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TOPIC: CELLCORDES Trial In France

CELLCORDES Trial In France 09 Aug 2018 09:22 #12164

  • rodney.strongg
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Cytori reports publication of interim pilot data for cell therapy in vocal fold scarring - see release issued at 9:25am.

Given the current state of affairs at CYTX and the violent destruction of s/h value, this release is almost comical - let's hope for something much more profound on Tuesday.

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CELLCORDES Trial In France 09 Aug 2018 10:51 #12166

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Crumbs, they are throwing up anything that sticks. All of these trials mean very little until they start getting some approvals to produce revs.
Let’s up that the real trial ongoing in France has something positive to report soon.

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CELLCORDES Trial In France 09 Aug 2018 19:32 #12167

  • myownhedgefund
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Comical is right RS.
A press release on 1 patient showing stated improvement but not even able to show the quality of the improvement.
The market yawned as it should have showing a small loss for the day.
Cant wait for story telling time on Tuesday

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CELLCORDES Trial In France 10 Aug 2018 04:26 #12169

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Just to document this announcement- what follows is the press release. As a reminder probably- this isnt a new application. In actual fact back in 2008/9 - at the same time RESTORE was done in Europe- there was already a clinic in Glasgow on the app. I believe recently some work was done in Japan too- so who knows, maybe one of these things Girao was talking about at the year-end call in March of apps, which SH are not aware about or had any focus.

SAN DIEGO, Aug. 09, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced publication in the peer-reviewed journal, Stem Cell Research and Therapy, of “Autologous adipose-derived stromal vascular fraction and scarred vocal folds: first clinical case report.” This report describes preliminary data from the CELLCORDES trial of Cytori Cell Therapy™ (ADRCs) in patients with severe voice dysfunction due to scarring of the vocal fold (vocal cords).

The CELLCORDES trial is a fully-enrolled investigator-initiated pilot trial conducted using Cytori Cell Therapy. The trial is being performed by Investigators at the Department of Oto-Rhino-Laryngology and Head and Neck Surgery of Aix-Marseille University and the Cell Therapy Laboratory of La Conception University Hospital, both of Marseille, France. Additional details on the trial may be found at clinicaltrials.gov.

The reported index patient had severe vocal dysfunction persisting for four years following traditional surgery to treat chronic vocal fold lesions. Twelve months after single direct administration with 12 million ADRCs, the patient exhibited improvements in Vocal Handicap Index and other qualitative and quantitative measures of voice quality including: Hirano’s GRB scale (measuring vocal hoarseness, roughness, and breathiness), Jitter (a measure of uncontrolled variation in frequency of the voice), and vocal range. The authors noted that while the remaining seven patients treated in the CELLCORDES study have yet to complete 12-months of follow-up, no serious adverse events have been reported in any subject and no subject has reported worsening of vocal function. Furthermore, three are exhibiting “very good results (especially on the VHI)”.


Hedge- the paper had the main news- the patient had an improvement in the Voice Handicap Index decreasing from 75 to 9. You do not specifically write a whole peer reviewed paper unless you got something important to publish -so there you go.

The abstract-

Patients with scarred vocal folds (congenitally or following phonosurgery) are currently difficult to treat and present a dysphonia, often disabling in daily life. Several therapies are available on the market but the results of these are often disappointing. The autologous adipose-derived stromal vascular fraction (ADSVF) is recognized as an easily accessible source of cells with angiogenic, anti-inflammatory, immunomodulatory, and regenerative properties. We
present here the case of a 43-year-old woman who had a severe dysphonia associated with scarred vocal folds after a phonosurgery and was resistant to conventional medical and surgical treatments. She received a local administration of autologous ADSVF. The protocol involved, on the same day, adipose tissue extraction, ADSVF preparation, and then local injection (0.45ml of ADSVF in each vocal fold, for a total of 12.2 million ADSVF viable cells). No serious adverse events have been described. One year following the surgery, the laryngoscopic aspect and the majority of voice parameters had improved, in particular the Voice Handicap Index decreasing from 75 to 9. The perceptual analysis found the voice to be less hoarse and more stable, without breathiness. The case of this patient highlights the therapeutic potential of ADSVF for such applications (trial registration, ClinicalTrials.gov NCT02622464;
registered 4 December 2015).

In total there were 8 patients in the trial, which has not been updated at clinicaltrials.gov since 2016.

paper-

File Attachment:

File Name: 2018-vocalcord.pdf
File Size: 1,030 KB
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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:

CELLCORDES Trial In France 10 Aug 2018 04:55 #12170

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Just as a note-

Surely again, this is the result of the main four mechanisms of therapeutic action - i.e. blood flow (angiogenesis), modulation of immune system, anti-inflammatory and wound healing, but the main result of this all being reduction of scarring i.e. fibrosis similar to scleroderma, liver and heart disease, in case the cells can be delivered in such a way that they have sufficient time to do their therapeutic work.

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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:

CELLCORDES Trial In France 11 Aug 2018 06:46 #12171

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To further quantify what Fas posted the paper also said:
***(a shift in the total score of 18 points or greater is required to be clinically significant*** (This is for the VHI)...the other parameter pre and post values are also listed in the paper for those interested.
While I don't want to belittle the helping of even a single patient I still feel the report of "one" has little value as a overall assessment of the procedure.

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CELLCORDES Trial In France 11 Aug 2018 10:45 #12172

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myownhedgefund wrote: While I don't want to belittle the helping of even a single patient I still feel the report of "one" has little value as a overall assessment of the procedure.


I do agree with you in respect of what this paper will do to the short term "future" of CYTX PPS, but key thing in my view is that the scientists from Southern France thought it significant enough to warrant informing their peers of the impact CCT had on a non-responding patient of standard of care -BEFORE completing the whole clinic, which would trigger a paper too.. THEY thought it was important and valuable. We have seen the same thing with the Polish ALS patients- only 4 qualified for treatment and besides the paper we read, they will write another one on a single patient- meaning, they saw impacts (presumable positive) on the patient which their peers should know about.

Another one was the Danish ED clinic- works excellent - on all patients- if those patients are continent. To me still- the tech works if applied properly and Cytori has made significant blunders there in the past. Maybe Franshei and Rongside are right- if Cytori does not survive (and I still think they will) in the interest of patients world wide, the tech should fall in the hands of an organisation that can properly develop it and NOT in the hands of BP who probably wants to bury it, since it is most likely highly disruptive to their pills with significant side-effects.

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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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