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

TOPIC: Maranon study completed on Paralyzed Vocal Cord

Maranon study completed on Paralyzed Vocal Cord 11 Oct 2016 07:59 #7753

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3299
  • Thank you received: 1110
Old timers will remember Francisco Fernandez-Aviles (Paco) and Perez-Cano who were PI´s in clinical trials conducted by Cytori (PRECISE and RESTORE-2).
Both were of the Hospital General Universitario Gregorio Marañon in Madrid, from which now the completion of a clinical trial is reported on filling paralyzed Vocal cords with either auto fat or enriched fat.

Similar-very tiny- studies were also conducted in late 2009/10 in Japan and Glasgow and never heard of again. The sheer fact that Maranon decided to publish a study which started in 2012 and now was recently completed (18 patients) seem to indicate that development will continue.

The detailed description from the record:

This is the first Development Safety Update Report prepared for Phase I-IIA Clinical Trial- FIBHGM-ECNC007-2010 (PHASE I / IIA CLINICAL TRIAL, UNICENTRIC, RANDOMIZED, CONTROLLED, TWO PARALLEL-GROUPS, TO EVALUATE THE SAFETY OF A NEW THERAPY WITH STEM CELLS DERIVED FROM ADIPOSE TISSUE FOR GLOTTAL GAP IN THE UNILATERAL PARALYSIS OF THE VOCAL CORD in the International Conference on Harmonization (ICH) E2F format. This trial contains relevant safety information from the reporting interval of 08 July 2012 to 30 Sep 2014 This phase I / IIA clinical trial has been conducted to evaluate the safety of ADRCs. This new therapy is performed to induce the overexpression and production of microvessels in the paralyzed vocal cord, to permanently increase its volume and thus facilitate the GG closure. In paralysis of VC an increase of glottal gap occurs leading to dysphonia and aspiration of food, foreign bodies...

The creation of these new blood vessels, through the action of stem cells derived from adipose tissue, may produce a greater volume of the paralyzed vocal cord allowing GG closure more easily.

Patients included in this clinical trial require treatment for unilateral vocal cord paralysis. It has been considered regarding the authorised protocol that a glottal GAP requires intracordal injection to increase its volume when the glottal closure·during phonation is insufficient or there is lack of compensation to the contralateral vocal cord.

Patients are randomized to receive one of the following therapeutic strategies:

Group A: Autologous Fat processed by centrifugation to fill a paralyzed vocal cord, using the same.

Group B: Autologous Fat enriched with stem cells from adipose tissue to treat vocal cord paralysis.

Active control: Autologous fat tissue processed by centrifugation. Route of administration: Injection inside a paralyzed vocal cord.

Experimental drug: Stem cells from autologous adipose tissue in which autologous tissue is enriched or in suspension to fill the paralyzed vocal cord. The aim is to induce the overexpression and production of microvessels at local level. Route of administration: injection into the thickness of a paralyzed vocal cord.

In patients assigned to ADRC group therapy, two surgical interventions are performed on the same day, once randomized, at visit 0 according to the protocol. For the group assigned to the control (autologous adipose tissue), the therapy is performed in a single surgical intervention, once randomized, at visit 0 according to protocol.

The patients who are included will be followed for six months from the implant.


Link : HERE

Mind you- although Cytori or Celution is not mentioned any where- the clinic is 100% a Celution clinic. :grin:

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:

Maranon study completed on Paralyzed Vocal Cord 11 Oct 2016 19:28 #7755

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 789
  • Thank you received: 103
Fas, welcome back from northern Spain.

I went back and listened to the Rodman and Renshaw presentation. I wanted to refresh my memory regarding Hedrick's remarks re OA partnership talks. If he was serious in what he said, these talks may actually happen right now. Recently, CYTX amended the 2015 Annual Report. I am wondering if this may have anything with partnership ongoing DD or it may have to do with the new auditor.

CYTX has been totally silent newswise. Interesting indeed.

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

Maranon study completed on Paralyzed Vocal Cord 11 Oct 2016 20:11 #7756

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2768
  • Thank you received: 199
another failed post !

test test test

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

Maranon study completed on Paralyzed Vocal Cord 11 Oct 2016 20:14 #7757

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2768
  • Thank you received: 199
Com'on franshei,

Here is the reason for the 10K/A:
.EXPLANATORY NOTE
This Amendment No. 2 on Form 10-K/A (the “Amendment”) amends the Annual Report on Form 10-K of Cytori Therapeutics, Inc. (the “Company”) for the fiscal year ended December 31, 2015 (the “2015 Form 10-K)”, that was filed with the Securities and Exchange Commission on March 11, 2016.  The purpose of the Amendment is solely to correct a typographical error in the fiscal year-end date in Exhibit 32 of the 2015 Form 10-K.
The Company hereby amends and replaces Exhibit 32 of the 2015 Form 10-K in its entirety.  In addition, pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, the Amendment includes new certifications of our principal executive officer and principal financial officer on Exhibits 31.1 and 31.2, each as of the filing date of the Amendment.
Except as described above, no other amendments are being made to the 2015 Form 10-K. This Amendment does not reflect events occurring after the filing of our 2015 Form 10-K or modify or update the disclosure contained in the 2015 Form 10-K in any way, except as discussed above.
 
If there was even a remote interest from a OA partner at this time would we really be trading with record low post R/S volume ?
Let alone a PPS sub $2 again ?

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

Maranon study completed on Paralyzed Vocal Cord 12 Oct 2016 10:51 #7758

  • rodney.strongg
  • rodney.strongg's Avatar
  • Away
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1278
  • Thank you received: 18
"PPS sub $2 again"

Hedgefund, what's your thoughts on the large September orders at $2 that resulted in well over 500,000 shares being purchased at 2.00 and 2.01, with 80,000 left on the last day of Sept., but pulled after the quarter-end. :winky: :winky: :winky:

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

Maranon study completed on Paralyzed Vocal Cord 12 Oct 2016 11:01 #7760

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2768
  • Thank you received: 199
Could be anything from accumulation by someone to a naked short cover.

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

Maranon study completed on Paralyzed Vocal Cord 12 Oct 2016 11:04 #7761

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2768
  • Thank you received: 199
If you are looking for a positive spin....market maker shorted a bunch to fill order and now has it sub $2 to recoup the shares.

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

  • Page:
  • 1
Time to create page: 0.090 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