This Is MS Multiple Sclerosis Knowledge & Support Community

The legal battle around your own stem cells as drugs (thus under the regulation of FDA) is being fought in court by Dr. Chris Centeno. Here is a post with a link to a free ebook he just released to educate everyone. They are asking for comments from patients.

http://stemcellpioneers.com/showthread.php?t=6067

There is going to be a Stem Cell Summit in Houston Oct 26-27
http://www.stemcellsummit.com/houston/agenda.html

This will mark the first public presentations by Celltex, based in Houston TX.
Dr Stanley Jones will be speaking, he started the adult stem cell bank in Houston http://celltexbank.com/
He had the treatment himself for crippling rheumatoid arthritis several years ago, and is still in complete remission.
As of Aug 2012 they have treated 180 people with their own adipose (fat-tissue)-derived stem cells, expanded to a dose of 600 million cells.
20 of these patients had MS, and by the end of Oct 2012 there will have been 30 with MS treated.
I was treated in May of 2012 and continue to do very well in my recovery from SPMS.
All of this is under IRB monitored trials, so the results will help establish the effectiveness of this.
Presently this is a patient funded trial, costing $28,000 for the treatment, plus your own travel costs.

If you can't afford this treatment, here is what to watch for:
The hope is that the FDA will not rule this expanded cell treatment is a drug, requiring years of trials before it can get to patients.
This ruling may be done by year end. If our own cells are not ruled a drug, Celltex will be able to move this treatment under insurance coverage more quickly, although I have no time estimate.
Finally granting access to an effective treatment for MS with no awful side effects.

Celltex To Initiate New Clinical Program As It Responds To FDA Letter
— FDA claims making identical copies of a person's own stem cells is manufacturing a drug -
By Celltex Therapeutics Corp.

Celltex Therapeutics Corp.
Last modified: 2012-10-01T20:20:30Z
Published: Monday, Oct. 1, 2012 - 1:20 pm
Copyright 2012 . All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
HOUSTON, Oct. 1, 2012 -- /PRNewswire/ -- Celltex Therapeutics Corp. announced today that it has received a letter, dated Sept. 24, 2012, from the U.S. Food and Drug Administration. The letter stated the agency's opinion that the process Celltex uses to multiply adult stem cells is subject to FDA regulation as biological drug manufacturing. The issue is a key one as stem cell therapy for patient care outside of an academic institution is a new frontier, yet there are a variety of technologies being used throughout the United States, often creating complex legal and regulatory questions.
David Eller, CEO and President of Celltex, stated:
Celltex makes identical copies of an individual's own stem cells and therefore should not be subject to FDA regulation as drugs. However, the FDA said our process causes the cells to be considered biological drugs and thus is subject to those regulations. We respectfully but firmly disagree with the FDA and intend to contest the agency's opinion within its administrative procedures. We are considering all options as we work with the agency toward a resolution.
FDA's letter also repeats its earlier observations from an April inspection of Celltex's laboratory. While Celltex provided detailed responses in April, May, June, July and August, now FDA tells us it needs more information. We will answer FDA's questions in whatever detail the agency requests."
We will meet FDA's requirements, no matter how high the hurdles may be, to ensure access to this technology. Celltex remains fully committed to advance the most promising new field in human health in decades — regenerative medicine. We also remain committed to doing so safely, and we will continue to comply with federal and state agency requirements.
As we work with the FDA, Celltex will continue to make advances on the frontier of regenerative medicine, and we expect to have several significant announcements in the coming weeks on these matters:
Celltex is preparing Investigational New Drug (IND) clinical trials focused on the effectiveness of adult autologous stem cells for specific conditions, such as multiple sclerosis, osteoarthritis and macular degeneration.
Enrollment in Celltex's current clinical trials has reached the goal of 200 patients who received their own stem cells from their physician-investigators. Data collection and analysis have commenced, and results are expected to be published in 2013. This will represent the largest, and potentially the most important, adult autologous mesenchymal stem cell study conducted in the United States.
"Celltex is committed to developing the promise of regenerative medicine into a reality for doctors and their patients," Mr. Eller said. "We sponsor clinical trials to better understand the therapeutic impact and monitor the safety of adult stem cell therapy, and we are confident that our research will help implement effective treatments for patients suffering from a variety of medical conditions."
For more information on Celltex Therapeutics Corporation and its staff please visit http://www.CelltexBank.com.
About Celltex
Celltex Therapeutics Corporation is a leader in providing services for the rapidly expanding field of regenerative medicine. Specifically, Celltex purifies, multiplies, and stores adult adipose-derived mesenchymal stem cells and rigorously follows the standards of good manufacturing practices for human cell laboratories. Celltex's laboratory currently holds more than fourteen patents protecting methodology and quality control. The Celltex process ensures extracted adult stem cells are separated, multiplied and stored without any genetic alteration or exposure to stimulants to alter the cells' natural multiplication ability. Celltex is currently researching new methods and technology for banking and stem cell treatment therapies to further the field of regenerative medicine and document the therapeutic impact of adult stem cell therapies on various medical conditions.
For more information contact: Celltex at 713.590.1000 For media inquiries contact: 512.763.2656
SOURCE Celltex Therapeutics Corp

Read more here: http://www.sacbee.com/2012/10/01/487153 ... rylink=cpy