May 25, 2013

The FDA has declared your own stem cells a drug. What you can do about it.

Hopefully you are aware of the “stem cell turf war” that is raging right now. If not, basically the FDA has declared that if a doctor takes stem cells from your body and processes them beyond “minimal manipulation” he or she has in effect created a new drug subject to FDA jurisdiction and the agency’s drug approval process (Dr. Steenblock’s whole bone marrow treatments do not involve processing beyond ”minimal manipulation”). Regenerative Sciences LLC (Regenexx, Chris Centeno, MD) has filed several successive filed lawsuits challenging this and then was itself sued by the FDA (This case is discussed in a Forbes article that came out on 2-12-12, link below). The state of Texas (Texas Medical Board) has ignored the FDA and taken steps to regulate use of a patient’s own stem cells in ways that will let Texas doctors forge ahead and use them (Link to a 2-12-12 article follows below).  Patients and patient advocates have gotten involved by raising hell in blogs and websites including the creation of on-line petitions (A link to one such petition appears at the bottom of this blog entry).    

  According to the FDA, Your Stem Cells Are Now Drugs” (February 1, 2012)

  More on “Your body as a drug” (Blog made on February 6, 2012 on the Regenexx website by Chris Centeno, MD who’s firm is involved in litigation with the FDA challenging them to publicly declare their rationale for declaring a person’s own stem cells to be a drug and subject to their regulation)

  Stem Cells and the Lawsuit That May Shape Our Medical Future” (Forbes) –  February 12, 2012 -Article about the legal battle between the FDA and Regenerative Sciences LLC (Regenexx, Chris Centeno, MD) over “your stem cells are a drug”

   IV stem cell therapy safe for stroke patients” (Cardiology Today) – International Stroke Conference 2012 – February 9, 2012. Discusses 2 studies that undergird the “whole bone marrow” (bone marrow aspirate) intravenous approach that Dr. David Steenblock has been doing for over five years now. 

“Medical board moves to regulate adult stem cell use” (February 12, 2012) Texas Medical Board ignores FDA and sets up rules to govern adult (nonembryonic) stem cell use by Texas doctors

 GET INVOLVED! SIGN THIS PETITION: People for Ending Suffering Debilitating Illness’s: Keep the FDA Out of All Stem Cell Treatment”

 You can learn more about Dr. Steenblock’s FDA compliant whole bone marrow treatments for stroke, joint problems and more by visiting these web and blog sites:  http://strokedoctor.com/bone-marrow-stem-cell-therapy/, www.stemcellmd.com,  www.davidsteenblock.com and http://cerebralpalsycure.com/stem-cells/

And in this free 31 minute videoDr. Steenblock’s Office- STEM CELL Clinic

You can also call Dr. Steenblock’s Clinic toll free at 1-800-300-1063 and set up a phone consultation on-line at http://strokedoctor.com/contact/ 

  

Your chance to help change FDA rules on the use of your own stem cells by a doctor

stem cell treatmentsYour chance to help change FDA rules on the use of your own stem cells by a doctor

Have you ever found yourself angry with FDA policies or rulings? Wished you could change something that’s just plain wrong? This may be your supreme chance. The FDA has opened its doors to public input on existing regulations http://es.bna.com/federal1/20110427/hhs76p23520prule20110427.html:

In accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” the Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation. The goal of this review of existing regulations, as with our other reviews, is to help ensure that FDA’s regulatory program is more effective and less burdensome in achieving its regulatory objectives. FDA is requesting comment and supporting data on which, if any, of its existing rules are outmoded, ineffective, insufficient, or excessively burdensome and thus may be good candidates to be modified, streamlined, expanded, or repealed. As part of this review, FDA also invites comment to help us review our framework for periodically analyzing existing rules.

So which regulation deserves your attention? How about FDA 21CFR1271 (2004)? This regulation forbids doctors taking stem cell rich tissues from patients and doing anything to them beyond “minimum manipulation”? (Basically this means doctors can take stem cell tissue and give it back to patients but little else.  If, for instance, a doctor isolates and cultures stem cells from a patient’s bone marrow or fat tissue, that doctor — under current FDA regulations — has in effect created a new drug. And as a “new drug” these cells must receive FDA approval to be used.)

