Welcome, Guest
Username: Password: Remember me
Off Topic on Adult (=regenerative) cell technology, but very much related i.e. pills and drugs of which we do not know if they work
  • Page:
  • 1

TOPIC: Fecal Transplant

Fecal Transplant 02 Sep 2013 14:58 #822

  • myownhedgefund
  • myownhedgefund's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2728
  • Thank you received: 199
Really interesting with what is happening here in treating C-Diff and perhaps some other bowel issues.

A simple search can bring up lots of info on the treatment...New England Journal of Medicine, Nature, Wired magazine have all covered the treatment and studies...well really one double blind study done in Europe with impressive results.

Basically...you take donor stool from one person and transplant it into another person (after donor stool is cleared for other diseases) to re-populate the good living bacteria. So yes...kind of a cell type therapy. Living cells (bacteria) .....Now the really interesting part ...the back pedaling of the FDA !!! Read below:

www.medpagetoday.com/Gastroenterology/GeneralGastroenterology/40628


The total cost of the new treatment seems to run for as little as 4k and the patients is cured and home in as little as 2 days in some cases compared to sometimes months of expensive antibiotics. In some articles it appears there was a upswell from the medical community and patients. Here is another article on the subject.

www.nbcnews.com/health/fda-backs-away-new-fecal-transplant-rules-6C10370978

So maybe the FDA can be changed at times.
The following user(s) said Thank You: keysman

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

Fecal Transplant 03 Sep 2013 08:37 #823

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3255
  • Thank you received: 1108
Yes- the infamous poop discussion.

That was a big theme in the Cell therapy LinkedIn group also as you can imagine. Fact is simply- the FDA has now re-arranged the human cells and tissue regulation in such a way, that they catch virtually all "natural products" and they become a drug i.e. they may cost 500-1000 Mio to get passed the FDA.

Those are - the product has to be for homologous use (the same part of the body where it is taken from is repaired at a patient) or that it has a systemic metabolic impact (metabolic= some chemistry or repair function, which is basically every process in the body)

Only from a a first or second degree relative one could take its poop without it being a drug. Ridiculous- insane really.

See regulations below

a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:

(1) The HCT/P is minimally manipulated;

(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;

(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and

(4) Either:

(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or

(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:

(a ) Is for autologous use;

(b ) Is for allogeneic use in a first-degree or second-degree blood relative; or

(c ) Is for reproductive use.

The following user(s) said Thank You: keysman

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: 0.131 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