× Adult Stem Cell News and Developments other than Cytori

FDA knows abou Fistula

16 Jun 2017 08:36 #9476 by rongside
Interesting article about a severe case of fistula in the lung. The FDA gave compassionate approval for a single patient trial to take place.
We know Tigenix is working on this indictaion. Surely CYTX should/could be gearing up for trials in this indication (fistula generall). We have a wide range of trials with positive results in both fistula and wounds that warrant our involvement.

www.statnews.com/2016/06/24/belly-fat-stem-cells-lung-cancer/

Lets hope that scleroderma approval is the catalyst tha brings forward interested parties that will partner with us in taking this technlogy forward.

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18 Jun 2017 06:27 - 18 Jun 2017 06:29 #9484 by fas

rongside wrote: Interesting article about a severe case of fistula in the lung. The FDA gave compassionate approval for a single patient trial to take place.
We know Tigenix is working on this indictaion. Surely CYTX should/could be gearing up for trials in this indication (fistula generall). We have a wide range of trials with positive results in both fistula and wounds that warrant our involvement.

www.statnews.com/2016/06/24/belly-fat-stem-cells-lung-cancer/

Lets hope that scleroderma approval is the catalyst tha brings forward interested parties that will partner with us in taking this technlogy forward.


Yeah- I think you are right John. Especially the rectal- and vaginal fistulae (which are the most common ones) would qualify for the general condition of the application to be a blood flow restricted part of the body.
As we know- Cytori has already added device claims approval in the UK for fistula after Crohn´s and for the regular gastro-intestinal fistula, but somehow I think that all was a waste of time, since Olympus will hog the data and will not support an EMA approval process.

So- we will have to rely on the folks in Marseille again, as was with scleroderma. As Cytori reported in 2015, a small clinic should be completed early 2018 for fistula after Crohn´s at Assistance Publique Hopitaux De Marseille, which surely will be done in the proper fashion and could lead up to an approved application despite Takeda and the approved Tigenix app.

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


Link- HERE

by the way- the clinic in Marseille is very active in several apps that we both know from the past, that would be good indications for ADRCs. Diabetic ulcer and vocal cord being just two of them.:winky:

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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19 Jun 2017 08:02 #9486 by rongside
Fas, here is some preliminary data from the Marseille 10 patient fistula trial.

Looks promising, but still early days. :nice: Hope the data analysis provides an insight into designing a better trial protocol.

www.ecco-ibd.eu/index.php/publications/congress-abstract-s/abstracts-2017/item/op008-an-innovative-treatment-for-refractory-perianal-fistulas-in-crohn-s-disease-local-micro-reinjection-of-autologous-fat-and-adipose-derived-stromal-vascular-fraction.html?category_id=483

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19 Jun 2017 10:20 #9487 by fas
Thanks John,

That looks pretty decent- everything at this stage- statistically significant. If the full closure rate at 48 weeks moves to 70% or so, it will be top of league.

In due course, we should re-visit the Tigenix results again to compare, but that can wait for now. If I re-call correctly, their primary endpoint was against standard of care, which to me is always suspect, when one speaks of an "unmet need".

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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