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TOPIC: Scleroderma Foundation Web Site

Scleroderma Foundation Web Site 19 Sep 2015 09:56 #5236

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www.scleroderma.org/site/MessageViewer?em_id=23781.0&dlv_id=25601#.Vf125unfFvs

Hedrick mentioned an information blitz beginning in September from the Scleroderma Foundation. I guess this is it.

I signed up to receive their e-mails every Friday. In theory this should help locate volunteers for the STAR trial.

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Scleroderma Foundation Web Site 19 Sep 2015 10:41 #5237

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Wow- we seem to be making progress... :whistle:

The link to the clinicaltrials.gov record brings the surfer to an up to date record (August) of the trial. In the past they tended to post one initial record and maybe updated that record once in only three years or so, :whistle:

The 18 trial sites now listed:

United States, Arizona
Arizona Arthritis and Rheumatology Research, PLLC Not yet recruiting
Phoenix, Arizona, United States, 85253
Contact: Mishan T Samaraweera, B.S. 602-386-4969 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Paul Caldron, D.O.
United States, Arkansas
Baptist Health Center for Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clint W Abner, Ph.D. 501-224-1348 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: John Yokum, M.D.
United States, California
Arthritis Associates of Southern California Not yet recruiting
Los Angeles, California, United States, 90045
Contact: Emma Hasan 310-297-6812 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Daniel Furst, M.D.
UCLA David Geffen School of Medicine Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Maricela Rodriguez 310-825-4744 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Suzanne Kafaja, M.D.
United States, District of Columbia
Georgetown University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Carolyn Fridley 202-444-6211 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Virginia Steen, M.D.
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Julie A Johnson 312-503-2338 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: John Varga, M.D.
United States, Kansas
Heartland Research Associates Recruiting
Wichita, Kansas, United States, 67207
Contact: Alyson Fry 316-689-6609 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Sadi Shahouri, M.D.
United States, Kentucky
Central Kentucky Research Associates, Inc. Recruiting
Lexington, Kentucky, United States, 40509
Contact: Debbie Dyer, RN, BSN 859-264-8999 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Mark Adams, M.D.
United States, Massachusetts
Boston University Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Nina Kishore, MPA, MS, MPH 617-414-2509 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Robert Simms, M.D.
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jennelle Shaw 734-936-4555 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Elena Schiopu, M.D.
West Michigan Rheumatology, PLLC Not yet recruiting
Grand Rapids, Michigan, United States, 49546
Principal Investigator: R Martin, M.D.
United States, New Jersey
Robert Wood Johnson Medical School Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Deborah McCloskey, RN 732-418-8478 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Vivien Hsu, M.D.
United States, New York
Hospital for Special Surgery Not yet recruiting
New York, New York, United States, 10021
Contact: Eliza Pelrine 212-774-2123 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Robert Spiera, M.D.
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Edna Scarlett, CCRC 919-684-6150 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Ankoor Shah, M.D.
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Sonya Crook 216-444-3290 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Soumya Chatterjee, M.D.
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Robin Neubauer 215-615-0773 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Chris Derk, M.D.
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Dana Ivanco 412-648-7040 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Robyn Domsic, M.D.
United States, Texas
University of Texas Houston Medical School Not yet recruiting
Houston, Texas, United States, 77030
Contact: Patricia Gonzalez, LVN 713-500-7118 This email address is being protected from spambots. You need JavaScript enabled to view it.
Principal Investigator: Maureen Mayes, M.D.

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Scleroderma Foundation Web Site 19 Sep 2015 17:44 #5238

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Home Page Promo:

STAR Clinical Trial Now Enrolling Patients

If you (or someone you know) have impaired function of the hands and Raynaud Phenomenon due to scleroderma, you may be interested in the STAR clinical trial. The STAR clinical trial is designed to study the use of a patient’s own Adipose-Derived Regenerative Cells (ADRCs), prepared using the investigational Celution® Device, in the treatment of scleroderma affecting the hands and fingers. The study will be conducted in patients who are currently on medical therapy and still have impaired hand function and Raynaud’s phenomena. The STAR clinical trial will enroll 80 patients in multiple centers in the United States.

