Hair Loss Clinical Research Pipeline Released

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inham123

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http://hairclone.me/faqs/

WHEN WILL HAIR CLONING BE AVAILABLE
A.

This is the question that we are asked most frequently and it is very difficult to answer. To try to answer it, we have broken down what we need to do below and we will provide a more detailed explanation of this process as we develop the website.

Firstly, HairClone will need to research the optimum ways to multiply follicle cells in culture while still maintaining their activity and also the best way to return these cells to the scalp. The speed at which we can do this scientific parts of the research will depend on the amount of financial support that we receive through our various initiatives (see funding section). The clinical aspects will depend on getting permissions from the various UK regulatory agencies and we are hoping that we can begin clinical experience on a small scale in the UK, in the second half of 2017. At the same time, we can begin to cryopreserve and bank patients’ follicles. The revenue from this will be used to further support the research and clinical development and the patients who have banked follicles will have priority in regards to having treatments made available when we are ready to do so.

We hope that we can begin clinical trials proper within 3-5 years. It will take time to complete these trials and then apply for and obtain marketing licences from the regulatory bodies before this becomes a routine clinical treatment around the world. The management of HairClone, when in previous positions, have carried out over 19 different clinical trials around the world and have developed a variety of cell therapies that have treated around a million people so we have a huge amount of experience in this area. We will do our utmost with the financial resources that we have to develop this therapy as quickly and efficiently as possible, but we will carry out each step ethically, with patient safety our top priority. Please keep checking the website and follow us on Facebook (#HairClone) and Twitter (@HairClone) to keep updated on our progress.
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inham123 said:
Do we have any info on Rapunzel, what Angelo Christiano (and maybe Colin Jahoda?) are working on? I know a large clinical study involving hair cloning that Jahoda was running ended last month.

HairClone was started by the creator of Intercytex and has Dr Claire Higgins working with them. Do we have any updated info on them?

And what about that French team working on creating follicles for L'Oreal Paris?
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1) No, but that should be interesting.

2) Kinda answered your own question, but either way, it's going to be a long time before they go to market.

3) Back in the fall, when the plan was announced, they said they don't expect to be able to successfully print a follicle for at least 3 years yet. So it will be years before you hear from them.

Also, if anyone has been following Alexey Terskikh of Sanford-Burnham's Twitter and the Hairloss Cure 2020 blog, it sounds like he has found the investors to move forward with this

https://www.eurekalert.org/pub_releases/2015-01/smri-usc012715.php
 
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donsf448

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What does Phase III really mean (other than it passed phase II). Does that signal a good chance of the drug's efficacy and safety?
 
br1

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donsf448 said:
What does Phase III really mean (other than it passed phase II). Does that signal a good chance of the drug's efficacy and safety?
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Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

source: https://www.nlm.nih.gov/services/ctphases.html
 
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donsf448

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looking at the rest of the source:

  • Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

  • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

  • Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

  • Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
Seems like they wouldn't waste money on phase III if Phase I or II didn't have some promising results.
 
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occulus said:
This chart needs to be corrected; there has been no confirmation that anything is currently in Phase III trials. Follica has said it hasn't begun its third trial, Histogen claims it will start this month but there is no evidence as such, and Shiseido isn't in Phase III.
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Shiseido is put in Phase III because it can receive conditional market approval after Phase II, so may as well keep the chart simple.

Agreed about the other two, though.
 
Admin

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occulus said:
This chart needs to be corrected; there has been no confirmation that anything is currently in Phase III trials. Follica has said it hasn't begun its third trial, Histogen claims it will start this month but there is no evidence as such, and Shiseido isn't in Phase III.
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From @Swoop who helped me make the page:

"Follica technically isn't even a third phase trial
But it's 510K approval
So we put it under phase 3, since it is close to commercialization if all goes well
Shisheido we put in phase 3 because japan regulatory approval allows for the release of a treatment after one phase
It's not like in the USA"
 
soo

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When I just started taking finasteride and regaine, how likely is it that there will be something out in - let's say - 5 years that will definitely stop further hair loss? So if you ignore the regrowth as a criteria for "the cure"?
 
Omega2327

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soo said:
When I just started taking finasteride and regaine, how likely is it that there will be something out in - let's say - 5 years that will definitely stop further hair loss? So if you ignore the regrowth as a criteria for "the cure"?
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Fairly likely with Shiseido/Replicel. Possibly as early as next year
 
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NewUser

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Pavi said:
Its definitely under phase 1....
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Aclaris' topical jakinib is ATI-50002. They will submit an IND for 50002 anytime now and plan to do a phase 2 dose ranging trial second-half of this year.

In addition to this oral formulation of the JAK 1/3 inhibitor, Aclaris also plans to develop a topical formulation, known as ATI-50002, for the treatment of AA, vitiligo, and androgenetic alopecia (Androgenetic Alopecia).

"...a Phase 2 dose ranging trial with ATI-50002 for the topical treatment of patchy alopecia areata in the second half of 2017.
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ETA: According to a news release in May, another series of topical is under development for Androgenetic Alopecia.

Finally, Aclaris is developing another series of topical JAK inhibitors for the treatment of androgenetic alopecia (Androgenetic Alopecia).
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MrV88

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İs histogen really in phase 3? Something official?

And something new about the 510k from Follica?
 
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