Welcome, Guest
Username: Password: Remember me
Cytori´s Platform applications
  • Page:
  • 1

TOPIC: Results of enterocutaneous fistula study published

Results of enterocutaneous fistula study published 22 Oct 2015 08:08 #5328

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication of the results of a pilot clinical trial of Cytori Cell Therapy™ for the treatment of recalcitrant enterocutaneous fistula in patients with inflammatory bowel disease. This single center, single arm exploratory study enrolled six patients with fistulas that had failed to heal following conventional therapy including antibiotics, drainage, irrigation and ileostomy. Four patients had fistula associated with Ulcerative Colitis (one following surgery for rectal cancer) and two patients had fistula secondary to Crohn’s Disease. All patients received a single treatment with the adipose derived cellular therapeutic injected into the peri-fistular region and into the fistula tract. Patients received a total dose of between approximately 1x107 and 1.4x108 adipose cells. Patients were followed for fistula closure and epithelialization at 4, 12, and 24 weeks after treatment.

Two serious adverse advents were observed in the trial. One patient had extended hospitalization resulting from relapse of their underlying Crohn’s disease and a second patient experienced a parastomal hernia. Neither complication was considered to be associated with adipose tissue harvest or delivery of the cell therapy.

A fistula closure rate of 83% (5 of 6 patients) was observed within four weeks after treatment. A fistula closure rate of 100% (all six patients treated) was observed at 24 weeks after treatment. A single patient had a recurrent fistula 10 months after the initial procedure related to a relapse in the primary disease.

This trial, published in the journal “Surgery Today”, was executed at the Osaka University Graduate School of Medicine in Osaka, Japan, by Professor Masaki Mori and colleagues. The study builds on prior reports using Cytori Cell Therapy™ in a different kind of enterocutaneous fistula (fistula-in-ano) published by Dr. David Borowski and collaborators at North Tees Hospital in the United Kingdom in the journal “Surgical Innovation”. A follow on European physician initiated trial for patients with fistula-in-ano is planned to begin enrollment later in 2015. More details can be found on clinicaltrials.gov (NCT02558543) and the company will provide updates as appropriate.

“This small but carefully performed trial led by the Chief of Surgery at Osaka University in Japan is encouraging for a number of reasons,” said Dr. Marc H. Hedrick, President & CEO of Cytori. “This trial supports other published clinical data reporting benefit of our cellular therapeutics on impaired wound biology through mechanisms of actions that are likely similar to that proposed in many conditions and clinical situations such as scleroderma and further supported in our BARDA funded preclinical work. Poor wound healing, broadly construed, represents a very large market opportunity therefore we are carefully evaluating the business case to expand similar clinical trials.”

A fistula is an abnormal tunnel linking the interior of the stomach or intestines to the skin such that the contents of the intestines leak through. They are associated with substantial pain, risk of infection, and reduced quality of life. Fistulas of this kind are both more common and more difficult to treat in patients with inflammatory bowel diseases such as Crohn’s Disease and Ulcerative Colitis. Fistulas occur in 20-40% of patients with Crohn’s Disease with approximately 90% of these requiring surgical intervention. More than 20% of patients do not achieve complete healing and recurrence is common, occurring in 20-35% of cases. The Crohn’s and Colitis Foundation of America estimates that as many as 1.6 million Americans are affected by inflammatory bowel disease. It has been estimated that the incidence of rectoanal fistula in the USA is 68,000-96,000 cases per year.

Mizushima et al, Surg. Today doi: 10.1007/s00595-015-1246-8 “A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula.” www.ncbi.nlm.nih.gov/pubmed/26342817

Borowski et al, Surg Innov. pii: 1553350615572656 “Adipose Tissue-Derived Regenerative Cell-Enhanced Lipofilling for Treatment of Cryptoglandular Fistulae-in-Ano: The ALFA Technique.” www.ncbi.nlm.nih.gov/pubmed/25710946

Statistical information on fistula in Crohn’s Disease cited from Geltzeiler et al (2014) Ann Gastroenterol 27 (4) 320-30 and from Nelson and Abcarian in “Anal Fistula: Principles and Management” edited by M Abcarian (2014) Springer NY

Other info from the Crohn’s and Colitis Foundation of America www.ccfa.org/assets/pdfs/updatedibdfactbook.pdf

Please Log in or Create an account to join the conversation.

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:

Results of enterocutaneous fistula study published 22 Oct 2015 08:39 #5329

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
Cytori received approval for rectal- and vaginal fistula´s back in July 2010, after which Borowski started work at Hartlepool and Tyne Hospital on Gary and other patients with cryptoglandular fistula.

So -after this news we can finally bury all hope that the work leading up to the approval in 2010 will ever return to the hands of Cytori and Olympus will bury the data to the detriment of all patients. Really low mentality those bastards. :evil:

Positive of course, that Cytori - although, not seeing it as a core app- supports further development and we know now for sure it works---

A fistula closure rate of 83% (5 of 6 patients) was observed within four weeks after treatment. A fistula closure rate of 100% (all six patients treated) was observed at 24 weeks after treatment. A single patient had a recurrent fistula 10 months after the initial procedure related to a relapse in the primary disease.


