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TOPIC: "New" Fistula Trial in Marseille

"New" Fistula Trial in Marseille 19 Jan 2016 06:25 #6043

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Enrollment Begun on Phase II Clinical Trial in Crohn’s Disease

01/19/2016

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today enrollment of the first two patients in an investigator-initiated clinical trial of Cytori Cell Therapy™ for the treatment of the orphan indication, fistula-in-ano associated with Crohn’s Disease.

This 10 patient open label trial is being performed by Professor Jean-Charles Grimaud and colleagues at the Hôpital Nord, Marseille, France under the authority of the Agence Nationale de Sécurité du Médicament (ANSM), the French equivalent of the US Food and Drug Administration (FDA). As with the SCLERADEC I trial of Cytori Cell Therapy performed by a different group in Marseille, this trial is being executed in an indication that has been recognized as orphan by both the European Medicines Agency and the US FDA.

“This trial continues and expands the use of Cytori Cell Therapy in strategic niche indications such as orphan diseases. When coupled with the previously published trial data in fistula repair from Japan and the United Kingdom this trial could provide the basis for a follow-on sponsored clinical trial as part of a formal clinical development program,” said Dr. Steven Kesten, Chief Medical Officer at Cytori.

Fistula-in-ano is an abnormal tunnel linking the interior of the lower intestine to the skin adjacent to the anus such that the contents of the intestines can leak through by-passing the anal sphincter. They are associated with substantial pain, risk of infection, and reduced quality of life. 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.

The approach taken by Prof. Grimaud combines placement of a mixed cell/tissue product into the tissue surrounding the fistula while placing additional therapeutic cells within the fistula itself. Prof. Grimaud has considerable experience in this field with several published studies in the surgical management of fistula in patients with Crohn’s disease.

This trial builds on prior reports using Cytori Cell Therapy in fistula repair published by Mr. David Borowski and collaborators at North Tees Hospital in the United Kingdom and, most recently, by Professor Masaki Mori at Osaka University Graduate School of Medicine in Osaka, Japan. Links to further information about these studies are copied below.

www.ncbi.nlm.nih.gov/pubmed/25710946
www.ncbi.nlm.nih.gov/pubmed/23144344
www.ncbi.nlm.nih.gov/pubmed/26342817

Further details on Prof. Grimaud’s trial can be found at: clinicaltrials.gov/ct2/show/NCT02520843


And the carousel goes round and round and round... :whistle: :whistle:

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"New" Fistula Trial in Marseille 19 Jan 2016 07:22 #6045

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Note to Holdi- I deleted your topic Holdi, since Cytori used an "incorrect and misleading" title for the news.This therapy is against fistula after Crohn´s disease (about 25% of Crohn´s sufferers develop a fistula) and NOT against Crohn´s itself which is a horrible debilitating auto- immune disorder.