Interested in knowing more and maybe giving Uncle Sam your 2 cents worth? Well, patient advocate Barbara Hanson, who moderates a well known stem cell discussion board (Stem Cell Pioneers), has outlined precisely what people need to know and do to get FDA 21CFR1271 changed to allow doctors to take stem cell rich tissues and go beyond “minimum manipulation.” Here is a link to Mrs. Hanson’s “How to do it, to it” post:  http://www.stemcellpioneers.com/showthread.php?p=13618#post13618

Read the post and then, well,…do it, to it!

Share

Dominican Republic government to close stem cell clinics

stem cell treatmentsDominican Republic government to close stem cell clinics

Those of you have kept up with this and other blogs that touch on stem cell matters know that the X-Cell center in Germany ceased taking patients recently. Readers interested in learning more can do so by clicking this link (UK newspaper article.)

Now comes word that the government of the Dominican Republic “has moved to close several less-than-reputable stem cell clinics and ban untested stem cell procedures. Health Minister Bautista Rojas warned two weeks ago that he will direct regional health officials to directly notify the centres that the procedures are banned. Rojas told Dominican Today that he will seek to stop the stem cell treatments until they are authorised by the Bioethics Health Council, whose members said two weeks ago that they were concerned about the treatments. They noted that the methods were not scientifically proven and that their effectiveness in humans is unknown.”

You can read the entire article by clicking this link.

Obviously folks thinking of having a stem cell treatment in either Germany or the Dominican Republic must look elsewhere. If you happen to be in this boat you will logically want to zero in on a program that is legally bound to observe the highest medical standards and is subject to regulatory oversight. Many overseas stem cell programs claim this applies to them when it fact it doesn’t. This article will help fill in some of the proverbial blanks in this regard:   Foreign Stem Cell Treatments: How to Avoid Being Scammed 

But why go abroad at all when alternatives exist right here in the US? Specifically, Dr. Steenblock’s Clinic in Mission Viejo, California where over 1,000 legally sanctioned stem cell rich bone marrow transplants have been done during the past seven years; a clinic where physician and stem cell expert David Steenblock and his stem cell savvy medical team insist on making sure that things that interfere with stem cells have been identified and dealt with prior to each stem cell treatment; a clinic that takes into account the fact that the stem cells in the bone marrow of older people tend to be devitalized which they deal with by doing a unique series of treatments that helps purge the marrow of these (This promotes their replacement with healthy, robust new stem cells.) Then and only then are stem cell rich tissues harvested and given back to patients using very safe, approved medical methods.

In addition, Dr. Steenblock’s employs a through head-to-toe (Whole body or wholistic) approach with each patient that is based on his 40+ years of experience doing results-driven CAM (complementary alternative) medicine. Nothing is left to chance.

If you’d like to talk to Dr. Steenblock about your particular health challenges or needs you can do so by calling 1-800-300-1063. Dr. Steenblock is offering consultations today.

Don’t put your call off. If you are pressed for time or just prefer written over oral communication click this link and shoot Dr. Steenblock a message.

Share

Red Light (Stem cell treatment abroad), Green Light (Stem cell treatment here in the USA)

stem cell treatmentsRed Light (Stem cell treatment abroad), Green Light (Stem cell treatment here in the USA)

Europe’s largest stem cell clinic shut down after death of baby (GERMANY)

Doctor who treated MS victims with cow stem cells is banned (HOLLAND)

Medical Tourism Ethics: China Offers Unproven Medical Treatments (Complications including 5 cases of meningitis – CHINA)

‘Stem Cell’ Therapy, Delivered in a Bag, Left Him in Agony, SoCal Man Says (MEXICO)

21st Century Snake Oil – “60 Minutes” Cameras Expose Medical Con Men Who Prey on Dying Victims (MEXICO)

http://stemcell.md/newsletters/sept2010.pdf

Dr. Steenblock is offering medical consumers help sorting the wheat from the chaff when it comes to stem cell treatments. To schedule your consultation just call his clinic toll free at 1-800-300-1063!

Share

Why go abroad for stem cell help that’s available here in the USA?

