Replicel Hair Loss Treatment Trial Is Set To Begin In Japan

[hilbert]

People doubt RepliCel because the results of their phase I trial were underwhelming, to put it lightly, and they only followed progress for six months. I can't find anything about 5 years anywhere.

It's going to take some damn impressive results, with plenty of follow up, from phase II for me to regain confidence in RepliCel.

The smart money's on Tsuji and the funky bunch at this point.

imho we're comparing apples and bananas here.

Afaik, Replicel is mostly for maintenance (like current meds -- hopefully better and with no sides), Tsuji is for regrowth (like current transplants).
The one does not exclude the other, and both the market and individuals need both (e.g. you can tsuji your bald spots, but will still lose native hair if you don't replicel it).
It depends very much on where you're sitting: something to save still? Reached the bottom of it?

For the same reason, I'm not expecting stellar results from Replicel pics: maintenance is not spectacular.
But: if treating an area of my scalp with replicel means saving that hair for good, or for a long time... well, that's spectacular to me.

 

[nameless]

imho we're comparing apples and bananas here.

Afaik, Replicel is mostly for maintenance (like current meds -- hopefully better and with no sides), Tsuji is for regrowth (like current transplants).
The one does not exclude the other, and both the market and individuals need both (e.g. you can tsuji your bald spots, but will still lose native hair if you don't replicel it).
It depends very much on where you're sitting: something to save still? Reached the bottom of it?

For the same reason, I'm not expecting stellar results from Replicel pics: maintenance is not spectacular.
But: if treating an area of my scalp with replicel means saving that hair for good, or for a long time... well, that's spectacular to me.

I shrug when replicel talks about their treatment arresting losses.

 

[That Guy]

imho we're comparing apples and bananas here.

Afaik, Replicel is mostly for maintenance (like current meds -- hopefully better and with no sides), Tsuji is for regrowth (like current transplants).
The one does not exclude the other, and both the market and individuals need both (e.g. you can tsuji your bald spots, but will still lose native hair if you don't replicel it).
It depends very much on where you're sitting: something to save still? Reached the bottom of it?

For the same reason, I'm not expecting stellar results from Replicel pics: maintenance is not spectacular.
But: if treating an area of my scalp with replicel means saving that hair for good, or for a long time... well, that's spectacular to me.

Oh, don't get me wrong - I hope both work out. I fully intend to RepliCel and the Tsuji the sh*t outta my skull.

It's just that, if push comes to shove and I have settle with only one - Tsuji it is. I know this won't happen, but I can hope - since the RepliCel trials are taking place within a mile from Riken's labs or whatever, I really think it would be great if they would team up. Shiseido/RepliCel + Riken/Kyocera/Organ would be the hairloss supergroup to end them all.

 

[hilbert]

Oh, don't get me wrong - I hope both work out. I fully intend to RepliCel and the Tsuji the sh*t outta my skull.

It's just that, if push comes to shove and I have settle with only one - Tsuji it is. I know this won't happen, but I can hope - since the RepliCel trials are taking place within a mile from Riken's labs or whatever, I really think it would be great if they would team up. Shiseido/RepliCel + Riken/Kyocera/Organ would be the hairloss supergroup to end them all.

I'd be very worried if they team up, due to shared financial risk group. To be true, I'm also worried that the labs are just within 1 mile away.
Never group risks... e.g. what if an earthquake hit the area?
Never put all your eggs in a basket.

The market needs both, replicel and tsuji. I need both, since I have to improve bald areas and save existing hair.
Of course, if I had to choose one: Tsuji. At least I know I can regain after losing.

 

[hilbert]

I shrug when replicel talks about their treatment arresting losses.

omg, are there records of patients getting worse after the treatment?

 

[mr_robot]

omg, are there records of patients getting worse after the treatment?

Sure, the worst case was a 6% drop. They attributed it to shock loss from the injections.

 

[hilbert]

Sure, the worst case was a 6% drop. They attributed it to shock loss from the injections.

shock loss is a short term issue, when not permanent. how were these results after weeks or months?

 

[nameless]

Sure, the worst case was a 6% drop. They attributed it to shock loss from the injections.

Funny.

When different research groups testing *other* hair loss treatments have test subjects who lose hair they call those test subjects nonresponders. How come Replicel calls it "shock loss" when their test subjects lose hair?
Do they not know how to spell "nonresponder"?

If all hair loss research groups labeled their nonresponders "shock loss" cases instead of nonresponders then there would be NO failed treatments. Give me a break!

Replicel is looking like an outright fraud.

 

[nameless]

Sure, the worst case was a 6% drop. They attributed it to shock loss from the injections.

And of course they do NOT want to report hair loss so the actual losses may be worse than the reported losses.

 

[hellouser]

And of course they do NOT want to report hair loss so the actual losses may be worse than the reported losses.

Wouldn't they HAVE to report all the cases?

 

[nameless]

Wouldn't they HAVE to report all the cases?

