Welcome, Guest
Username: Password: Remember me
General
  • Page:
  • 1

TOPIC: Looks like our wait just got a little longer.Maxim

Looks like our wait just got a little longer.Maxim 03 Nov 2014 09:44 #2581

  • rothco619
  • rothco619's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 467
  • Thank you received: 67
The FDA has released new guidance for the use of products for cellular therapy. The new regulations are contained in Section 1271.15b of CFR21, titled "Human Cells, Tissues, and Cellular and Tissue-Based Products," known as HCT/Ps. The stated purpose is to establish practices and eligibility and prevent spread of diseases. The section requires providers to register with the FDA Center of Biologics Evaluation and Research and comply with regulations. Section 1271 gives several exceptions for products that are considered to have minimal changes to the cells or pose minimal risk. The exceptions to the regulations include: 1) autologous use, in which the HCT/P is removed and implanted back to the same individual; 2) implanting the HCT/P back to the “same individual within the same surgical procedure”; 3) the HCT/P cells have been “minimally manipulated” and remain in their “original form”; and 4) the risk of disease transmission is no different from surgical procedures.

Centrifugation is not specifically mentioned in the document. This point may be clarified in the final guidance, but until it is clarified, we are assuming it is permitted under the minimal manipulation rule. If centrifugation is not permitted, additional therapies would be required to register, and this would put pressure on "do it yourself" operators.

Cytori: Cytori’s adipose-derived stem and regenerative cells (ADRC) are made from cells that are taken from adipose tissue and then extracted through a process of washing, enzymatic digestion, and filtration. According to Section 1271, the “combination with another article” and use of collagenase would mean that ADRC requires registration with the FDA. As such, we believe Cytori will need to purse a BLA pathway for product indications.

Cesca Therapeutics: Cesca has bioprocess technologies that are used for both therapeutic development (SurgWerks) and biobanking (MarrowXpress System). These systems isolate and concentrate different types of bone marrow cells. This process does not use cell separation media or agents to fractionate the cells. This retains cells in their original form and would fit the definition of “minimally manipulated.” As such, we believe Cesca may pursue therapeutic approvals through a device pathway.
IntelliCell BioSciences: IntelliCell has developed an autologous product called stromal vascular fraction cells. This technology uses ultrasound, rather than enzymes or agents, to separate vascular cells from a sample of adipose tissue. It then transplants them back to the donor. This process seems to fit the definitions of “autologous” and “minimally manipulated.”
Conclusion. We see the new guidelines as a positive as regulators move to define what is manipulated and requires clinical trials through either device or biologic pathways.

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

Looks like our wait just got a little longer.Maxim 03 Nov 2014 11:26 #2582

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3295
  • Thank you received: 1110
As discussed before elsewhere on this board- the experts in the industry (which does not include Jason Kolbert)- conclude that the FDA i.e. CBER will force "everything" to go the BLA way i.e. will be "biological drugs", since centrifugation can change the properties of the cells and clearly go beyond cleaning and rinsing.

Since Cytori is already a device Company alas no 510K but the riskier Class 3 device forcing it to do PMA´s for every application, this is unlikely to happen to any "non-regulated" product/process going forward.

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: 0.083 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