The record at Clinicaltrials.gov is interesting

Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". .
Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas.
Adipose tissue seems to be an ideal source for cell therapy. This is a prospective, open, non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and will be conducted over a period of 28 month.
This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, the safety and efficacy of local microinjection of autologous adipose tissue and SVF from microaspirate .
The main objective is to assess tolerance and security. The secondary objective is to evaluate the effectiveness of this technique
Condition Intervention Phase : Crohn Disease, Drug: stromal vascular fraction (SVF), Phase 1 Phase 2
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study : Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title: An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and Stromal Vascular Fraction
Further study details as provided by Assistance Publique Hopitaux De Marseille:
Primary Outcome Measures:
efficacy (measured as an absence of purulent collections superior to 2 cms concerning the fistula measured clinically and by MRI) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample (hemogram , coagulation factors) and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate effectiveness of treatment. The efficacy of treatment is measured as an absence of purulent collections superior to 2 cms concerning the fistula treated at 12 and 48 weeks measured clinically and by MRI
safety (measured by an absence of fever and local inflammatories symptoms) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample (hemogram and coagulation factors) and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate tolerance of treatment. The safety is measured by an absence of fever and local inflammatories symptoms measured at week 1, 2,8, 16 and 48
Secondary Outcome Measures:
improvement of quality of life (assessed by questionnaire) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Quality of life is assessed by questionnaire concerning (Inflammatory Bowel Disease) (SIBDQ: Short Inflammatory Bowel Disease Questionnaire) at week 2, 12, 16 et 48
Estimated Enrollment: 10
Study Start Date: October 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crohn's disease treated by SVF
Patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, treated by Stromal Vascular Fraction ( SVF) reinjection
Drug: stromal vascular fraction (SVF)
stromal vascular fraction (SVF) is administered to the patient suffering of Refractory Crohn's disease around of the fistula by local mico injection
Detailed Description:
Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". Anoperineal lesions are a very frequent entity in this disease (20 to 80%) and a real therapeutic challenge. Among these lesions, we were interested in fistula-in-ano that are currently difficult to treat despite a large therapeutic arsenal.
Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas.
Indeed, stem cells have shown some efficacy in several indications through their differentiation potential, including fistula-in-ano in Crohn's disease.Adipose tissue seems to be an ideal source for cell therapy This is a prospective, open, non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and will be conducted over a period of 28 month. This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, the safety and efficacy of local microinjection of autologous adipose tissue and SVF from microaspirate.
The main objective is to assess tolerance and security. The secondary objective is to evaluate the effectiveness of this technique Microaspiration is performed by a plastic surgeon under general anesthesia. He performs two types of fat removal : a sample of 120 cc wich is sent to the laboratory of cell therapy to obtain the SVF (5 cc) and a sample of 30 cc.
Once treatment obtained (SVF + adipose tissue) it is administered to the patient by local mico reinjection into (SVF) and around (adipose tissue) of the fistula. This administration is made by the surgeon under a second general anesthesia after viewing the fistula and removal of setons. Then the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate tolerance and effectiveness of treatment. At the end of the study, results that are expected are effectiveness of local micro reinjection of autologous adipose tissue and SVF for the treatment of refractory fistula-in-ano in Crohn's disease.
Contacts
Contact: Jean-Charles GRIMAUD, MD +33491668739 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Alexandra GIULIANI +33491382870 This email address is being protected from spambots. You need JavaScript enabled to view it.
Locations France Assistance Publique Hopitaux de Marseille Recruiting Marseille, France, 13354
Principal Investigator: Jean-Charles GRIMAUD, MD Assistance Publique Hopitaux De Marseille
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"New" Fistula Trial in Marseille 19 Jan 2016 08:03 #6046

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This move by the doctors in Marseille is very interesting, especially since Tigenix recently announced the results of its Cx601 clinic for perianal fistula´s after Crohn´s which were statistically significant and therefore most likely will receive EMA approval and already has the quoted "orphan indication" from the EMA.

To me perianal fistula´s are the same thing as fistula-in-ano- no difference to my knowledge. :whistle:

Anyway- no harm done- all PI stuff and to be honest, the Tigenix results did NOT impress me as Tigenix shareholder even if they were hailed as the first clinical proof that stem cells work... :grin: :grin: and were clinically proven. :cool:

Here the write-up on Cx601, which is in process of being approved by the EMA for perianal fistula´s after Crohn´s

