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TOPIC: Russian Trials

Russian Trials 02 Jan 2017 07:37 #8397

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We don't talk much about Russia on this board, but there is a lot going on there. Complimentary studies to Cugat's ACL treatment and Finland's ED study as well as SUI.

clinicaltrials.gov/ct2/results?term=celution+system&Search=Search

I have never seen the published data from Cugat's ACL presentation from June.

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Russian Trials 02 Jan 2017 09:34 #8400

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DOV wrote: We don't talk much about Russia on this board, but there is a lot going on there. Complimentary studies to Cugat's ACL treatment and Finland's ED study as well as SUI.

clinicaltrials.gov/ct2/results?term=celution+system&Search=Search

I have never seen the published data from Cugat's ACL presentation from June.


Yes- the activity level in Moscow is quite impressive. There basically are two hospitals carrying out open label feasibility studies in various indications. It started with the Burnasyan Federal Medical Biophysical Center, on which I have reported several studies in the past. Now however the Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati is the more active one (all according to clinicaltrials.gov- of course, most international studies are NOT reported there)

The summary list for the last clinic, shows 7 entries-

Linke- HERE

The last one is the most interesting- this is also knee OA and open label, but with 200 patients and full enrollment is already expected in October 2017. The procedure is debridement plus cells. :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:

Russian Trials 02 Jan 2017 11:11 #8401

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For those who have been reading my page a while longer- will remember the Naples study on chronic wounds in lower limbs of PAD patients, which came out in 2013. The study was amazing and the results were, which you can see on the before-after images in the paper below-

File Attachment:

File Name: 2013-ADRCs-chronic-ulcer-padpatients-naples.pdf
File Size: 2,536 KB


I consider the whole related arena for PAD, CLI and chronic ulcers pretty much related and in view of the rise in the number of diabetic patients, as a colossal market which is badly served by conventional- as well as regenerative medicine. ADRCs should do very well there.
One can see movement now-
Odense University Hospital ( the one with the lymphedema study) started at 30 patients clinic- link- HERE

and even more rewarding- the Cytori saviors from Assistance Publique Hopitaux de Marseille, who did SCLERADEC I, will start the REGENDER clinic in February 2017- 45 patients- link HERE

and than we still have the Nagoya study which should be finished now with 40 patients, which Hedrick vaguely mentioned in February 2016 at a conference and should be the next big Japanese surprise after the limited OA approval.

September 13, 2012
Multicenter Investigator-Sponsored Cell Therapy Study for Peripheral Artery Disease Approved in Japan
SAN DIEGO--Cytori Therapeutics (NASDAQ: CYTX) today announced that a 40-patient, multi-center investigator-sponsored and funded clinical study in Japan using the Celution® System has been approved under the Ministry of Health, Labor and Welfare (MHLW) Guidelines on Clinical Research Using Human Stem Cells.
The study will investigate the use of patients’ own adipose-derived stem and regenerative cells (ADRCs) processed by the Celution® System for peripheral artery disease (PAD) or arteriosclerosis obliterans (AO). PAD or AO are common circulatory problems in which narrowed arteries reduce blood flow to the limbs. The principal investigator will be Toyoaki Murohara, M.D., Ph.D., Professor and Chairman, Department of Cardiology at the primary trial center, Nagoya University Graduate School of Medicine. The trial will include two additional Japanese sites.
“It has been reported by many researchers domestically (Japan) and overseas that transplantation of ADRCs stimulates vascularization of an ischemic area,” said Dr. Murohara. “Specifically, positive clinical results were reported with regards to the treatment for ischemic heart failure in Europe using ADRCs. Although Japan has lagged far behind in this field, I believe that approval by MHLW under the new clinical research guidelines to study ADRCs for limb ischemia is a big step for medical care of vascularization therapy in Japan.”
This multi-center, single arm study will enroll up to 40 patients with peripheral artery disease, Burger’s disease, or with severe limb ischemia caused by connective tissue disease. Each patient will receive an injection of their own ADRCs into the skeletal muscle at the affected area on the limb. Patients will undergo follow-up examinations at one week and at one, three and six months with primary endpoints of safety and limb salvage rate as compared to conventional treatment.

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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:

Russian Trials 02 Jan 2017 12:26 #8402

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***I consider the whole related arena for PAD, CLI and chronic ulcers pretty much related and in view of the rise in the number of diabetic patients, as a colossal market which is badly served by conventional- as well as regenerative medicine. ADRCs should do very well there.***

I would certainly agree Fas...the dates of research and no progress to market is so sad but typical.
I would also throw in chronic wounds from burns which I still believe is the best path to break into the burn market vs DOV's talk of the "standard of care" approach.
Sadly it seems we will have at least a 2 year wait until we hear results from the REGENDER trial and likely 6 years to market

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Russian Trials 02 Jan 2017 22:03 #8404

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The number of trials running concurrently using Celution and ADRC in PAD is very impressive, Russia, Denmark, France and Japan. These trials can provide independent confirmation that will/may be sufficient to expedite approval in Japan (and not only) under the new liberalized legislative framework.

The Naples study was very impressive and if one also considers the treatment effect in scleroderma, fistula and burn then we can have a high degree of confidence that it will work in PAD, CLI etc.

Lets not forget that Chris Calhoun was looking at getting a deal going with the Gulf states to address diabetes related PAD,CLI which is responsible for huge levels of amputations.

This indication alone would normally get the market excited, but no such luck, ........ yet.

All of these trials can provide a very visible treatment effect quickly (6 months) assuming efficacy. CYTX should have access to data relatively quickly. This data can provide leverage for a good deal assuming they are serious about negotiating a deal?

Independent investigator studies have been and continue to be the salvation of this company. The ease of use of this technology is a radical differentiating factor along with the fact that the patient has his own medicine cabinet stored in his(her) body. Dealing with this treatment paradigm has conventional drug delivery companies (& FDA) in a quandary.
The FDA must approve a treatment if it is efficacious. The question is which BP/BB will break ranks to partner with us, and/or will Hedrick & Co ever be prepared to partner. :KO:
The following user(s) said Thank You: rodney.strongg

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Russian Trials 03 Jan 2017 07:17 #8406

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myownhedgefund wrote: ***

I would certainly agree Fas...the dates of research and no progress to market is so sad but typical.
I would also throw in chronic wounds from burns which I still believe is the best path to break into the burn market vs DOV's talk of the "standard of care" approach.
Sadly it seems we will have at least a 2 year wait until we hear results from the REGENDER trial and likely 6 years to market


I am not sure what you mean by DOV's talk of the "standard of care" approach. You make that sounds like a strategy! SOC just happens as doctors report outcomes and publish results. It takes time to get the word around and become "standard of care." I believe that IF the therapy proves to have remarkable results through IV injection or otherwise, it will become standard of care. That may take five or six years from now before 100% of burn victims are treated with Celution therapy.

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Russian Trials 03 Jan 2017 10:37 #8408

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I know what SOC means.
I believe it will be a harder sell for burns than you think.
It may have its place and the best path in (again, imho) is the chronic wounds that can occur and be very difficult to treat for final healing. Then they can try to build.
The IV pathway ? We will have to see.
You know my thoughts on 6k patients treated in 2020 for this app !

Forgot to add....I do hope you are more correct than I. We shall see.
I do prefer the Riley approach as being conservative and raising above expectations as opposed to having to lower them.

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