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Posts Tagged ‘centeno’

The FDA vs Adult Stem Cells

In ALL ARTICLES on August 7, 2010 at 2:24 pm
A battle has been raging for quite some time without you even knowing it…

The FDA vs Adult Stem Cells


Adult stem cells have many supporters; many doctors, patients and scientists who want to see adult stem cells available in the US.  One of those supporters doing battle on the front lines is Chris Centeno, M.D. of Regenerative Sciences.  The FDA and Centeno have been doing battle for quite some time now…

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Feb, 11, 2009

Here is a letter from Chris Centeno, M.D. of Regenerative Sciences dated February 11, 2009 9:47:00 AM PST:

To set the record straight, the FDA sent us an “untitled” letter, not a warning letter. Their own information states that such a letter is to be sent when the FDA is unsure of it’s regulatory authority. We responded to this letter some 6 months ago and the FDA has not responded to our answers to their concerns.

We run a state of the art medical facility that has undergone a full, voluntary Reglera cGTP review and passed with flying colors. The medical procedure performed within our facilities compares very favorably with the ISSCR guidelines. While you bring up some interesting points, embryonic stem cell expansion is performed everyday in countless non-FDA regulated In-vitro Fertilization labs in the US, without issue. The practice of culture expanding autologous bone marrow cells to reconstitute the immune system of irradiated cancer patients is just beginning, again without FDA involvement and usually under the auspices of state regs.

Our procedure was first successful in a university based, large animal model. We spent a year porting that to human patients under the auspices of an Institutional Review Board (IRB).. We began treating commercial patients only after an additional year of IRB approved research (which continues). We don’t add new areas of treatment until after our research has shown imaging and patient reported evidence of efficacy and safety. As a concrete example, my initial interest as a pain management specialist was treating lumbar degenerative discs. However, just copying the successful animal model into humans didn’t work. It took three years of tweaking the procedure until we could get it to work reliably in a subset patients. Hence the procedure for discs wasn’t begun on commercial patients until recently and then only with specific inclusion criteria. As a result of these experiences of what will likely work and what won’t work, we categorize all patients as either GOOD, FAIR, or POOR candidates based on pathology. As an example, only about 25% of our joint patients are prospectively placed in the GOOD category, 50% in FAIR, and 25% in POOR.

We also employ a nurse to maintain a patient tracking database that is >3 years old and now contains 200+ patients, 50 or so of these have also had pre and multiple post-op 3.0T MRIʼs of the transplant sites. This safety data has been submitted for scientific publication. So while I donʼt dispute that like anything in medicine, practitioners can enter the field who may not be reputable (i.e. a surgeon who is not well trained or an IVF lab opening that doesnʼt do a good job of handling cells), we take our practice of medicine very seriously.

Chris Centeno, M.D.

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Aug. 6, 2010

I suppose it was inevitable that the FDA come after Regenerative Sciences. -dg

FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product


So, what was Regenerative Science’s response to this attack? -dg


Former President of Argentina, Dr. Fernando de la Rua, Visits Colorado Stem Cell Therapy Clinic – Technology | Centre Daily Times – State College, PA | Penn State, Nittany Lions, weather, news, jobs, homes, apartments, real estate

In STEM CELLS IN THE NEWS on July 13, 2010 at 11:23 pm

Former President of Argentina, Dr. Fernando de la Rua, Visits Colorado Stem Cell Therapy Clinic

Respected leader seeks to take innovative stem cell therapy to Latin America

July 13, 2010 6:31pm EDT

HOUSTON — While in Denver, CO, to participate in the Transnational Summit of Former Heads of State with twelve other former Presidents, current government officials, and dignitaries during the Biennial of the Americas, the former Argentinean President, Dr. Fernando de la Rua, made a special trip to Broomfield, CO, yesterday to visit a stem cell therapy clinic. The visit, coordinated by David Bonner, Chairman & CEO of Stematix™, Inc., allowed Dr. De la Rua to tour the Centeno-Schultz Clinic, meet with the doctors and observe the Regenexx™ procedure performed on several patients.

Dr. de la Rua, former President of Argentina, former Mayor of the City of Buenos Aires, and a distinguished law professor, visited the clinic in order to better understand stem cell therapy and speak directly to the patients who are benefiting from the regenerative procedure that uses a person’s own stem cells to repair joints, ligaments, bone and tendons.

“The development of progressive, state-of-the-art stem cell therapy clinics in Latin America is something that I am very interested in,” said Dr. de la Rua. “My visit to the Centeno-Schultz Clinic solidified my belief that the use of adult stem cells in stem cell therapies is of great benefit to the general population.”

Adult stem cells are those found throughout the patient’s own body. Recent medical research has indicated these important cells have as much clinical promise as the more controversial embryonic stem cells (cells taken from an embryo).

“The Regenexx™ Procedure, using a person’s own stem cells, is a breakthrough, non-surgical treatment option for people suffering from moderate to severe joint or bone pain due to injury and other conditions” said David Bonner, Ph.D., Chairman & CEO of Stematix™, Inc. “Because of the reduced risk and significantly shortened recovery time, stem cell therapy is an ideal option for individuals around the world.”

About Stematix™, Inc.