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) intra-lesionally injected. Cx601 is being developed for the treatment of complex perianal fistulas in Crohn’s disease patients. Crohn’s disease is a chronic inflammatory disease of the intestine and patients can suffer from complex perianal fistulas for which there is currently no effective treatment. In 2009, the European Commission granted Cx601 orphan designation for the treatment of anal fistulas, recognising the debilitating nature of the disease and the lack of treatment options. Based on positive Phase II results, TiGenix sought scientific advice from the European Medicines Agency (EMA) on the future development path of Cx601. TiGenix then initiated a randomised, double-blind, placebo-controlled Phase III trial in Europe and Israel designed to comply with the requirements laid down by the EMA. ‘Madrid Network’, an organisation within the Autonomous Region of Madrid which helps companies to grow through high-technology innovation, issued a soft loan to help finance this Phase III study. The programme is funded by The Secretary of State for Research, Development and Innovation (Ministry of Economy and Competitiveness) within the framework of the INNTEGRA plan.
The study primary endpoint is combined remission, defined as clinical assessment at week 24 of closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections >2cm confirmed by MRI. The trial has a first complete analysis of results at 24 weeks, with a follow-up analysis to be performed at 52 weeks post-treatment. Recruitment of the whole sample of patients was completed in the fourth quarter of 2014. Based on the positive Phase III results, TiGenix will submit a Marketing Authorisation Application to EMA early 2016. TiGenix is preparing to develop Cx601 for the US market after having obtained FDA’s endorsement of its pivotal Phase III trial through SPA on the 7th of August 2015.

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"New" Fistula Trial in Marseille 19 Jan 2016 09:03 #6047

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ok.

Good news.

holdi

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"New" Fistula Trial in Marseille 19 Jan 2016 12:29 #6050

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Fas,
As a former headline writer, I think I'd have opted for Crohn's Patients in the headline... particularly as opposed to fistula in the behind.
The lead certainly is clear and accurate.

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"New" Fistula Trial in Marseille 19 Jan 2016 12:50 #6052

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Joncon63 wrote: Fas,
As a former headline writer, I think I'd have opted for Crohn's Patients in the headline... particularly as opposed to fistula in the behind.
The lead certainly is clear and accurate.


In view of the market reaction- the headline was kind of indifferent I would say.

Anyway- it the same thing as the last headline of the paper on the Japanese fistula work done. There it was ulcerative colitis if I remember correctly.

Both do not convey the truth- as a Company with an extremely bad reputation in keeping its "promises", Cytori should do its utmost in not portraying a "fall back" to the dark days of NOT conveying the truth.

But - I guess I know, why Hedrick is doing this- he does not want to lead folks back to the device approval he already has for "anal- and vaginal fistula after Crohn´s" from the UK Competent Authority. You wonder, why they are going for it "again"... :grin: :grin: :KO: :bash: :bang:
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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:

"New" Fistula Trial in Marseille 19 Jan 2016 14:21 #6053

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Joncon63 wrote: Fas,
As a former headline writer, I think I'd have opted for Crohn's Patients in the headline... particularly as opposed to fistula in the behind.
The lead certainly is clear and accurate.



Looking through the history of Cytori, i see no correlation with press releases and the spike to $9.50 a few years back. So much for headlines. :KO:

I think Cytori could even release a headline that says stem cells derived from adipose fat decrease cancerous tumors by 50% and the stock price still wouldn't budge. People want to see revenue. People want to see profit.

BUT I STILL BELIEVE!

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"New" Fistula Trial in Marseille 20 Jan 2016 09:35 #6058

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People want to see revenue. People want to see profit


What needs to be demonstrated is that an indication is proved to be mitigated by the introduction of ADRC cells that have been processed using the proprietary devices that Cytori has patented. Simple as that. And as complicated as that. Investigating that indication and focusing on proving the efficacy of the process for that indication should have been the sole purpose of management. They have failed in that pursuit and the hundreds of millions of dollars wasted are the ashes of what comprise the company at this point in time.

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"New" Fistula Trial in Marseille 20 Jan 2016 10:19 #6059

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fatboy wrote:

People want to see revenue. People want to see profit


What needs to be demonstrated is that an indication is proved to be mitigated by the introduction of ADRC cells that have been processed using the proprietary devices that Cytori has patented. Simple as that. And as complicated as that. Investigating that indication and focusing on proving the efficacy of the process for that indication should have been the sole purpose of management. They have failed in that pursuit and the hundreds of millions of dollars wasted are the ashes of what comprise the company at this point in time.


It's been proven but with naysaying paid guns like Adam Feustein derailing any rallies.... maybe the Board should invite him for a sit down interview and hire him as a "consultant". lol.

