RepliCel - Spencer Kobren's Follow Up Interview With CEO David Hall

[NotBelievingIt]

Aren't You at least a bit worried about the safety ?

RepliCel has repeatedly stated that they are using an autologous technique.

au·tol·o·gous (ô-tl-gs)
adj.
Derived or transferred from the same individual's body: autologous blood donation; an autologous bone marrow transplant.

What this means is, there is no foreign chemical introduced into the body.

The cells are multiplied in a neutral solution that is basically a pH of 7, the body has no reaction to it - or rather, shouldn't

In other words, all they are doing is taking your cells, multiplying them and putting them back, albeit in a different location.

The thing with their Phase I trial is that it is both a safety and efficacy. It can't not be. So while they will report no concerns, they will also know safety and efficacy, so the second set of trials is basically just more of the same - just on a larger patient base.

Thats the beauty of autologous techniques. Its already known to be perfectly safe*, but the FDA stands for Fraking Dumb Ass and won't acknowledge autologous separately then a chemical based drug trial.

I'm concerned that it might not be effective for slick bald men...can they really reactivate those follicles? or will it only work for minituarized hairs...which Dr. Rolf hoffman suggested in an interview i've read somewhere.

I know they only recruit norwood 3 n 4 in the trial so thats not good news. I don't think I will have any hair left when the "SAVING" is here.

Slick Bald men are likely to see significantly less, or slower, growth in my opinion. It would depend entirely upon just how dormant the folliciles are. Did they really just stop growing, or is their growth phase so shortened that they barely/never breach the surface? The hair needs strength to push through the skin, so if it lacks that strength, the DSC might just provide the backbone needed. If the DSC really does shield the follicile it should in theory return to normal growth cycles. Growth stimulants like Minoxidil or other topicals/orals might need to be taken to speed the process up though, but once the growth has taken hold at acceptable levels, the treatment could be stopped because it would not be needed to maintain the growth.

Its fun to theorize! But also depressing to imagine it not working like that

One concern that should be noted with being totally bald is that the growth would potentially be spotty for quite some time and might look terrible. Spotty growth when there already is hair would be tolerable though, IMO.

[Maradona]

Uh, no. Just no.

Phase I trials do not demonstrate a product to be safe; they are performed on small groups to identify any obvious health concerns before moving on to the next phase of testing. Safety issues may still be uncovered in later phases of testing as the sizes of the sample groups increase (as demonstrated by a number of products that have been recalled for safety issues even after finishing clinical trials and reaching the market).

I wouldn't wait a second if it comes out or if they take me for the trial(i'd move to georgia, canada).

I'm concerned that it might not be effective for slick bald men...can they really reactivate those follicles? or will it only work for minituarized hairs...which Dr. Rolf hoffman suggested in an interview i've read somewhere.

I know they only recruit norwood 3 n 4 in the trial so thats not good news. I don't think I will have any hair left when the "SAVING" is here.


Sighs.....if only propecia didn't give me side effects...i wouldn't even be here.

[gmonasco]

god damnit they already did a study where they checked treatment's safety! It turned out to be safe.

Uh, no. Just no.

Phase I trials do not demonstrate a product to be safe; they are performed on small groups to identify any obvious health concerns before moving on to the next phase of testing. Safety issues may still be uncovered in later phases of testing as the sizes of the sample groups increase (as demonstrated by a number of products that have been recalled for safety issues even after finishing clinical trials and reaching the market).

[jpm]

death before baldness

haha! well its for the good for all of us that some people are willing to take the minimal risk. If no human participated in trials, medicine wouldn't be where it is today

and stredssedtothebald do you stay in on windy days for fear of being blown over or rainy days for fear of drowning in a puddle. You always see the worst possible outcome for everything!!! I think pessimism and over worrying is your biggest problem not baldness

[ccmethinning]

Aren't You at least a bit worried about the safety ?

death before baldness

[greatjob!]

most likely not anywhere in the first world countries ....

I think the trials going on now are in the country of Georgia, I would think that to up the participant numbers they would expand the number of sites as well, just curious.

[2020]

What are the requirements for participants? Do you have to be off propecia and rogaine? Also do you know in what cities the trials will be conducted?

most likely not anywhere in the first world countries ....

[greatjob!]

They're already recruiting and I've signed up! Finding 3000 men shouldn't be difficult if the results of phase 1 are decent.

What are the requirements for participants? Do you have to be off propecia and rogaine? Also do you know in what cities the trials will be conducted?

[2020]

Aren't You at least a bit worried about the safety ?

god damnit they already did a study where they checked treatment's safety! It turned out to be safe. Get over it

[StressedToTheBald]

They're already recruiting and I've signed up! Finding 3000 men shouldn't be difficult if the results of phase 1 are decent.

Aren't You at least a bit worried about the safety ?

[chrisis]

They're already recruiting and I've signed up! Finding 3000 men shouldn't be difficult if the results of phase 1 are decent.

[Kiwi]

Phase 4 and 5 is after it's released. Not really a concern for us desperate balding types.

Also, I don't see why they couldn't run two Phase 3 trials simultaneously if they were excited about it and wanted it on the market quickly.

Thats a good point re phase 3 trials.

I am a bit nervous though. If it takes aderans around 11 months to sign up 100 people then imagine how long it'll take to secure 3000!!

[chrisis]

Phase 4 and 5 is after it's released. Not really a concern for us desperate balding types.

Also, I don't see why they couldn't run two Phase 3 trials simultaneously if they were excited about it and wanted it on the market quickly.

[Kiwi]

They might have to do phase 3 twice!

And did anyone even know about phase 4 and 5

http://en.m.wikipedia.org/wiki/Phases_of_clinical_research

[Follicle Death Row]

Not necessarily... but I of course hope so.

Yeah the wheels would already have to be in motion anyway to be ready for phase 2 if phase 1 comes up trumps. I'd say they're collecting the data now and may well have some idea already, perhaps even just anecdotally from some in the trial. However Aderans weren't hugely successful in phase 1 but proved the concept so hopefully Replicel are a notch above that. Here's hoping.