Stematix™, Inc. (Houston, USA) is a regenerative medicine delivery company whose goal is to make regenerative medicine products and treatments available to patients at reasonable cost and to international medical standards. Stematix is a licensee for the Regenexx Procedure in Latin America. Please visit the Stematix website (www.stematix.com) for more information.

via Former President of Argentina, Dr. Fernando de la Rua, Visits Colorado Stem Cell Therapy Clinic – Technology | Centre Daily Times – State College, PA | Penn State, Nittany Lions, weather, news, jobs, homes, apartments, real estate.

Patient Movement Forms in Opposition to FDA Position that the Patient’s Own Stem Cells are Drugs

In ALL ARTICLES, BEST OF THE BEST on April 9, 2009 at 11:42 pm

Patient Movement Forms in Opposition to FDA Position that the Patient’s Own Stem Cells are Drugs

A patient movement, called Safe Stem Cells NOW! was formed in response to the FDA’s position that the patient’s own adult stem cells are drugs and should be regulated as such. The patient group believes that this misclassification of adult stem cells will dramatically slow the availability of therapies without adding any significant patient safety.

At 71 years of age there is little interest on my part or anyone else’s to opt for lung transplants. I think this is disgraceful for our FDA to prohibit the use of autologous stem cells except in a very narrow concept so that people are forced to seek relief outside the USA

Broomfield, Colorado (PRWEB) April 9, 2009 — The American Stem Cell Therapy Association (ASTCA) announced today the on-line publication of its patient web-site, www.safestemcells.org, which reflects the activities and opinions of patients driving the Safe Stem Cells NOW! movement. The patient movement was formed in response to the FDA’s position that the patient’s own adult stem cells are drugs and should be regulated as such. The patient group believes that this misclassification of adult stem cells will dramatically slow the availability of therapies without adding any significant patient safety.

Adult stem cells in culture Adult stem cells in culture

Barbara Hanson, the co-founder of www.stemcellpioneers.com, stated “Adult stem cells are cells from our own body. They are very safe. There are no moral or ethical issues. They are safer than taking aspirin and yet the FDA has classified our own stem cells as drugs that require regulation. This means that prolonged investigations, including lengthy clinical trials, will be required for each and every disease and application that adult stem cells could be used for. This could take years and years. It smells of big pharma to me and many others.”

A critical initiative for the ASCTA and the Safe Stem Cells NOW! movement is to bring public awareness to the FDA’s position so consumers, and those who stand to benefit from safe stem cell therapies, have the opportunity to be heard. “We get letters and calls every day from people suffering from a variety of conditions and diseases that have no known cure who are eager to access stem cell therapies.”, Hanson adds. “Many of them are forced to look outside the U.S. for treatment, which involves prohibitive travel and procedure costs.”

One of those patients is Beverly Lessard, a 71-year-old patient from Florida, who has been diagnosed with end stage emphysema. Her late-stage condition prohibits extensive travel and the estimated cost of $12,000 to $50,000 is unaffordable. “At 71 years of age there is little interest on my part or anyone else’s to opt for lung transplants. I think this is disgraceful for our FDA to prohibit the use of autologous stem cells except in a very narrow concept so that people are forced to seek relief outside the USA,” wrote Lessard.

Adult stem cells are ready for early clinical use now and can be processed with the same techniques commonly used in existing in-vitro fertilization labs. “Classifying them as drugs will not add to patient safety, but it will delay treatment to patients who don’t have 1-2 years to wait, let alone 5-7 years,” stated Christopher J. Centeno, M.D., a founding physician member of ASCTA. “ASCTA has established lab guidelines which will allow the safe use of the patient’s own adult stem cells under the supervision of doctors,” continued Dr. Centeno.

Adult stem cells are different from embryonic stem cells. Adult stem cells are found in the human body in various tissues. In order to obtain enough to treat a condition or disease, they often need to be cultured, similar to today’s fertility treatments. Adult stem cells have undergone much more research than embryonic stem cells and thus are closer to real world treatments. These adult stem cells are taken from the patient’s own body (autologous) and ASCTA believes that they are therefore safest for use in treating patients.

About Safe Stem Cells Now!
The Safe Stem Cells NOW! Movement was started by the American Stem Cell Therapy Association and driven by its patient members. The movement’s goal is to inform patients and physicians that their ability to access safe stem cell treatment is being heavily restricted by pharmaceutical industry agendas and by the FDA. For more information, visit www.safestemcells.org.

About ASCTA
The ASCTA is a physician group comprised of various medical and surgical specialties whose goal is to bring safe stem cell therapy to patients by establishing laboratory and clinical guidelines. Christopher Centeno, M.D. is a board certified pain management specialist in Colorado who utilizes The Regenexx Procedure, an innovative adult stem cell therapy that helps patients avoid the need for more invasive orthopedic surgery. Dr. Centeno has published numerous medical research papers on the clinical application of adult mesenchymal stem cells. For more information, visit www.stemcelldocs.org.

MEDIA CONTACT:
Holly Hamann
media (at) stemcelldocs (dot) org

via Patient Movement Forms in Opposition to FDA Position that the Patient’s Own Stem Cells are Drugs.

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