Too bad Vetstem isn't a public company. 3 people have mentioned vetstem to me in just the last few weeks.

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"New" Fistula Trial in Marseille 20 Jan 2016 11:43 #6060

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fas wrote: Both do not convey the truth- as a Company with an extremely bad reputation in keeping its "promises", Cytori should do its utmost in not portraying a "fall back" to the dark days of NOT conveying the truth.

But - I guess I know, why Hedrick is doing this- he does not want to lead folks back to the device approval he already has for "anal- and vaginal fistula after Crohn´s" from the UK Competent Authority. You wonder, why they are going for it "again"... :grin: :grin: :KO: :bash: :bang:



No wonder "they" call stem cell industry the biggest scam since Y2K (well, it started around the same time)... :evil:

Anyway, my point exactly... They keep repeating, and (I think) wondering that the newbies have an excuse for falling for it, but what is the old timers excuse! :whistle:

And they might say... Screw them, those greedy bastards for wanting to make so much money taking this baby from a dime to 1000 $ :grin:

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"New" Fistula Trial in Marseille 09 Feb 2016 00:18 #6259

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I am not too greedy. I would be happy at this stage to see the dime turn to $3.

The Marseille trial will take some time no doubt to provide us with some data.

Perhaps the following trial will do so earlier.

www.trialdetails.com/detail/NCT02628522/A-Novel-Method-for-Chronic-Anal-Fissure-Treatment

www.clinicaltrials.gov/ct2/show/NCT02628522?term=Andjelkov&rank=2

How can one give an approval to TIGENIX and not to CYTORI for this indication?

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"New" Fistula Trial in Marseille 09 Feb 2016 06:31 #6262

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Re the Serbian study, the results were published. Just found the reference in the IFATS program book. It's Paper presentation 86 on page 92.

www.ifats.org/wp-content/uploads/2015/11/IFATS-Program-Book-2015-Abstracts-11.2.15.pdf

Fas, I agree with you that the TIGENIX data is not so stellar. The success rate of 100% when using autologous ADRC is stellar. :woohoo:

One has to ask oneself why this treatment for the fistula indication is not being used extensively in Europe given they have the CE device approval? Surely the relative cost benefit in treating this indication warrants its being adopted quickly? :KO:

This indication should have had a dedicated phase III years ago.

The new Celution device is KEY.

HOW CAN A COMPANY WITH SUCH POTENTIAL HAVE PAINTED ITSELF IN SUCH A CORNER????
WHAT PREVENTS MAJOR COMPANIES FROM PARTNERING WITH CYTX???? :bash:

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"New" Fistula Trial in Marseille 09 Feb 2016 09:15 #6263

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rongside wrote: Re the Serbian study, the results were published. Just found the reference in the IFATS program book. It's Paper presentation 86 on page 92.

www.ifats.org/wp-content/uploads/2015/11/IFATS-Program-Book-2015-Abstracts-11.2.15.pdf

Fas, I agree with you that the TIGENIX data is not so stellar. The success rate of 100% when using autologous ADRC is stellar. :woohoo:

One has to ask oneself why this treatment for the fistula indication is not being used extensively in Europe given they have the CE device approval? Surely the relative cost benefit in treating this indication warrants its being adopted quickly? :KO:

This indication should have had a dedicated phase III years ago.

The new Celution device is KEY.

HOW CAN A COMPANY WITH SUCH POTENTIAL HAVE PAINTED ITSELF IN SUCH A CORNER????
WHAT PREVENTS MAJOR COMPANIES FROM PARTNERING WITH CYTX???? :bash:


Rong, you are looking at this from a wrong viewpoint...

The company cannot "thrive" in the current hole they are in. They simply are overextended and heavy... just like when someone with a 100k salary owes 300K in credit card debt.

If you look at the current situation, and assume you were the CEO, you would see the only way to survive is to tear it down and restart again... the shareholders are just unfortunate bystanders, that "are too greedy and want to make too much money", as wall street analysts called it.

Free American market way.

