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TOPIC: SUI paper and competitive cell-based treatments

SUI paper and competitive cell-based treatments 18 Sep 2013 12:33 #870

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Most of you surely will have noticed that Tom Baker tweeted the link to a new article from Gotoh/Yamamoto last night in the Urology Journal on the Stress Urinary Incontinence pilot.

If not- here is the link - SUI pilot results

This is the result of the May 25 2011 announcement which said this:

MHLW approval to proceed with the study reflects Cytori's open operating system model in which hospital-based Celution® Systems may be used by different specialties for their own clinical research. This allows potential applications beyond our core focus to be advanced by independent groups. The study may be used as the basis for a pivotal trial or to apply for regulatory approvals both in Japan and around the world.
"This is an example of a translational medicine application that has evolved into an approved clinical study," said Marc Hedrick, President of Cytori. "Our intention is to leverage this data, should we see positive results, to work towards making this a standard of care for patients around the world." This open label, non-randomized study will enroll up to 20 patients with mild incontinence, both females and males, at the Nagoya University Graduate School of Medicine and a potential second site. Each patient will receive an injection of Celution® derived ADRCs directly into the urethral sphincter and a periurethral injection of ADRC-enhanced fat graft to act as a bulking agent. Patients will be assessed for incontinence (via 24 hr. pad test), quality of life and sphincter function. The study will be led by Momokazu Gotoh, MD, Ph.D., Professor and Chairman of the Department of Urology and Tokunori Yamamoto, MD, Ph.D., Associate Professor Department of Urology at Nagoya University Graduate School of Medicine.


Just as stated in the abstract only 11 patients were done and results were pretty decent. This IS an unmet need, since males who received a prostatectomy (surgical removal of the prostata as a result of cancer) develop this almost always, since the support of the sphincter is gone and those folks are normally older when this develops naturally to some degree. Female incontenence is more widespread but basically easier to treat, since those holes of tissue/voids are not there.
For this reason the Cytori treatment is very elegant- fill the void with fat and strengthen the muscle i.e. sphincter.

In the past I have done a lot of research on this- of course there is an application write- up on the page- and the competitive cell based treatment is from cultured muscle cells- in the US Cook Myosite already has a Phase III against FEMALE SUI (>200 patients) and in Europe- French Celogos is developing the same therapy- from there this image:


Academia is involved too- this international study is just what we need to compare:

2012;2012:898535. doi: 10.1100/2012/898535. Epub 2012 Jul 31.
Muscle-derived cells for treatment of iatrogenic sphincter damage and urinary incontinence in men.
Gerullis H, Eimer C, Georgas E, Homburger M, El-Baz AG, Wishahi M, Borós M, Ecke TH, Otto T.
Source
West German Cancer Center (WTZ), University of Essen, Essen, Germany. This email address is being protected from spambots. You need JavaScript enabled to view it.
Abstract
INTRODUCTION:
Aim of this study was to assess the safety and efficacy of injection of autologous muscle-derived cells into the urinary sphincter for treatment of postprostatectomy urinary incontinence in men and to characterize the injected cells prior to transplantation.
METHODS:
222 male patients with stress urinary incontinence and sphincter damage after uroloical procedures were treated with transurethral injection of autologous muscle-derived cells. The transplanted cells were investigated after cultivation and prior to application by immunocytochemistry using different markers of myogenic differentiation. Feasibility and functionality assessment was achieved with a follow-up of at least 12 months.
RESULTS:
Follow-up was at least 12 months. Of the 222 treated patients, 120 responded to therapy of whom 26 patients (12%) were continent, and 94 patients (42%) showed improvement. In 102 (46%) patients, the therapy was ineffective. Clinical improvement was observed on average 4.7 months after transplantation and continued in all improved patients. The cells injected into the sphincter were at least ~50% of myogenic origin and representative for early stages of muscle cell differentiation.
CONCLUSIONS:
Transurethral injection of muscle-derived cells into the damaged urethral sphincter of male patients is a safe procedure. Transplanted cells represent different phases of myogenic differentiation.


Fortunately it is a free paper, which I can analyse and compare to the Nagoya study in the next few weeks. After that assessment I probably will be able to tell whether the Cytori treatment will be adopted soon by the Japanese health system, based under the new legislation which will be voted upon on Saturday- September 21.

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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:

SUI paper and competitive cell-based treatments 18 Sep 2013 20:21 #871

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OK fine, better, but even in the Cytori cases..for most, 40% of the piss still leaked as before.

I think what would perhaps add more value to the raw statistics is did they have concious control ? If they mostly leaked at night when asleep then but control durning the day... I say we have decent benefit. If they can still leak at any time and thus have to wear a diaper all the time then I say the benefit is minimal.

I wonder if larger volumes of fat transplant could improve these results ?

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SUI paper and competitive cell-based treatments 19 Sep 2013 09:43 #872

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hedge- I think you do have a point that unless one has continence, the drawbacks in wearing diapers remain. A placebo does not make sense to me- the past was the control I guess.

Anyway- I spent several hours searching and reading on the subject and will not put more energy into the application- there are a few recent summary papers, which describe the pre-clinical and clinical activities on SUI very well- no need for me to "copy" that work. I attach a paper which I thought was the best one I have read-

SC therapy for SUI- A critical review by Lin and Lue


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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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