Many of the things people need in terms of a stem cell-focused treatment or clinic are not being offered by most foreign private stem cell operations. Among these:

  • Pre-treatment preparation: Dr. Steenblock, who grew up on a farm in Iowa, likens getting a patient’s body ready to both receive stem cells and encourage their subsequent post-engraftment activity to preparing a field for planting and crop production. If one plants seeds in a field littered with rocks and bearing toxic amounts of certain noxious chemicals and heavy metals, the resulting crops will likely be less robust and have a far lower yield than if the field had had these detrimental influences removed or at least reduced.   In addition, a patient’s own stem cells should be mobilized into their circulation prior to or during a stem cell-based treatment.
  • The treating clinic or hospital should be experienced in the use of those growth factors, hormones and drugs that tend to make stem cell engraftment and post-treatment activity more certain and powerful.
  • The treating doctor or doctors should be very experienced in doing stem cell therapy, especially if this entails harvesting bone marrow or fat tissue.
  • The treating facility should have a track record of doing safe work.  Reports have surfaced of some patients treated in China having contracted meningitis after an infusion of stem cells into their spinal canals (A procedure known as a “lumbar puncture.”)

Foreign Stem Cell Treatments: How to Avoid Being Scammed – by Dr. A.G.Payne

 A Checklist for Those Contemplating Doing Stem Cell Therapy Abroad Nov 2010

  • The treating clinic or hospital should be documenting their treatments and doing follow-up in terms of patient needs and responses.
  • The treating facility should be using leading edge technology to mobilize a patient’s own stem cells prior to or during his or her stem cell-based treatment and also for encouraging maximum post-treatment responses.
  • The treating clinic should provide pre- and post- dietary and lifestyle guidelines. This harkens back to the “preparing the field for seeding and crop cultivation” above.

How does Dr. Steenblock’s legally sanctioned bone marrow transplant program stack up viz-a-viz these standards? Let’s take a look:

  • Dr. Steenblock has everyone who undergoes his stem cell rich bone marrow-based treatment be tested for and (when indicated) treated to bring down unacceptably high levels of heavy metals toxicity; identify & eliminate overgrowth of certain fungal and bacteria microorganisms in the gut; balance various hormones, and much more.
  • Dr. Steenblock employs a proprietary blend of FDA approved drugs and such that both mobilize a patient’s own stem cells and prepare his or her tissues for stem cell engraftment, multiplication and activity.
  • Dr. Steenblock began working with bone marrow transplants back in 1969 while studying in the University of Washington’s Department of Hematology. He has successfully performed over 1,000 bone marrow transplants since 2006. No post-treatment infections or major complications have ever cropped up in any patient treated.
  • Dr. Steenblock has a team of professionals including a biostatistician tracking patients following their bone marrow-based transplant.
  •  Dr. Steenblock employs some very sophisticated devices such intermittent hypoxia http://en.wikipedia.org/wiki/Intermittent_hypoxic_training , Functional electrical stimulation http://en.wikipedia.org/wiki/Functional_electrical_stimulation   and Whole Body Periodic Acceleration Therapy http://www.nims-us.com/studysupport.aspx  to both help mobilize a patient’s own stem cells prior to or during his or her stem cell-based treatment and to encourage maximum post-treatment responses.
  • Dr. Steenblock and his very capable staff provide each patient with pre- and post- treatment dietary & lifestyle guidelines.

There are a few other things worth mentioning that are big pluses when it comes to Dr. Steenblock and his bone marrow transplant program:

  • Dr. Steenblock’s transplant program is carried out right here in the United States, in his clinic in southern California as a matter-of-fact. For most folks his facility is only hours away by plane. And best of all, passport and Visa issues do not enter into the picture for those in the USA.
  • Value: Dr. Steenblock’s program has treatment options that readily fit most budgets.

All things considered, why fly off to a less advanced, pricey foreign stem cell clinic when you have Dr. Steenblock’s superb program right here at home?

You can find out if stem cells can help your condition for FREE. Just call Dr. Steenblock’s clinic at 1-800-300-1063 to arrange for your free 5 minute phone consultation.

Share

Cell-Based Medicine Now: Dr. David Steenblock Joining Other Pioneers of New Medical Specialty at Historic Conference (November 11-12, 2010)

ICMSOn November 11th physician and medical innovator Dr. David A. Steenblock will join a gathering of fellow pioneers in the field of cell-based medicine at the historic 2nd annual International Cell Medicine Society (ICMS) conference in Las Vegas (Nevada.)