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"New" Fistula Trial in Marseille 09 Feb 2016 10:18 #6265

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cytxr wrote

the shareholders are just unfortunate bystanders, that "are too greedy and want to make too much money


Ha ha ha! A bit of humor never hurts. Thanks cytxr

Stem cells stem cells all the rage
Changing treatments stage by stage
Trial and trial each one with hope
That someone somewhere could be helped
All the holders held their breath
For news of progress on some front
In the end our hopes were taken
We bet on the fat but we got the bacon

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"New" Fistula Trial in Marseille 09 Feb 2016 19:59 #6269

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CYTXER. I don't disagree with the analogy of 100K salary and 300K credit card debt. What I would add to the equation is the mortgage-able assets of 2000K that they own. They insist on dealing with a payday cheque broker instead of with a reputable bank.

Just saying. Doesn't make sense !!@#%@

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"New" Fistula Trial in Marseille 09 Feb 2016 21:46 #6270

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Reputable banks don't deal with bozos ! LOL

Remember the stage was once packed with clowns at the annual meetings
Just because there are fewer of them doesn't mean the thinking has changed all that much

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"New" Fistula Trial in Marseille 10 Feb 2016 13:24 #6293

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fatboy wrote:
Stem cells stem cells all the rage
Changing treatments stage by stage
Trial and trial each one with hope
That someone somewhere could be helped
All the holders held their breath
For news of progress on some front
In the end our hopes were taken
We bet on the fat but we got the bacon



:cry: Memories, Nightmares, and Heartbreaks :cry:

If I could ever verbalize the disappointment this man caused me and my dear friends, I would write a book about it.

May I use this in a book? I will quote you of course, something like this would do? (odds are not favoring me finishing the book - FYI)

Stem cells stem cells all the rage
Changing treatments stage by stage
Trial and trial each one with hope
That someone somewhere could be helped
All the holders held their breath
For news of progress on some front
In the end our hopes were taken
We bet on the fat but we got the bacon

Fatboy, 2016?

:grin:

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"New" Fistula Trial in Marseille 10 Feb 2016 14:11 #6295

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May I use this in a book? I will quote you of course, something like this would do?


ctyxr,

By all means. I would be flattered to have a place in your book. I hope it is a comedy and not a tragedy!

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"New" Fistula Trial in Marseille 23 Mar 2016 05:21 #6688

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Although this thread was quite long, rather than start a new one I believe that the below mentioned single patient treatment is relevant to our "NEW" fistula trial.

The use of Celution in the below mentioned trial to treat the patient in Poland really was a "Hail Mary" attempt to save her life, It was successful. :nice:

www.ecco-ibd.eu/index.php/publications/congress-abstract-s/abstracts-2015/item/p406-adipose-derived-regenerative-cells-injection-as-a-novel-method-of-enterovesical-fistula-treatment-in-crohnaposs-disease-a-case-report.html?highlight=YToxOntpOjA7czo3OiJhZGlwb3NlIjt9

Also see the previously mentioned Serbian study data published in the latest IFATS program book: Paper presentation 86 on page 92. Six intractable fistula patients cured. :nice:

www.ifats.org/wp-content/uploads/2015/11/IFATS-Program-Book-2015-Abstracts-11.2.15.pdf

There have been multiple small trials undertaken in a variety of countries, in different hospitals and by different doctors . The fact that they have all been successful is a hugely positive indication of efficacy. The fact that they have not been double blind large studies does not make this data any less relevant. These are intractable fistula cases that have been cured ........ screw double blind. I hope the Japanese are fast tracking this ......... they should be .........

ADRC and Celution are amazing. What is truly amazing is that after receiving CE approval for use in the UK/EU so long ago this technology is still not being utilized. It is better than TIGENIX's treatment and certainly more cost effective. :bash: :KO:

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"New" Fistula Trial in Marseille 23 Mar 2016 07:27 #6691

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rongside wrote: ADRC and Celution are amazing. What is truly amazing is that after receiving CE approval for use in the UK/EU so long ago this technology is still not being utilized. It is better than TIGENIX's treatment and certainly more cost effective. :bash: :KO:


John- the amazing thing to me is that the ECCO- i.e. the European Crohn´s and Collitus Organisation does not know that we have EU approval as Cytori always told us... :whistle: and comes to conclusion at the end of the paper....

