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

TOPIC: A Glance at RELIEF

A Glance at RELIEF 18 Oct 2018 07:16 #12302

  • fas
  • fas's Avatar Topic Author
  • Online
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116
While waiting for the Cytori future to unfold, this is one of the clinics that could have a long-term impact on the financial health of CYTX, assuming they effectively can manouver to financial stability sometime in 2020. when most likely 2 or 3 products are launched on the market.

As indicated by Hedrick in the August call- location sites were being screened - the new Celution version ready for action and the protocol approved by BARDA. Since September 10 the study therefore is marked as "recruiting" by clinicaltrials.gov.

Link to study: HERE

A few things one can read are interesting- besides Cytori being the sponsor of the study, they also provide the Principal Investigator- in this case Marc Hedrick himself, which I believe is quite unusual, since normally a leading expert in the discipline is recruited for that. However Hedrick- if I re-call right, is a MD in dermatology and a former plastic- and cosmetic surgeon from UCLA. So- he should be in full control, which I believe was not the case with OA and STAR. Anyway- good to see, that Min Zhu is listed as contact person in the study- she is very capable and presumed discoverer of ADRC´s in 2001 and I thought she was one of the victims of the September 2017 re-organisation.

Anyway- although up to 10 burn centers were planned to be recruiting- only 2 are presently listed. What is most unusual to me- that a link to the detailed study protocol was provided, which provides interesting reading for the happy few- I went through it and was impressed. See attachment-


File Attachment:

File Name: RELIEF-protocol.pdf
File Size: 1,675 KB
Attachments:
The following user(s) said Thank You: b767cpt

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:

A Glance at RELIEF 18 Oct 2018 09:08 #12303

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1361
  • Thank you received: 19

fas wrote: While waiting for the Cytori future to unfold, this is one of the clinics that could have a long-term impact on the financial health of CYTX, assuming they effectively can manouver to financial stability sometime in 2020. when most likely 2 or 3 products are launched on the market.

As indicated by Hedrick in the August call- location sites were being screened - the new Celution version ready for action and the protocol approved by BARDA. Since September 10 the study therefore is marked as "recruiting" by clinicaltrials.gov.

Link to study: HERE

A few things one can read are interesting- besides Cytori being the sponsor of the study, they also provide the Principal Investigator- in this case Marc Hedrick himself, which I believe is quite unusual, since normally a leading expert in the discipline is recruited for that. However Hedrick- if I re-call right, is a MD in dermatology and a former plastic- and cosmetic surgeon from UCLA. So- he should be in full control, which I believe was not the case with OA and STAR. Anyway- good to see, that Min Zhu is listed as contact person in the study- she is very capable and presumed discoverer of ADRC´s in 2001 and I thought she was one of the victims of the September 2017 re-organisation.

Anyway- although up to 10 burn centers were planned to be recruiting- only 2 are presently listed. What is most unusual to me- that a link to the detailed study protocol was provided, which provides interesting reading for the happy few- I went through it and was impressed. See attachment-


File Attachment:

File Name: RELIEF-protocol.pdf
File Size: 1,675 KB

/

Fas, I wonder if it has ever happened before where the Sponsor of a Study has its CEO as the Principal Investigator - can't make this stuff up! :puke: :bash:

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

A Glance at RELIEF 18 Oct 2018 11:35 #12304

  • fas
  • fas's Avatar Topic Author
  • Online
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116

rodney.strongg wrote: Fas, I wonder if it has ever happened before where the Sponsor of a Study has its CEO as the Principal Investigator - can't make this stuff up! :puke: :bash:


I do not know- than again of the hundred thousands of studies conducted in the past 50 years, I know very few. I do like it- saves money and gives Hedrick full control over the study. On top of that- of course - the ultimate sponsor is BARDA and they have to approve every fart escaped from the gastro-intestinal tract of the study. :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:

A Glance at RELIEF 18 Oct 2018 14:08 #12305

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1361
  • Thank you received: 19

fas wrote:

rodney.strongg wrote: Fas, I wonder if it has ever happened before where the Sponsor of a Study has its CEO as the Principal Investigator - can't make this stuff up! :puke: :bash:


I do not know- than again of the hundred thousands of studies conducted in the past 50 years, I know very few. I do like it- saves money and gives Hedrick full control over the study. On top of that- of course - the ultimate sponsor is BARDA and they have to approve every fart escaped from the gastro-intestinal tract of the study. :grin:


While they may have saved some money, it would seem that independence credibility was compromised, although BARDA involvement may be the mitigating factor.

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

A Glance at RELIEF 19 Oct 2018 10:50 #12306

  • b767cpt
  • b767cpt's Avatar
  • Offline
  • Gold Boarder
  • Gold Boarder
  • Posts: 303
  • Thank you received: 4
Have to admit, seems very detailed but a lot of it’s beyond my limited medical understanding.
My question would be, how long will a study like this typically take to finish?
Thanks Fas

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

A Glance at RELIEF 20 Oct 2018 05:59 #12307

  • fas
  • fas's Avatar Topic Author
  • Online
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116

b767cpt wrote: Have to admit, seems very detailed but a lot of it’s beyond my limited medical understanding.
My question would be, how long will a study like this typically take to finish?
Thanks Fas


B7- the study details plan complete enrolment end July 19. That means 12 months follow-up for the last patient lasts until July end 2020, plus say 4 months accumulating the study results. That all sounds reasonable, so what one can expect. This is than the device pilot study for safety and efficacy. Before a pivotal study has been done- based on the pilot study- a(partial?) roll-out of Celutions across the country is already very well possible
The following user(s) said Thank You: b767cpt

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:
  • Page:
  • 1
Time to create page: 0.084 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