Dinesh Khanna, M.D., M.S., Director of University of Michigan Scleroderma Program and principal investigator of the STAR trial shared his enthusiasm for hand management in scleroderma, that affects over 90 percent of patients with scleroderma. Hand symptoms are the leading cause of disability in this patient population, more disabling than rheumatoid arthritis, and severely negatively impact quality of life and work productivity. This study addresses this unmet need. Details of the study can also be found on clinicaltrials.gov.

For more information, please visit www.startrial-us.com .

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Scleroderma Foundation Web Site 20 Sep 2015 12:33 #5239

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It appears that only 3 sites are actively enrolling. To achieve an enrollement target of 80 will take some time if all sites are not up. I am hoping that all sites will be functional and enrolling within the next couple of months.

Keep in mind that some sites will be high enrolling (10-20% of 80) and some sites will only enroll 1-2 patients for the entire study. This is how it typically will pan out since some sites have adequate staff with advertising and recruiters to help boost enrollment. Other sites will not have adequate staff to accommodate more than a few patients, but the sites chosen are probably the most capable in the nation. Here's to a smooth and quick enrollment period for STAR.

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Scleroderma Foundation Web Site 21 Sep 2015 11:10 #5241

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As FAS has pointed out, the recruiting activity dates back to August. Hedrick indicates that most of the activity comes after Labor Day.

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Scleroderma Foundation Web Site 22 Sep 2015 09:59 #5242

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As with OA the scleroderma trial should enroll very quickly. I cannot believe that there will be a huge delay in finding patients interested in participating in a safe trial that can have a material impact on their quality of life. These are specialist units with the bulk of the target population on their books. The biggest issue is probably getting the Celution devices shipped to all these sites and training staff in its use. Probably best to have Cytori technicians undertake the processing. As stated before it is quite easy to do multiple patients in one day for this procedure.

I wonder how long it will take for us to hear that a similar registration quality trial is going to be undertaken in Japan. Celution is ideal for the Japanese market given their greater affinity to use autologous as opposed to allogeniec products. Also as it is autologous no need to worry about
about gaijin products not working on the unique Japanese DNA/body. Their preoccupation and insistence on re-trialing successful drugs on Japanese patients for "cultural" reasons will not be such a big issue.

This would also be a low hanging fruit for Lorem to try in China. I imagine that in a country with such a huge population it would not take long to run a trial. :grin:

I wonder what type of discount factor analysts will use in valuing CYTX in the myriad of autoimmune diseases that ADRC could potentially treat .......... once we have an approval in place. :winky:

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Scleroderma Foundation Web Site 22 Sep 2015 10:26 #5243

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In theory this should help locate volunteers for the STAR trial[/quotel

Dov,

My feeling is that the Scleroderma community is a tight knit group that are very tuned it to innovative new treatments. I think that as we see information regarding the European successes understood by the community the enrollment will be completed sooner than later. I pray the therapy is able to help these poor people. The rest will take care of itself.

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Scleroderma Foundation Web Site 26 Sep 2015 10:24 #5255

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This video is about hand care for those with Scleroderma. For those interested in knowing more about this disease, I would recommend watching it. If I had this disease, I would already be standing in line to get into the STAR trial.

What I would really like to see are pictures before and after treatment with Cytori's EMMS-50. We have seen the published one year results and they read very well. I would like to be able to relate to these results visually. Releasing before and after pictures would go a long way to help convince investors the stem cells work. However, doing so carries the risk of increasing the stock price. :bash: :bash:

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Scleroderma Foundation Web Site 28 Sep 2015 06:50 #5256

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DOV

While releasing encouraging efficacy pictures couldn't hurt I believe many view the risk beyond just if stem cells show improvement.

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Scleroderma Foundation Web Site 04 Oct 2015 11:25 #5277

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Here is a bit more color (photos) so to speak with regard Scleroderma. The article also points out that SVF is very interesting for facial reconstruction due to scleroderma when used with adipose filler.

books.google.co.nz/books?id=2fRwCgAAQBAJ&pg=PA363&lpg=PA363&dq=French+Scleroderma+Research+Group&source=bl&ots=Rbh-edpQ4l&sig=VC0oqp7BzkekrSz5Rv8AaCsTzww&hl=en&sa=X&ved=0CCsQ6AEwA2oVChMIv6fal5epyAIVRiOmCh0B3g29#v=onepage&q=French%20Scleroderma%20Research%20Group&f=false

This indication should enroll quickly. While not necessarily being a large indication in the USA, the worldwide number of patients is not insignificant. Once the ADRC - Celution process is recognized as being effective there should be quite a considerable interest on the part of patients and doctors to implement it.