Conclusion
In our study for the very first time we managed to close the enterovesical fistula in critically-ill CD patient resistant to standard treatment, as traditional surgical approach was no longer appropriate. Further studies are needed to assess the safety and efficacy of the established method.]


maybe we have been had and Rothco is right is suing Cytori????

The whole abstract..

P406 Adipose derived regenerative cells injection as a novel method of enterovesical fistula treatment in Crohn's Disease: A case report
A. Moniuszko*1, A. Sarnowska2, W. Rogowski3, M. Durlik4, 5, G. Rydzewska1, 5

1Central Clinical Hospital of the Ministry of Internal Affairs, Department of Gastroenterology, Warsaw, Poland, 2Polish Academy of Sciences - Mossakowski Medical Research Center, Translative Platform for Regenerative Medicine, Warsaw, Poland, 3Central Clinical Hospital of the Ministry of Internal Affairs, Clinic of Urology and Oncological Urology, Warsaw, Poland, 4Central Clinical Hospital of the Ministry of Internal Affairs, Department of Gastroenterology and Transplant Surgery, Warsaw, Poland, 5Polish Academy of Sciences - Mossakowski Medical Research Center, Department of Surgical Research and Transplantology, Warsaw, Poland
Background
Up to date, the mesenchymal stromal cells (MSC) have been adapted in the treatment of fistulising Crohn`s disease with promising results. However, in most of the trials the MSC were obtained from healthy donors or needed long cultivation in laboratory environment.
Methods
A 52-year-old female, suffering from Crohn`s Disease for 12 years, did not achieve remission since the time of diagnosis, despite numerous treatments such as anti-TNFs and other non-standard therapies (i.e. tacrolimus or mycofenolate mofetil). The fistulising and penetrating subtype of the disease led to numerous laparotomies and several repositions of the ileostomy due to the formation of enterocutaneous fistula and lack of healing.

Patient was hospitalized with suspicion of urosepsis and symptoms suggestive of faecaluria. At the time two fistulas were present - enterocutaneous and perianal. The urine culture revealed severe polibacterial infection susceptible only to imipenem, however the targeted therapy did not lead to alleviation of the symptoms. The cystoscopy performed after oral application of methylene-blue colorant showed the presence of enterovesical fistula, approximately 3x1cm, with active suppuration of the intestinal content. As the patient was in critical state with signs of cachexia and had undergone numerous laparotomies, the standard surgical intervention was not considered.

After the acceptance of the Ethic Commitee, the injection of adipose derived regenerative cells (ADRC) into the enterovesical fistula was performed. Under general anaesthesia, a manual liposuction was carried out. 260 ml of lipoaspirate was immediately transferred into the CellCelution 800 system. After 2 hours, 5ml of ADRC suspended in Ringer solution was obtained.

During cystoscopy 4,5 ml solution containing 2,43*10^7 ADRC was injected through the needle routinely used for the botulin injections, in 0,5 mL portions around the fistula into the detrusor muscle. All procedure took 20 minutes. Obtained ADRC expressed in 99,5 ± 0.4% CD73, CD90 , CD105 and 9.0 ± 0,5% cells CD34, CD19, CD11b and HLA-DR surface markers.
Results
During the first 24 hours after the treatment patient suffered from temporal mild hypertension. No other AE were observed. Control cystoscopies after 2 and 3 weeks revealed complete healing of the fistula. During 5-month follow-up, the symptoms suggestive of enterovesical fistula did not recur.
Conclusion
In our study for the very first time we managed to close the enterovesical fistula in critically-ill CD patient resistant to standard treatment, as traditional surgical approach was no longer appropriate. Further studies are needed to assess the safety and efficacy of the established method.

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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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