These results are outstanding - whatever way you look at it.. :cool:

Please Log in or Create an account to join the conversation.

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:

Results of enterocutaneous fistula study published 22 Oct 2015 10:44 #5330

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
Maybe the text from the abstract published in PubMed is of interest... :whistle: ...should be :grin:

A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula.
Mizushima T1, Takahashi H, Takeyama H, Naito A, Haraguchi N, Uemura M, Nishimura J, Hata T, Takemasa I, Yamamoto H, Doki Y, Mori M.
Author information
1Department of Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan, This email address is being protected from spambots. You need JavaScript enabled to view it..
Abstract
PURPOSE:
Adipose-derived stem cell (ADSC) transplantation is expected to be a minimally invasive, but effective, treatment for postoperative enterocutaneous fistulas associated with poor blood flow and chronic inflammation. The aim of this study was to assess the safety and efficacy of a novel ADSC therapy for this condition.
METHODS:
We conducted an open-label, single-arm exploratory phase I study to assess the safety and efficacy of a novel ADSC therapy. Using the Celution system, we isolated adipose-derived regenerative cells (ADRCs) containing abundant ADSCs from liposuction-obtained gluteal adipose tissue. A mixture of ADRCs and fibrin glue was subsequently transplanted into the fistula, and ADRCs were percutaneously and endoscopically injected around the fistula. We evaluated the safety and feasibility of ADRC transplantation and fistula closure in six patients (UMIN000007316).
RESULTS:
ADRC transplantation was completed in all patients. The fistula closure rates were 83.3 % at 4 and 12 weeks and 100 % at 24 weeks. All patients had grade 1 pain and subcutaneous hemorrhage at the liposuction sites, but no serious adverse events related to this procedure were observed.
CONCLUSIONS:
Transplantation of autologous ADRCs is safe, feasible and advantageous, as it can secure a sufficient cell count without culture or multiple passages, and will likely be effective for a postoperative enterocutaneous fistula.



Just as a reminder.... Calhoun once told me that the closure rates on past fistula clinical experience was around 65-70% after 1 year i.e. closure without relapse. Tigenix which just had its phase III in Europe completed was very similar. :nice:

This however beats all..... if can be repeated in a higher N.

Please Log in or Create an account to join the conversation.

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:

Results of enterocutaneous fistula study published 29 Oct 2015 19:52 #5371

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 377
  • Thank you received: 196
For any other stock this news would have been a catalyst for a significant PPS movement. That it did not speaks volumes about how far under the radar this stock is. Yes, the failure of management to progress this technology is tragic, but the data is positive and we should not loose sight of this.

This quote is very important and has not been given the requisite attention :

"The study builds on prior reports using Cytori Cell Therapy™ in a different kind of enterocutaneous fistula (fistula-in-ano) published by Dr. David Borowski and collaborators at North Tees Hospital in the United Kingdom in the journal “Surgical Innovation”. A follow on European physician initiated trial for patients with fistula-in-ano is planned to begin enrollment later in 2015. More details can be found on clinicaltrials.gov (NCT02558543) and the company will provide updates as appropriate."

Given the (1) prior approval in Europe for rectal and vaginal fistulas on the basis of the Olympus trial, (2) Borowski's positive initial trial in enterocutaneous fistula (fistula-in-ano), (3) the positive enterocutaneous Japanese trial and (4) assorted trials in PAD and wounds: if large enough this trial could conceivably be of registration quality given that it is for an indication which is not easily treated and is extremely expensive for national health care systems. This is an indication where the cost/benefit ratio may finally be in our favour. :yep: Thoughts?

The lack of disclosure by Olympus of the fistula data is criminal. Personally I cannot understand how it has not been disclosed given that it was submitted to the european national health authorities for review and approval. This failure to disclose is unprecedented. :bash: If I was a patient and found a physician to undertake this procedure (self-pay) I would want to to know the data on which the approval was based. I assume that the physician undertaking this procedure should also be entitled to know the data also. Surely some form of freedom of information law exists that would make disclosure possible? The fact that Olympus has chosen not to disclose or commercialize this procedure is strange to say the least. Question: can I have the procedure done given that it is approved, if I am prepared to pay for it? Question: On what basis can Olympus prevent me from accessing this procedure? Question: If they can prevent it , for how long? Has Cytori given up this indication indefinitely and why is there not a non-performance clause enacted for Olympus' lack of marketing activity? Why doesn't CYTX buy back the right to this indication. Enquiring minds want to know :evil:

There are any number of trials going on in Japan at this moment, case in point being the enterocutaneous fistula trial. Given the new more friendly legislation in Japan it beggars belief that there is no movement by Olympus/Cytori to submit the european data to the Japanese authorities and submit an application for a local confirmatory trial. Surely something is happening along these lines?
If not ...... Why not? :bash:

There is so much potential here to radically change the cost basis of health care that I can understand the necessity of doing this right , I can also appreciate the range of competitors who are/will be affected by the broad acceptance of this technology. What I find hard to accept is the reticence of our "partners" to drive this technology forward ......... Olympus ...... Astellas ....... :cry:

Would be nice to know what Lorem is doing in China, Singapore, Malaysia, Australia etc with these indications. China is a huge self pay market that should be able to generate sales for these hard to treat indications. How about some news please?

