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TOPIC: Results of Pig Model of Urethral Injury published

Results of Pig Model of Urethral Injury published 10 Jun 2016 06:21 #7203

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An older pig study by the French in Marseille is now published.

Jun 10, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication in The Journal of Urology of a preclinical study applying Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori Cell Therapy in a large animal model of urethral injury.
The results show that delivery of the cell therapy product immediately after injury resulted in a >50% decrease in fibrotic scar tissue from 17% of total urethral surface area in the control to 7% in the treated group (p=0.05) 30 days following treatment. The study further reported that delaying delivery of the cell therapy product until 30 days after injury—a time at which urethral fibrosis was well-established—led to >10-fold decrease in injured surface area (from 13% of the urethra in the control group to 1% in the treated group; p<0.05) at 60 days after injury (30 days after treatment). ADRC-treatment was also associated with a statistically significant increase in the maximum pressure generated by the urethra, an important component of urinary sphincter function.
This study was led by Drs. Giles Karsenty and Romain Boissier of Aix-Marseille University in Marseille, France supported by the team of Pr. Florence Sabatier of the Cell Therapy Department of Hôpital de le Conception, Assistance Publique-Hôpitaux de Marseille.
“These now published findings support the use of either immediate or delayed application of Cytori Cell Therapy to help reduce injury and scarring,” said Dr. Marc Hedrick, President and CEO of Cytori. “This important safety and proof of concept preclinical study will be useful in forthcoming regulatory submissions in the US, Europe and Japan.”
Data from this preclinical study supported the company’s recently enrolled the STAR clinical trial, an FDA-approved, 88 patient, multi-center, randomized controlled Phase III trial of Cytori Cell Therapy for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma as well as the investigator-initiated, ADRESU urinary incontinence trial currently enrolling in Japan. A reduction in cutaneous fibrosis as measured by the modified Rodnan Skin Score (mRSS) of the hand was also noted in the previous published SCLERADEC I clinical trial.


Shows that third parties laid out quite a few dollars to progress the science and partially restored what Cytori Management had fucked up in the past.

Meaning: I still believe the healing and auto immune properties of SVF are more important than blood flow... thank you dear French folks. I will support your team at the European Championship in France this coming week. :grin: :grin:

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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:

Results of Pig Model of Urethral Injury published 10 Jun 2016 06:24 #7204

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The Abstract from PubMed:

2016 Jun 2. pii: S0022-5347(16)30555-9. doi: 10.1016/j.juro.2016.04.099. [Epub ahead of print]
Histologic and urodynamic effects of autologous stromal vascular fraction extracted from fat tissue with minimal ex vivo manipulation on a porcine model of intrinsic sphincter deficiency.
Boissier R1, Magalon J2, Sabatier F2, Veran J3, Giraudo L3, Giusiano S4, Garcia S5, Dignat-George F6, Arnaud L6, Magalon G7, Lechevallier E8, Berdah S9, Karsenty G8.
Author information
Abstract
PURPOSE:
To evaluate the healing abilities of autologous stem cell therapy (stromal vascular fraction - SVF) prepared from adipose tissue using an automated system without an ex vivo culture phase in a pig model of intrinsic sphincteric deficiency (ISD).
MATERIALS AND METHODS:
Fifteen pigs were subjected to endoscopic section of the urethral sphincter. Animals were then randomly assigned to three groups: controls without injection of SVF, "early injection" (EI) with injection of SVF on 2-3 days following the section, and "late injection" (LI) delivery of SVF 30 days following the injury. Extraction and injection of SVF were performed in a single procedure. The SVF was characterized by flow cytometry. The mesenchymal stem cell-like cells (MSC-like) were enumerated by clonogenicity assay (CFU-F). End points included histological assessment of the surface of the urethral injury (SUrI), urodynamically, the maximum urethral pressure (MUP).
RESULTS:
Flow cytometric analysis revealed a phenotype of MSC-like for 47.3% ±11.8% of SVF cells. CFU-F frequency was 1.3 to 6.6 per 100 SVF cells (1.3-6.6%). SVF injection was associated with a reduction of SUrI in EI and LI groups compared with respective controls (EI: 7% vs. 17%; p = 0.050 and LI: 1% vs. 13%; p = 0.029). On D30 after injection of SVF, MUP was significantly higher in the injected groups compared with the control group: 64% vs. 50% of D0 MUP (p = 0.04).
CONCLUSIONS:
These data demonstrated the ability of autologous SVF to improve the urethral healing process in a large animal model of intrinsic sphincteric deficiency.
Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
KEYWORDS:
Cell- and Tissue-Based Therapy; Stem cells; Stromal vascular fraction; Urinary incontinence

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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:

Results of Pig Model of Urethral Injury published 10 Jun 2016 10:43 #7208

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fas wrote: An older pig study by the French in Marseille is now published.

Jun 10, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication in The Journal of Urology of a preclinical study applying Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori Cell Therapy in a large animal model of urethral injury.
The results show that delivery of the cell therapy product immediately after injury resulted in a >50% decrease in fibrotic scar tissue from 17% of total urethral surface area in the control to 7% in the treated group (p=0.05) 30 days following treatment. The study further reported that delaying delivery of the cell therapy product until 30 days after injury—a time at which urethral fibrosis was well-established—led to >10-fold decrease in injured surface area (from 13% of the urethra in the control group to 1% in the treated group; p<0.05) at 60 days after injury (30 days after treatment). ADRC-treatment was also associated with a statistically significant increase in the maximum pressure generated by the urethra, an important component of urinary sphincter function.
This study was led by Drs. Giles Karsenty and Romain Boissier of Aix-Marseille University in Marseille, France supported by the team of Pr. Florence Sabatier of the Cell Therapy Department of Hôpital de le Conception, Assistance Publique-Hôpitaux de Marseille.
“These now published findings support the use of either immediate or delayed application of Cytori Cell Therapy to help reduce injury and scarring,” said Dr. Marc Hedrick, President and CEO of Cytori. “This important safety and proof of concept preclinical study will be useful in forthcoming regulatory submissions in the US, Europe and Japan.”
Data from this preclinical study supported the company’s recently enrolled the STAR clinical trial, an FDA-approved, 88 patient, multi-center, randomized controlled Phase III trial of Cytori Cell Therapy for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma as well as the investigator-initiated, ADRESU urinary incontinence trial currently enrolling in Japan. A reduction in cutaneous fibrosis as measured by the modified Rodnan Skin Score (mRSS) of the hand was also noted in the previous published SCLERADEC I clinical trial.


Shows that third parties laid out quite a few dollars to progress the science and partially restored what Cytori Management had fucked up in the past.

Meaning: I still believe the healing and auto immune properties of SVF are more important than blood flow... thank you dear French folks. I will support your team at the European Championship in France this coming week. :grin: :grin:


Excited for the Russia vs. England match Saturday. Since I'm Irish , I'm going Russia.

I still believe one day, Cytori banner ads will line the World Cup stadium.

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Results of Pig Model of Urethral Injury published 10 Jun 2016 12:25 #7210

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Piggy news isn't what we need now....surely they are scraping the bottom of the PR barrel.

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Results of Pig Model of Urethral Injury published 10 Jun 2016 12:26 #7211

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Hedge, exactly correct but you gotta work with what you got!

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