it may be great that there is a treatment which seems to work (work as in: revive at least the partially miniaturized follicles and keep them stable by repeated injections), it sucks we do not know if it becomes available before it is too late for us. And even if their schedule only shifted from Q1 to Q3 2019, all of us know that schedules in biotech rarely work out, so it will likely take even longer.
The financial aspect might also suck. I have no idea how much cell cultivation costs in these scales. Costs for cultivation of cells of only one type in big bioreactors are quite low, but RepliCels approach requires a small bioreactor for each individual, driving costs up. Either way, I have no clue how much this will cost, but it will likely not be cheap. However, should phase 2 results hint at a "full cure", I'd be willing to spend many thousand dollars/euros on it.
Next thing is the logistics. Treatment will definitely be available first in some ASEAn countries, as far as I know Japan and China. It will only be provided by Shiseido, and cell replication will thus only happen in Shiseido's replication facilities. If the results of RepliCel's phase 1 trials are confirmed or even surpassed, there will be a huge demand for treatment which I doubt can be met by only one facility. Also, they need cooperating clinics and doctors, another potential bottleneck. This will likely lead to big waiting lists if their treatment is effective.
So all in all, it will likely be expensive, be earliest available in Q3 2019, and it is questionable whether you will get treatment right when its available. But the way I see things it can be used to reset the miniaturization process at least on partially miniaturized follicles, so you can re-stabilize matters with repeated injections and halt your balding process that way. The optimal outcome would be revival of completely miniaturized follicles through subsequent injections, with each injection replenishing the DSC cells more and more until they get close to their natural count of 500 per follicle again. If RepliCel's approach can do that, only time (or rather the phase 2 results with 90 injections) will tell. It may still take its time, but given the support of two independent expert third parties I am very optimistic about RepliCe's efficacy.
With a certain delay (as always in biotech), Phase 2 trials are finally starting in Q4 2014 (original plan was Q2 2014). The study design is quite well done. Two out of four groups will receive treatment, with the other two being purely placebo. The two treatment groups are: 1 single injection session (like in phase 1) but at different doses. This will reveal how much regrowth can be achieved and for how long, and how much one single injection can stabilize things.
As a side note: Their approach seems to give a "refresh" to the miniaturization process by replenishing DSC reservoirs. Miniaturization will continue, but is reset to a certain degree where follicles can produce hair again. A healthy follicle has around 500 DSC cells, most of which die off without being replaced during miniaturization. A completely miniaturized has 0 to 100 of these remaining. RepliCel's approach is to replenish these with externally replicated DSC cells. Each injection will refill a part of these DSC cells, restoring a part of the follicle's health.
The second of the two treatment groups will receive 90 (!) injections. And that is the interesting part. While we already knew from phase 1 that one injection with the dose used in P1 can lead to a density increase of up to 19% (one single injection!) and an average of 10-14% (depending on whether you factor in non-responders into the average), this will show whether multiple injections can gradually replenish the DSC cells even more than one injection. Optimally, until full recovery, i.e. around 500 DSC cells again. Full recovery of the DSC means, as it would seem, a completely healthy follicle again. I assume all of you know what this means.
Yes, the balding process would still continue - but you could just "refresh" your follicle's health every few years.
The next question is whether their approach is capable of repairing completely dead follilces or not. Phase 1 showed that there is a significant density increase, so the way I see it their injections have to work at least on partly miniaturized follicles. If they work on partly miniaturized and not on dead follicles, we could at least maintain what we have by resetting the miniaturization process of the follicles we still have every few years.
If they are in fact capable of reviving completely miniaturized follicles (i.e. from 0 DSC cells back to levels where follicles produce hair again), well, our problem would be solved for good (at least for those who can afford the treatment - and if they manage to get it, because if RepliCel works, the treatment sites will be overrun with waiting lists many months long). We don't know yet if a) subsequent injections are capable of gradually restoring the DSC cells of follicles with each application, and b) if that would also work for completely miniaturized follicles (which might have taken more damage than only the DSC due to fibrotic tissue). But that will be determined by the Phase 2 results, due to be released Q1 or Q2 2017. Yes, that is a long time, but the way I see things RepliCel is the only company this far.
So much for their approach and the trials, which will yield some certainty and do have some potential - at least for maintenance by repeated injections. And thats quite a perspective. If you can maintain your hair at an acceptable level (NW3/NW4) until you get their treatment, and you can fill up what cant be restored by RepliCels treatment from donor areas, you can keep an NW2 or NW3 for the rest of your life. No fear of going worse than that.
Now to the "success probability as perceived by stakeholders": As most of you know, RepliCel has partnered up with Shiseido. Shiseido provides both financing and a DSC replication facility to RepliCel in exchange for an exclusive distribution license in parts of ASEA (which is great for RepliCels financing and business process cause a cell replication facility is financially far out of their league, but sucks for us because Shiseido will likely become the bottleneck when treatment becomes available in ASEA). This clearly shows that Shiseido believes in RepliCels treatment yielding results which will grant earnings in excess of the millions that Shiseido is investing. In other words, they are confident in the results of RepliCel's approach. But this is old news. The new news is that RepliCel have joined a regenerative medicine consortium - which also has a cell reproduction site in North America at their disposal. This is good news, because apparently a second party is confident in RepliCels approach actually working. So now we have two independent instances, no doubt both with sufficient expertise in the area, believing that RepliCel will offer a treatment that many people will want to receive (and pay money for). Secondly, the Shiseido bottleneck may be partially resolved by a second facility. Thirdly, the location may hint at RepliCel preparing availability of their treatment in Northern America. However, unlike for the ASEAn countries Shiseido has a license for, we have no clue when it will be available. Due to biotech legislation, it might take significantly longer.
So much for the good news.
Now to the bad ones:
RepliCel has silently removed their time schedule for hair treatment availability in Shiseido's licensing area (Q1 2019 if I remember correctly). This might have to do with the 6 month delay for phase 2 trials (shifting things to Q3 2019), but it also might not. While it may be great that there is a treatment which seems to work (work as in: revive at least the partially miniaturized follicles and keep them stable by repeated injections), it sucks we do not know if it becomes available before it is too late for us. And even if their schedule only shifted from Q1 to Q3 2019, all of us know that schedules in biotech rarely work out, so it will likely take even longer.
The financial aspect might also suck. I have no idea how much cell cultivation costs in these scales. Costs for cultivation of cells of only one type in big bioreactors are quite low, but RepliCels approach requires a small bioreactor for each individual, driving costs up. Either way, I have no clue how much this will cost, but it will likely not be cheap. However, should phase 2 results hint at a "full cure", I'd be willing to spend many thousand dollars/euros on it.
Next thing is the logistics. Treatment will definitely be available first in some ASEAn countries, as far as I know Japan and China. It will only be provided by Shiseido, and cell replication will thus only happen in Shiseido's replication facilities. If the results of RepliCel's phase 1 trials are confirmed or even surpassed, there will be a huge demand for treatment which I doubt can be met by only one facility. Also, they need cooperating clinics and doctors, another potential bottleneck. This will likely lead to big waiting lists if their treatment is effective.
So all in all, it will likely be expensive, be earliest available in Q3 2019, and it is questionable whether you will get treatment right when its available. But the way I see things it can be used to reset the miniaturization process at least on partially miniaturized follicles, so you can re-stabilize matters with repeated injections and halt your balding process that way. The optimal outcome would be revival of completely miniaturized follicles through subsequent injections, with each injection replenishing the DSC cells more and more until they get close to their natural count of 500 per follicle again. If RepliCel's approach can do that, only time (or rather the phase 2 results with 90 injections) will tell. It may still take its time, but given the support of two independent expert third parties I am very optimistic about RepliCe's efficacy.
