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TOPIC: Kerastem completes enrollment in Alopecia study

Kerastem completes enrollment in Alopecia study 26 Sep 2016 07:15 #7711

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Sep 26, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that its licensee Kerastem Technologies, LLC, has completed enrollment of STYLE, a US phase II clinical trial investigating early stage female and male pattern hair loss.
“Cytori Cell Therapy is a broadly applicable cell therapeutic platform used now in multiple mid and late stage clinical trials in the US, Japan and Europe. Our partner Kerastem is focused on developing Cytori technology for men and women with alopecia,” said Dr. Marc H. Hedrick, President & CEO of Cytori. “Early proof of concept clinical data has shown promise and Kerastem expects a read out from the trial in approximately one year. This therapy if approved could create a significant value for our stockholders.”
STYLE is a phase II randomized, blinded, and controlled investigation of Kerastem therapy in early stage female and male pattern baldness. A total of four clinical trial sites treated a target enrollment of 70 patients in the United States. The primary endpoint of STYLE is safety and tolerability at six months and subjects will be followed for 12 months. Subjects participating in STYLE received one of four treatment arms, including fat plus ADRCs.
Outside of the United States, Kerastem is actively involved in market development, with Kerastem therapy currently being offered at a number of clinics in Europe & Japan.
To learn more about Kerastem or the STYLE Clinical Trial, please visit www.kerastem.com or clinicaltrials.gov/ct2/show/NCT02503852?term=Kerastem&rank=1

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Kerastem completes enrollment in Alopecia study 26 Sep 2016 07:23 #7712

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Brad Conlan and Eric Daniels are doing a great job for Kerastem. This is an app with quite some potential I believe.

Anyway- also wanted to say, that I will be taking a break in all things web activities, since I will be on holiday in Northern Spain for a little over a week.
I would not mind if Cytori announces the closing of a OA partner deal in my absence...not at all. :grin:
Till than. :bye:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Kerastem completes enrollment in Alopecia study 26 Sep 2016 13:49 #7713

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Fas, have a great Holiday. :bye:

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Kerastem completes enrollment in Alopecia study 16 Jan 2017 20:48 #8529

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This is an older thread that may well be worthwhile reviewing.

It is true that scleroderma is crucial for CYTX going forward but we should not neglect the potential of the Alopecia indication to validate the whole autologous ADRC space and Celution in particular. An announcement concerning full trial enrollment was made in September 2016. The primary and secondary outcome measures were for 6 months so it is not inconceivable that we may very well have material information even before the scleroderma data comes out.

In the below referenced article which came out at about the same time as the announcement of full enrollment I note the following statement:

An ongoing phase 2 FDA-approved STYLE 6-month study sponsored by Kerastem conducted by Aronowitz and colleagues has enrolled 70 patients with pattern hair loss at four sites. Early results demonstrate a significant improvement and a very low morbidity for grafting fat in the scalp, Aronowitz said."

www.healio.com/aesthetics/body-aesthetics/news/online/%7B751013d9-bda0-4dfe-a06d-b30dae330462%7D/cell-enriched-fat-may-represent-alternative-for-treating-pattern-hair-loss

Maybe we should be asking about the terms of partnership agreement between Cytori and Kerastem. I would also like to know who the major shareholders are (and/or their proxies)?

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Kerastem completes enrollment in Alopecia study 17 Jan 2017 03:55 #8530

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I think you are right in your assumption John.
The Kerastem news is likely to come ahead of Scleroderma.
Obviously- something is coming our way in ortho (Bone Repair), which to me is 99% certain to be the dental app ...or possibly- Cugat and ACL? (but ACL is not bone repair)

Still the Nagoya- PAD/CLI/Burger´s disease is to come and in view of all PI studies plenty more is possible, however all these announcements will be wasted if no financial deal is closed before these events. :really:

Anyway- some off-topic, but related to Aronowitz (who also did the study on the extraction machines, in which Celution came out as a clear superior device), I was reading a Mercola article on detox where he talked with Susanne Somers, who got her boob job done after her breast cancer surgery, about 4-5 years ago-

Interestingly, Suzanne actually became the first woman in the U.S. to undergo surgery in a legal FDA-approved clinical trial of breast reconstruction, regrowing the breast she lost to cancer through a novel process using her own fat and stem cells.

The procedure was developed by Dr. Kotaro Yoshimura from the University of Tokyo. It took three years to get approval from the Food and Drug Administration (FDA) to conduct a clinical trial in a U.S. hospital. In the meantime, Dr. Yoshimura taught the procedure to Dr. Joel Aronowitz, who performed it on Suzanne.

"I thought it was so historic to be the first woman to legally... regrow my breast using my own fat and my own stem cells. The result is absolutely beautiful and fulfilling...


  • “What they did was take the fat from my stomach. They took out the stem cells, discarded the weak ones, kept the strongest ones, spun them, and put them into that fat...The best way I can describe it is using a turkey baster to inject [the stem cell-loaded fat] into my breast until it became the size of the other one. The result is beautiful.

    “I don’t know why this hasn’t become the standard now because it’s safer. Every time you put a foreign object into a body, you’re going to have some trouble. Every woman I know who has implants has some troubl
  • e.”

    Dr. Aronowitz has done over 1,000 of these breast reconstructions now. He's at the Cedar-Sinai Medical Center in Los Angeles, and is still doing them.


    If this guy (Aronowitz) is so hot on Celution, why isnt he using it (the manual stuff is illegal too :KO: )

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    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

    Kerastem completes enrollment in Alopecia study 17 Jan 2017 06:06 #8532

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    Fas, is it possible that Aronowitz is using the Celution System (which may have even been donated).

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    Kerastem completes enrollment in Alopecia study 17 Jan 2017 13:11 #8547

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    rodney.strongg wrote: Fas, is it possible that Aronowitz is using the Celution System (which may have even been donated).


    Of course- he has a Celution as Principal Investigator for STYLE.

    From the lack of revenues in the US I conclude he is not using it for breast reconstruction.

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    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

    Kerastem completes enrollment in Alopecia study 17 Jan 2017 15:21 #8551

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    Fas, I will try to find out why Aronowitz is apparently not using Celution on breast reconstruction.

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