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Scleroderma Foundation Web Site 04 Oct 2015 15:07 #5278

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Clinical trials.gov re CYTX STAR trials indicates 3 active sites in August and then 6 active sites as of mid September.

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Scleroderma Foundation Web Site 22 Oct 2015 14:31 #5332

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As of October 21, only 7 sites are open for patient enrolment. It appears that the study is progressing slower than expected (very slow).

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Scleroderma Foundation Web Site 22 Oct 2015 16:57 #5337

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Guidance was for something like a year or so....some think they were padding and will beat this goal. We shall see.
Also remember it is possible that a small number of sites will enroll the bulk of participants.

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Scleroderma Foundation Web Site 22 Oct 2015 17:21 #5338

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Mr. Hedge, I am surprised that even U. of Michigan, where Dr. Kana (spelling?) is based, has not open for patient recruitment.

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Scleroderma Foundation Web Site 23 Oct 2015 03:36 #5339

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well, we will get a official update in about 2 1/2 weeks.

Hedrick can explain then

I doubt the harder and longer course for Cytori projects can change too much :really:

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Scleroderma Foundation Web Site 23 Oct 2015 09:13 #5340

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Can things get any more disappointing with this Company :puke:

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Scleroderma Foundation Web Site 25 Oct 2015 13:50 #5341

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Dinesh Khanna, M.D., M.S., Director of University of Michigan Scleroderma Program and principal investigator of the STAR trial shared his enthusiasm for hand management in scleroderma, that affects over 90 percent of patients with scleroderma. Hand symptoms are the leading cause of disability in this patient population, more disabling than rheumatoid arthritis, and severely negatively impact quality of life and work productivity. This study addresses this unmet need.


The above quote is from a post from WST in this thread..

If you look at the latest record on clincaltrials.gov : HERE

you will see that Dr. Khanna is not mentioned anywhere as "Principal Investigator". Funny enough, Dr. Steve Kesten from Cytori is listed as "Study Director"- something which is very unusual, since the "independent academia" should be in-charge to publish the scientific results in due course without bias. :whistle:
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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:

Scleroderma Foundation Web Site 26 Oct 2015 00:05 #5342

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Could it be that Kesten is listed as the "Study Director" in order to facilitate the quick publication (announcement) of the clinical data rather than have it delayed by the needs of academics to publish? Not sure if this is :bash: or :vegas: . It is however a good observation. One thing for sure is that Dr Khanna's positive comment is not in any way diminished by his not being the designated Principal Investigator. :grin:

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Scleroderma Foundation Web Site 26 Oct 2015 15:39 #5345

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Fas

Since my 30+ years experiences in the biotech/pharma business are mostly in clinical r/d, I can comment my understanding of all these titles.

Principle investigators and co-investigators are usually referring to the MDs (actually)running the clinical studies (at the study sites). Dr. Khanna is the PI for the whole study, involving in the design of the study protocol, as well as the overall evaluation of the data. He should really be called principle consultant to the cytori STAR trial and he is probably paid as a consultant.

Indeed, Kesten is the study director for Cytori; he is listed so in the actual FDA approved clinical protocol (designed primary by Khanna and assisted by Kesten, with inpust from the actual study sites).

The seemly delay in the study at various sites may be due to 1. administrative changes at some study sites-such as languages, etc.; 2. IRB delay due to consent form matters; 3. extra time needed to set up the Cytori celution system, including extra time to find appropriate medical personnel to do certain procedure (Cytori celution system may not fit into normal medical practices and this may be why product introduction has been hard at this time to allow stronger sales even in China, Japan and EU; this may be why Okyano's commitment is very much exemplary).

Just my quick thoughts.
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Scleroderma Foundation Web Site 26 Oct 2015 16:04 #5346

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Thanks Franshei, appreciate your insight.

That all makes sense to me. :yep:

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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:
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