Please Log in or Create an account to join the conversation.

Results of enterocutaneous fistula study published 30 Oct 2015 00:01 #5372

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2765
  • Thank you received: 199
rongside
The first 3/4 of your post has one answer imho: Calhoun !

***radically change the cost basis of health care***
Although it has had absolutely no effect on the PPS the environment in the USA is beginning to recognize the need for this and should bode well for CYTX in the future... assuming we get something to market.

***Olympus ...... Astellas ***

LOL :grin:

At least Olympus had the foresight to sell not only its stock but its joint venture partnership rights back to CYTX.
Does Astellas ever get off the pot ? Unknown !


***Would be nice to know what Lorem is doing in China, Singapore, Malaysia, Australia***
Last heard muttering to himself where is he going to store all these Celutions he will be forced to buy....LOL
####################

Will our mystery app be able to be funded ?
November was supposed to be decision/disclosure time.
I still say scleroderma update the biggest factor this call....that funds much if taken to completion and expected market is really there.

Please Log in or Create an account to join the conversation.

Results of enterocutaneous fistula study published 31 Oct 2015 00:03 #5373

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 377
  • Thank you received: 196
Hedge: Agreed, Calhoun was a disaster. If he had chosen fistula instead of tits we would be golden. :cry:

Olympus chose fistula and got European approval with what we can only assume was conclusively positive data. Given we have bought back the joint venture partnership and Olympus has sold its shareholding surely we are entitled to the data that led to approval. :KO: What could possibly be the basis for withholding it on the part of Olympus? .......... or CYTX ............Something is going on here ....................

My point is that the existing European approval plus the latest Japanese data for enterocutaneous fistula should provide the basis for a Japanese fast track registration proposal by CYTX. Given the severity, cost of treatment and lack of alternatives for this condition perhaps a non randomised open label trial treating intractable fistulas that have failed current state of care could be used? Is it not possible (even rational) to expect that fistula is the "mystery app? :winky:

As for China, the size of the market is such that just the fistula indication should be enough to make CYTX fly. Of course doctors need trial data in order to tryout the device. Reinventing the wheel is such a stupid waste of time. Someone has a lot to answer for. I want to know why this data has yet to be disclosed.

Please Log in or Create an account to join the conversation.

Results of enterocutaneous fistula study published 31 Oct 2015 02:49 #5374

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2765
  • Thank you received: 199
***possible (even rational) to expect that fistula is the "mystery app***

Yep, given our last press release I believe it is very possible. Will it be funded is the real question ?

China is a long road imho.

Please Log in or Create an account to join the conversation.

Results of enterocutaneous fistula study published 01 Nov 2015 11:51 #5383

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3298
  • Thank you received: 1110
Couple of comments- but as one could guess, i CONCUR WITH VIRTUALLY EVERYTHING RONGSIDE WROTE :whistle:

"

The study builds on prior reports using Cytori Cell Therapy™ in a different kind of enterocutaneous fistula (fistula-in-ano) published by Dr. David Borowski and collaborators at North Tees Hospital in the United Kingdom in the journal “Surgical Innovation”. A follow on European physician initiated trial for patients with fistula-in-ano is planned to begin enrollment later in 2015. More details can be found on clinicaltrials.gov (NCT02558543) and the company will provide updates as appropriate."


The referenced NCT number is the scleroderma clinic and not "A follow on European physician initiated trial for patients with fistula-in-ano is planned to begin enrollment later in 2015"- I find this sloppiness, highly annoying. :puke:

This is an indication where the cost/benefit ratio may finally be in our favour. :yep: Thoughts?


Absolutely- I had this case report from Spain on this site for ages and it tells exactly how intensive and expensive this terrible disorder can be..

File Attachment:

File Name: Case-Report-crohnsfistula.pdf
File Size: 958 KB

There are any number of trials going on in Japan at this moment, case in point being the enterocutaneous fistula trial. Given the new more friendly legislation in Japan it beggars belief that there is no movement by Olympus/Cytori to submit the european data to the Japanese authorities and submit an application for a local confirmatory trial. Surely something is happening along these lines?
If not ...... Why not? :bash:


Yes- absolutely. Olympus is one of the names in the regenerative field also thru the Olympus-Terumo JV and the 6 patients could serve as "evidence" it works on Japanese patients too... :whistle: :grin: Lots of mysteries surrounding Olympus and Astellas.... :write:
Attachments:

Please Log in or Create an account to join the conversation.

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:
  • Page:
  • 1
Time to create page: 0.128 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites