Human ESC-Derived Hair Inducing Cells for Hair Regeneration

[Hairismylife]

That was the results at 6 months, which is absolutely meaningless. I'm sorry, but you're opinion is essentially based off nothing. Also, what one user reports on his experimental trial with bim doesn't mean much.

And I have to say again, if Bim will cause eye swelling in every patient using it for hairloss, it won't even be tested for hairloss. A bald man will a normal eye and a full head man will two eyes swelling like shit make no difference in appearance.

[sdsurfin]

And I have to say again, if Bim will cause eye swelling in every patient using it for hairloss, it won't even be tested for hairloss. A bald man will a normal eye and a full head man will two eyes swelling like shit make no difference in appearance.

just google bimatoprost and eye swelling. I'm not saying everyone will get that side effect, but a lot probably will, and I tend to get all almost all possible sides with drugs. Not a hypochondriac either, just sensitive.

As far as replicel is concerned, no they did not use a conservative dose in phase I. They used a very high dose, as is usual in safety trials. The phase II dose is lower. I'm not sure why people on this forum can't understand that, though I partly blame the CEO for constantly saying that the dosing is going to make a difference. Also, they are not testing many injections, just one on day one followed by a second at 90 days. I don't know where people are getting the info that their cell process has changed, I've never seen that written anywhere. My opinion is just an opinion, but it is a calculated one based on what I've read from the trials. It would greatly surprise me if the results improved very much with a second injection (maybe another 5%??) or even if it doubled the efficacy it would only be around 30 percent. still far from a cure, but i'd be happy if they marketed it for halting loss. Anything that is not a drug would be great. Another clue is the study done separately from replicel. essentially these scientists say that the building blocks are there, but they are not saying what replicel is doing is a cure. I think everyone knows that these cell therapies are the beginning of a cure, but replicel's process is definitely still the model T era. if it was a cure then it would have rocked in phase I.

I also just don't believe the timelines, replicel said they were starting phase II in 2013 and it got stalled until now, and i don't see them moving forward right now either. They seem to be much more focused on tendinosis (which is yielding much more convincing results). I'll probably have some hair on my head until I'm 40 judging by my family, which is 7 years from now, so hopefully by then there will be at least an OK maintenance option. I'd say we're looking at far longer for a real cure, so anyone that's already pretty bald is probably screwed, might as well live and be happy without good hair.

[sdsurfin]

"Our hair loss trial was delayed due to additional cell stability studies required for our Investigational Medical Product Dossier. We anticipate filing our submission for the phase 2 clinical trial late-2014. It’s important to note that our licensing partner for RCH-01, Shiseido Company, opened a purpose built facility to advance their planned clinical trials using our technology. This means that there will be two trials running parallel (one in Germany and one in Japan). This will give us twice as much data. The goal of a phase 2 trial is to determine what the ideal dosage is to get the best results."

It was not delayed because they were improving anything, it was delayed because they had to pass more safety hurdles. I'm pretty positive their process is still the same, and thus I don't know why anyone expects the results to be different. My guess, from a scientific perspective, is that the DSC cells are probably not enough to offset all the other androgen sensitive cells in the balding scalp. The other issue is that DP cells in balding scalp are different from non balding DP cells, so even if DSC cells are able to regulate the number of DP cells, they are working with flawed material basically. I think that when scientists are able to create solid combinations of non sensitive DP, DSC, and adipose cells, then we will be on the right track. Teams are working on this, and I'm happy for our children's generation, because I highly doubt they will have such limited options as we do. It blows being the last generation to have to go bald, but such is life.

[The Alchemist]

just google bimatoprost and eye swelling. I'm not saying everyone will get that side effect, but a lot probably will, and I tend to get all almost all possible sides with drugs. Not a hypochondriac either, just sensitive.

As far as replicel is concerned, no they did not use a conservative dose in phase I. They used a very high dose, as is usual in safety trials. The phase II dose is lower. I'm not sure why people on this forum can't understand that, though I partly blame the CEO for constantly saying that the dosing is going to make a difference. Also, they are not testing many injections, just one on day one followed by a second at 90 days. I don't know where people are getting the info that their cell process has changed, I've never seen that written anywhere. My opinion is just an opinion, but it is a calculated one based on what I've read from the trials. It would greatly surprise me if the results improved very much with a second injection (maybe another 5%??) or even if it doubled the efficacy it would only be around 30 percent. still far from a cure, but i'd be happy if they marketed it for halting loss. Anything that is not a drug would be great. Another clue is the study done separately from replicel. essentially these scientists say that the building blocks are there, but they are not saying what replicel is doing is a cure. I think everyone knows that these cell therapies are the beginning of a cure, but replicel's process is definitely still the model T era. if it was a cure then it would have rocked in phase I.

I also just don't believe the timelines, replicel said they were starting phase II in 2013 and it got stalled until now, and i don't see them moving forward right now either. They seem to be much more focused on tendinosis (which is yielding much more convincing results). I'll probably have some hair on my head until I'm 40 judging by my family, which is 7 years from now, so hopefully by then there will be at least an OK maintenance option. I'd say we're looking at far longer for a real cure, so anyone that's already pretty bald is probably screwed, might as well live and be happy without good hair.

Here is where it is written, from : http://www.thelifesciencesreport.com...f-cell-therapy

RLB: The fact of the matter is the company was delayed in progressing to its Phase 2 trial for RCH-01 in hair regeneration because of an issue with the supply of a critical growth media. 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. The comparability data is now coming in to support our belief that we've solved that problem. We have four trials expected to launch in the next few months (three of ours and one of Shiseido's). Two of these are expected to give clinical readouts late next year. Until we are a company executing clinical trials, we are a company talking about executing clinical trials, and certain investors grow understandably impatient.

[RGPHILPA]

Here ya go sport...

http://www.thelifesciencesreport.com/pub/na/r-lee-buckler-how-replicel-is-harnessing-the-awesome-power-of-cell-therapy

RLB: The fact of the matter is the company was delayed in progressing to its Phase 2 trial for RCH-01 in hair regeneration because of an issue with the supply of a critical growth media. 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. The comparability data is now coming in to support our belief that we've solved that problem. We have four trials expected to launch in the next few months (three of ours and one of Shiseido's). Two of these are expected to give clinical readouts late next year. Until we are a company executing clinical trials, we are a company talking about executing clinical trials, and certain investors grow understandably impatient.

[macbeth81]

RepliCel have never been specific regarding their Phase II doses, just using general high, medium, low which is a bit annoying. As a publicly trade company they should really explain their goal for using lower doses. Intuitively one would think lower dosage will yield less results.

I suppose their are three possible reasons to use lower doses. 1.) If the yield tapers off similar to Propecia, then they are optimizing the dosage. 2.) If the DSC cells degrade during multiplication, then a lower dosage could provide better yield. The cells would be less "water downed" and of better quality/potency. 3.) If for no other reason, then it is to burn money (pay staff, etc). Considering they have little to burn, they will fold quickly if this is their goal.

[brocktherock]

Read the thread that talks about it, it's real. and according to the published paper that is linked, this side effect happens in pretty much every bimatoprost user. its not pretty. theres a possibility it might not happen if not used on the eyelid, but the person who was talking about it on that thread experienced it and was using it only on his hairline, and at a much lower concentration.
bottom line is any drug is going to have unwanted sides. some people seem to be almost immune to nearly all side effects, but I'm not one of them.

as far as replicel is concerned, i know their first trial results very well. they had an average of 11 percent increase after 6 months. that is absolutely nothing cosmetically. their dosage in the phase I trial was a maximum safety dosage, you can find that in their own literature. If they already used a max dose, results are not gonna be better this time around. its comma sense. I contacted replicel about this (they had answered my previous queries), and they did not respond back. My guess is Hall is trying to keep this alive at all costs, and is concentrating on the dosage issue to distract from their piss poor results in phase I. If this ever does get released theres no way its a cure. best case scenario its good for maintenance, though something tells me you'd have to keep getting it every so often.

Can you post a link saying that was the max safety dosage? I don't see how they would know that without testing in humans. Also 11% is about where fin is at one year if you are a decent responder. Either way this will be better than fin.

[Justinian]

just google bimatoprost and eye swelling. I'm not saying everyone will get that side effect, but a lot probably will, and I tend to get all almost all possible sides with drugs. Not a hypochondriac either, just sensitive.

I just googled and can't find anything other than it being listed as a possible side effect. I did find this though "Last year, U.S. Marshals seized 12,682 applicator tubes ($2 million worth) of another product, Age Intervention Eyelash, which the FDA said contained bimatoprost that caused swelling of the eyes in some users. (Swelling isn’t listed as a side effect of Latisse, which contains a smaller amount of bimatoprost than Lumigan and isn't placed directly into the eye)." http://www.scientificamerican.com/bl...dru-2008-12-29

It's not like eyelid swelling is that uncommon... I've had it a few times over the years related to contacts lenses.

[Kudu]

Lumigan was approved for glaucoma, even though it is a low concentration of bimatoprost, I believe there would be more cases of eye swelling. If it was a major issue I don't think it would have been approved. It's even approved for eyelash growth I think this won't be a problem personally. I'm sure it has caused swelling, but I find it interesting that someone rubs it on their head and reports negative eye side effects that have only been reported because it is a drug used for the eye. Placebo effect?

[Justinian]

Lumigan was approved for glaucoma, even though it is a low concentration of bimatoprost, I believe there would be more cases of eye swelling. If it was a major issue I don't think it would have been approved. It's even approved for eyelash growth I think this won't be a problem personally. I'm sure it has caused swelling, but I find it interesting that someone rubs it on their head and reports negative eye side effects that have only been reported because it is a drug used for the eye. Placebo effect?

I don't think something like eyelid swelling could be placebo effect. But it could be hygiene related, if you rub your eyes after applying it, or rub your head and then put contacts in, etc...