The ICMS is a nonprofit organization with over 1000 members across the world, all of whom are passionately devoted to the research and application of regenerative and cell-based medicine.  Some of the US physicians who are attending such as Dr. Steenblock actually harvest and use a patient’s own stem cell rich bone marrow to treat them, while a handful of others such as Christopher Centeno, MD are actually isolating and culturing stem cells from a patient’s own bone marrow and fat, and then treating them right in their own offices.  Dr. Centeno, who is ICMS’s medical director, is a widely acknowledged expert in the processing and culturing of nonembryonic (adult) stem cells to treat orthopedic injuries.

Dr. Steenblock, whose stem cell medicine work and advocacy is represented on www.stemcell.md, has done over 1000 whole bone marrow transplants since the early part of this decade.  According to him, “There is a worldwide rush to research stem cells and to bring them to the clinic. Contrary to most all of the media’s claims that stem cell therapies are far in the future, stem cells can and are being given to my patients on a daily basis. These are cells that have the potential to rejuvenate organs and tissues by growing and changing into specific cells that are needed for tissue repair.”

Not surprising, the number of medical turnarounds in people who have received Dr. Steenblock’s whole bone marrow transplants is both large and impressive and growing day-by-day.

If you’d like to learn more about Dr. Steenblock’s stem cell medicine program you can do so by clicking this link http://stemcell.md/newsletters/sept2010.pdf or by calling his clinic toll free 1-800-300-1063.

For those interesting in meeting up with Dr. Steenblock at the ICMS convention on November 11-12, here is a link to the meeting web site: http://www.cellmedicinesociety.org/conference/info/agenda

Share

Stem Cell Awareness Day – October 6th!

Stem Cell Awareness Day – October 6th!

Today is “Stem Cell Awareness Day.” No, you won’t likely find a Hallmark card to commemorate this special day, but  it takes very little time on the Web to….well….raise one’s awareness. Here is one example gleamed from a quick web search –  something US House of Representatives Speaker Nancy Pelosi said in connection with stem cell research:  “Every family knows they are one phone call or one diagnosis away from needing what stem cell research can yield for us.”

 

stem cellstem cell
Images from the National Institutes of Health Image Bank  NIH Copyright Notice

Thankfully, nonembryonic (adult) stem cells are being employed in hospitals every day to combat certain blood borne diseases, and in clinical studies to gauge their safety and therapeutic impact on a wide range of diseases and medical conditions such as ALS, cerebral palsy, multiple sclerosis and spinal cord injury.

In addition, a handful of pioneering doctors are treating patients using autologous (= their own) stem cell rich bone marrow. One of these is none other than this blog’s namesake, Dr. David Steenblock.  Got six minutes you can spare to take you own “stem cell awareness” up a notch? Then check out this video: http://www.youtube.com/watch?v=lo28-KduxmA

www.stemcell.md1-800-300-1063

 

Share

Action Alert: Help keep the FDA from classifying your own stem cells as a drug

To all who favor a doctor’s right to use of a person’s own stem cells to treat their health needs right here in the USA:

The FDA is maneuvering to stop MDs and DOs from being about to harvest and use a person’s own stem cells to foster respire and restoration in their bodies.  Many experts in medicine and stem cell use consider this move by the FDA one geared to do something they hitherto had been unable to do – namely control what medical procedures physicians do in their practices. This move has apparently followed on the heels of a legal battle twixt the FDA and a clinic in Colorado whose medical director, Christopher Centano, MD and his associates have been using stem cells from patient bone marrow samples to treat joint issues primarily. The fact Dr. Centano takes the cells, multiples and grows them, and then re-injects them back into the patient is what the FDA takes umbrage with. Why? The FDA regards any manipulation of extracted bone marrow or other tissues beyond what it terms “minimal” equivalent to the creation of a new drug; and new drugs are the province of the FDA in terms of requiring formal testing (clinical trials) and then approval by them for use by doctors. Dr. Centano and many others who support him vehemently disagree with the FDA spin on the use of autologous (à from self) stem cells and to this he (Dr. Centano) has filed a lawsuit against the FDA.   Supporters of Dr. Centano including Dr. Steenblock are urging medical consumers to show their support for keeping the use of autologous stem cells a matter between doctors and their patients. One way the public can get involved is to go to this website http://www.thepetitionsite.com/1/PetitionforAdultStemCells/ and complete and submit the on-line petition form. Thanks!

Share
WordPress SEO