Shiseido Hair Loss Clinical Trial To Begin

[Swoop]

http://the-japan-news.com/news/article/0003046120

Clinical trial will be done on ~60 people consisting of both men and women.

Seems they are very close to beginning now. Good stuff.

 

[Xaser94]

If they are talking about in 3 years being able to get all ur lost hair back then this is great news. If they mean they will be able to only halt further hair loss in 3 years, then Im screwed lmao.

 

[thomps1523]

If they are talking about in 3 years being able to get all ur lost hair back then this is great news. If they mean they will be able to only halt further hair loss in 3 years, then Im screwed lmao.

Their goal has always been regrowth not just maintenance, so let's hope they hit the target that they're aiming for!

 

[Torin]

It looks optimistic but, if Replicel couldn't work miracles with rch-01 over nearly a decade, only managing efficacy, how should we expect Shiseido of being capable of doing any differently? I don't get that.

 

[pegasus2]

It's great that they are starting, but it sounds like at least 2020 before they go commercial. Why do they need a 3 year long trial? They must be including phase III in that, but does this mean regulators won't allow them to offer it after phase II? This article gives us more questions than answers.

Also, if it only works on hairs in the anagen phase how is it going to provide much regrowth? Beyond a certain point they stop entering anagen, don't they?

 

[GotHair?]

Yeah 3 year long trial. The regrowth should be pretty high in order for me to consider this by the time it comes.

 

[champpy]

I thought the point of doing this in Japan was that it could be available after phase 2? But geez a three year trial....wtf. Might as well just do a full 3 phase trial, We will still have to wait the same amount of time.

 

[Blackber]

Does no one read or look back at past threads??

If they can prove safety and efficacy in Japan they'd potentially be able to offer the treatment while Phase 2 is still ongoing hence the 2018-2019 dates being given.

 

[pegasus2]

Does no one read or look back at past threads??

If they can prove safety and efficacy in Japan they'd potentially be able to offer the treatment while Phase 2 is still ongoing hence the 2018-2019 dates being given.

Yes, everyone knows that. The key word is "potentially". The article makes it sound like that's not going to happen.

I wish they would go ahead and make this thing available in the Bahamas while they are conducting trials in the other countries. It would help them fund their trials.

 

[Blackber]

"Everyone" is asking for an answer that cannot exist until they progress with their Phase 2 trial.

 

[pegasus2]

"Everyone" is asking for an answer that cannot exist until they progress with their Phase 2 trial.

We can't know positively until after phase II is completed, and regulators give the ok. They may already know in the negative though if regulators already told them they will not allow it. That is what the article seems to suggest, and what I, for one, would like some clarification on.

 

[Pray The Bald Away]

Yes, everyone knows that. The key word is "potentially". The article makes it sound like that's not going to happen.

I wish they would go ahead and make this thing available in the Bahamas while they are conducting trials in the other countries. It would help them fund their trials.

2016+3=2019

 

[Knockin on nw4]

2016+3=2019

2016 is halfway over. Call it 2020

 

[pegasus2]

2016 is halfway over. Call it 2020

And they won't be going straight from trial to clinic. It takes time to commercialize.

 

[pegasus2]

I'm more surprised at the roughly 60 subject trial than the timeline. This is their make or break moment and we're relying on 60 people (and I assume only a percentage of them will get the real treatment)? Samumed had a good 300 or so I believe, though they were spread out over several clinics.

That struck me as well. I guess about 20 men, 20 female, and 20 placebo. This hardly seems like a definitive trial. I don't think it would be unusual if they weren't aiming for early commercialization under Japan's new laws. I would be surprised though if they could get approval to start administering the treatment after such a small trial. Just another thing that points to it not being available until after phase III.

 

[Joxy]

Maybe these are just pre-clinical trials with only 60 people? What gives me optimism is that university doctors will be also involve in clinical trials.

 

[Xaser94]

http://replicel.com/recent_coverage/shiseido-trial-baldness-cure-planned-commercial-launch-2018/

This was posted on Replicel's "recent coverage" under Media on their website.It was posted on March 23, 2016.

"Major cosmetics maker Shiseido Co. plans to grow into the baldness treatment market with a regenerative hair loss treatment to be launched in Japan and other Asian countries in 2018.

The company will start a clinical study this year to trial its hair growth revival method.

The method involves cutting off a section of the back of the scalp where hairs still grow. Researchers in medical institutions will remove a circle of the skin with a diameter of about 5 millimeters.

Then, at a laboratory exclusively used for the study, the researchers will extract from the skin the cells that are important for hair growth and artificially increase their numbers through cultivation.

The cultivated cells will be transplanted onto the bald areas of the scalp. This is expected to reactivate the tissues that support hair, leading to the revival of its growth.

The method involves cutting off a much smaller section of skin than is necessary in hair transplants. Furthermore, as the patient’s own cells are used, the risk of rejection that may occur after the cell transplantation will be small, Shiseido said.

The method can be used for both men and women, the company added.

Shiseido will confirm the safety and effects of its method in cooperation with medical doctors engaged in studies on hair, said company Vice President Tsunehiko Iwai.

In 2013, Shiseido entered an agreement on technological cooperation with RepliCel Life Sciences Inc., a Canadian company engaged in developing hair growth revival technologies.

In May 2014, Shiseido set up a facility in Kobe to cultivate and process cells. The following year the company obtained permission from the health ministry to process and manufacture cells.

Shiseido’s hair revival business will not be covered by the national health insurance program.

“The fee to receive the treatment will be at least 100,000 yen ($887),” Iwai said."


So maybe the three year trial will be just the full trial length but the product will be released in 2018. I hope there isnt any miscommunication going on. Maybe at Replicel's next big event one of our own can ask them to make sure.

 

[Desmond_84]

Hey guys,

This article clearly states the trials have NOT begun yet. The first sentence in the article clearly states:

A group of scientists from Tokyo Medical University, Shiseido Co. and others WILL start a clinical study this year

They are aiming at beginning the trial in 2016 but nothing is set in stone yet. I promise you as soon as the first patient gets signed up and gets the treatment, REPLICEL & Shiseido social media team will spam like no tomorrow.

Let's hope they do begin this year though, since it would make finasteride obsolete if it works as hypothesised.

Cheers.

 

[Roberto_72]

http://the-japan-news.com/news/article/0003046120

Clinical trial will be done on ~60 people consisting of both men and women.

Seems they are very close to beginning now. Good stuff.

The idea this could be in three years is fantastic.
Even though I think it could have been sooner if the method is already established.

I guess it really would take less than a year to understand if it works or not... Just like hair transplants today. Cut, (replicate), implant, wait for growth.

 

[pegasus2]

Hey guys,

This article clearly states the trials have NOT begun yet. The first sentence in the article clearly states:



They are aiming at beginning the trial in 2016 but nothing is set in stone yet. I promise you as soon as the first patient gets signed up and gets the treatment, REPLICEL & Shiseido social media team will spam like no tomorrow.

Let's hope they do begin this year though, since it would make finasteride obsolete if it works as hypothesised.

Cheers.

I hope you're right. I'm hoping for an eta on availability when they announce that trials have started. They haven't been shy about giving timelines in the past, so I'm hopeful we will know soon.