They're supposed to. And they're also supposed to report the exact amount of losses for each test subject.

But numerous researchers have reported misinformation and even out-and-out lies to the FDA in the past. Researchers have been fined for that in the past. That doesn't mean that Replicel specifically is lying or reporting misinformation but don't lose sight of the fact that misrepresentation to the FDA does happen.

https://www.propublica.org/article/fda-let-drugs-approved-on-fraudulent-research-stay-on-the-market

 

[hilbert]

They're supposed to. And they're also supposed to report the exact amount of losses for each test subject.

But numerous researchers have reported misinformation and even out-and-out lies to the FDA in the past. Researchers have been fined for that in the past. That doesn't mean that Replicel specifically is lying or reporting misinformation but don't lose sight of the fact that misrepresentation to the FDA does happen.

https://www.propublica.org/article/fda-let-drugs-approved-on-fraudulent-research-stay-on-the-market

wait a sec, overspeculation warning here:
who used the term shock loss?
at what timepoint did those patient get 6pc worse?
where is the evidence that some cases were hidden?

 

[nameless]

They also claim they don't have efficacy data over 6 months post treatment, so either they legitimately don't have it (whether by choice or as a limitation of phase I trial), or it's just as underwhelming as their initial phase I reports. How have they tracked safety for 5 years - is it just self-report?

wait a sec, overspeculation warning here:
who used the term shock loss?
at what timepoint did those patient get 6pc worse?
where is the evidence that some cases were hidden?

A consumer doesn't need evidence (at this stage) that a specific research group has hidden some instances of nonresponse. A consumer just needs to know that it is not impossible that a specific research group could do that.

Then you look at them calling it "shock loss" when their test subjects lose hair and that looks fishy.

So you have them doing some fishy reporting (calling their nonresponders shock loss cases) + you know it's possible that any research group could report misinformation = be skeptical.

 

[Blackber]

I was just curious where those claims of 5 year safety data came from, and why Shiseido could continue tracking that (I don't think they did) but not efficacy.

I believe Dr. Hoffman mentioned the 5 year safety data in a recent interview posted on YouTube (might even be linked in this thread).

 

[Blackber]

I don't know why all the hate/hesitation and confusion over Replicel. Replicels method is sound from a medical standpoint and yes it will regrow hair as long as the follicle isn't completely gone. So if you have miniaturized hair/follicles it could very well restore those. From a practical standpoint that equates to regrowth in a vast number of cases. Replicel gives dht immunity to follicles. Tsuji gives you new (presumably dht immune) follicles.

As far as trial results, why don't you wait until they share those rather than make uneducated assumptions and drive people into hysteria because you think their method isn't sound. Last I checked none of you were scientists working in regeneration medicine.

Well said, especially the last part.

 

[hilbert]

A consumer doesn't need evidence (at this stage) that a specific research group has hidden some instances of nonresponse. A consumer just needs to know that it is not impossible that a specific research group could do that.

Then you look at them calling it "shock loss" when their test subjects lose hair and that looks fishy.

So you have them doing some fishy reporting (calling their nonresponders shock loss cases) + you know it's possible that any research group could report misinformation = be skeptical.

ok, you're just supposing with no specific supporting arguments.
i thought you knew about some negative results from replicel i wasn't aware of. phew

 

[nameless]

ok, you're just supposing with no specific supporting arguments.
i thought you knew about some negative results from replicel i wasn't aware of. phew

I don't know I would use the word "supposing" because I'm not just saying that some researchers have presented misinformation and lies, I'm also saying that Replicel researchers have already said something fishy. They are blaming the hair loss of some of their test subjects on "shock loss" which sounds fishy. Plus I'm also aware that they got poor hair growth results in their first study. You can find those study results on the internet if you care to look for them.

 

[hilbert]

ok,

I don't know I would use the word "supposing" because I'm not just saying that some researchers have presented misinformation and lies, I'm also saying that Replicel researchers have already said something fishy. They are blaming the hair loss of some of their test subjects on "shock loss" which sounds fishy. Plus I'm also aware that they got poor hair growth results in their first study. You can find those study results on the internet if you care to look for them.

ok, interesting. can you point me to the shock loss thing?
poor growth i dont care, since for me the goal and purpose of replicel is different.

 

[Greybeer]

Does Japan not have the new and innovative stem cell laws, to help promote researchers to work harder with them. These laws hold many different stipulations and benefits, but I think I remember and correct me if I'm wrong that in Japan after a phase 2trial is completed, they can basically offer their product!?

 

[jc3303]

Does Japan not have the new and innovative stem cell laws, to help promote researchers to work harder with them. These laws hold many different stipulations and benefits, but I think I remember and correct me if I'm wrong that in Japan after a phase 2trial is completed, they can basically offer their product!?

They can offer their product during phase II if they can prove safety and efficacy, but they must continue trials until final approval. That's why replicel is saying they may be able to offer treatment in 2018