Kerastem Receives Conditional Approval from FDA for Alopecia Trial

[c_super2]

SAN DIEGO, July 28, 2015 /PRNewswire/ -- Kerastem Technologies announce that the Company has received notice of conditional approval from the U.S. FDA Center For Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies to conduct a clinical trial investigating the safety and feasibility of the Company's technology for the treatment of female and early male pattern baldness (androgenic alopecia).
The phase II study, known as the STYLE trial, follows initial clinical work in Europe and Japan. This clinical experience served as a basis for the FDA IDE submission. The data will be presented in September at the 2015 International Society of Hair Restoration Surgery meeting in Chicago. STYLE is a 70 patient controlled trial that is expected to begin enrollment in late 2015 at up to eight (8) centers within the United States. The primary endpoint is safety and tolerability of the treatment and secondary endpoints include change in hair growth and density.
According to Principal Investigator Ken Washenik, MD, PhD, Medical Director--Bosley Medical Group, and Clinical Assistant Professor, Department of Dermatology, New York University School of Medicine, "I have been heavily involved in the care and research of alopecia patients and treatments for over 20 years, including the use of cellular based approaches. As principal investigator of the STYLE trial, I look forward to evaluating this exciting new approach to the treatment of hair loss."
The global hair loss market is a $7B cash pay business growing annually at 4.8%. "The hair market has few acceptable solutions for early hair loss, particularly in women," according to Bradford Conlan, CEO of Kerastem. "STYLE represents a defined clinical pathway in the United States and complements our commercial efforts in Europe and Asia," added Mr. Conlan. The Company's platform technology is CE Mark approved and available for patients with alopecia in Europe. Kerastem is currently engaged in market development with select commercial partners.
For more information on STYLE, visit www.kerastem.com
About Kerastem
Kerastem Technologies is a private company owned by Bimini Technologies, and holds global and exclusive rights to commercialize Cytori Therapeutics, Inc.'s Celution® Technology for alopecia and hair related indications. The Bimini portfolio of products also includes Puregraft (www.puregraft.com, www.thefatexperts.com) the world's leading fat grafting technology.
The STYLE trial is now listed on www.clinicaltrials.gov at the following location:
https://clinicaltrials.gov/ct2/show/NCT02503852?term=Kerastem&rank=1
Contact: Support@kerastem.com
Logo - http://photos.prnewswire.com/prnh/20150728/247048LOGO


http://www.prnewswire.com/news-rele...al-from-fda-for-alopecia-trial-300119592.html
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[benjt]

Are there any photos or Phase 1/2a data?

This seems pretty similar to all the other recent approaches with adipose-derived cells (if I'm not mistaken, AAPE is one of them).

 

[resu]

...of female and early male pattern baldness (androgenic alopecia).

Basically finasteride 2.0 confirmed, forget about regrowth.

 

[c_super2]

Basically finasteride 2.0 confirmed, forget about regrowth.

Scroll down for before and after pictures:


http://kerastem.com/


there is regrowth.

 

[resu]

I need that then, that amount of regrowth would be enough for me to make me happy for a few years.

 

[hellouser]

Are there any photos or Phase 1/2a data?

This is after only one treatment:

 

[Parsia]

This is after only one treatment:

Oh My ! Hair has changed around 1.5 Norwood at least !!!

Result is great.

 

[hellouser]

Oh My ! Hair has changed around 1.5 Norwood at least !!!

Result is great.

Just keep in mind: That's after only ONE treatment and nothing else; no finasteride, no minoxidil, no nizoral, no AAPE, no setipiprant, no sulphasalazine, no dermarolling, no RU.... NOTHING.

 

[Donc83]

Great only about 10 years away right? Sorry for being down just one of those days after looking hard in the mirror.

 

[hellouser]

Great only about 10 years away right? Sorry for being down just one of those days after looking hard in the mirror.

I really doubt it. AFAIK, they've already done clinical work in Japan so with their new laws, we could be looking at just 2-3 years... or sooner. USA is a complete joke, so yeah, 10 years with the FDA's bullshit regulations.... the FDA doesn't give a fuck about your physical or psychological health.

 

[c_super2]

Kerastems website says they are enrolling people for efficacy trials and they are based in San Diego, CA I believe.


I wonder if Kerastem will halt further hair loss/baldness. That would be a godsend for me and an effective cure for younger guys.

 

[Donc83]

I really doubt it. AFAIK, they've already done clinical work in Japan so with their new laws, we could be looking at just 2-3 years... or sooner. USA is a complete joke, so yeah, 10 years with the FDA's bullshit regulations.... the FDA doesn't give a fuck about your physical or psychological health.

Thanks for the response man. I am still bummed out from CB receiving a 2021 arrival date. Damn why can't we just get something more effective and safer that finasteride. I just started taking finasteride again about 3 weeks ago and I don't like taking a pill everyday and it gives me slight sides but Im going to try to get through them.

 

[hellouser]

Thanks for the response man. I am still bummed out from CB receiving a 2021 arrival date. Damn why can't we just get something more effective and safer that finasteride. I just started taking finasteride again about 3 weeks ago and I don't like taking a pill everyday and it gives me slight sides but Im going to try to get through them.

Because Cosmo doesn't respect baldness as much as it thinks acne needs yet another treatment. Forget about CB anyway, setipiprant should blow it right out of the water.

As for finasteride, you don't need to be on it every day. Your DHT levels will take about 7 days (sometimes more) to return to baseline. You should be fine taking it every other day or even twice a week.

 

[dark train]

http://kerastem.com/
Just above the pictures there are the names of the clinics where it's available (Swiss, SPain and Japan)

 

[Giiizmo]

http://kerastem.com/
Just above the pictures there are the names of the clinics where it's available (Swiss, SPain and Japan)

There is no mention of alopecia after a quick glance at their Swiss website so this treatment doesn't seem to be available yet.

 

[existence]

From the diagrams and reading the trial description, it's fat grafting enriched with adipose derived stem cells.
Not new in plastic surgery, they are used for facial and breast augmentation.
Just search cell assisted lipotransfer.

 

[I.D WALKER]

Get your passports in order fellooows.

 

[resu]

Because Cosmo doesn't respect baldness as much as it thinks acne needs yet another treatment. Forget about CB anyway, setipiprant should blow it right out of the water.

As for finasteride, you don't need to be on it every day. Your DHT levels will take about 7 days (sometimes more) to return to baseline. You should be fine taking it every other day or even twice a week.

From a busyness standpoint it makes more sense for them to target the acne version first because they don't have to wait months to see any results.

 

[g.i joey]

This is after only one treatment:

the fact that you're backing this gives me hope that its a legit treatment.. imo this is exactly what im using finasteride for, 2 or 3 years there should definately be a new viable treatment out so im gonna ride out any weird effect finasteride gives me.

 

[Parsia]

Just keep in mind: That's after only ONE treatment and nothing else; no finasteride, no minoxidil, no nizoral, no AAPE, no setipiprant, no sulphasalazine, no dermarolling, no RU.... NOTHING.

And its not on mice , and the regrowth is a lot and its not transplant and its not Follicept !! haha .

With considering all this , This is look like cure to me my friend.