Tag Archives: adult stem cells

The History of FDA Control of Your Body

May 18th, 2013

(Click image to watch video)
sm1For the first time in history the FDA has encroached into the practice of medicine. The FDA made autologous adult stem cell therapy subject to the same regulatory oversight as mass-produced pharmaceutical agents. Without compliance to the Administrative Procedures Act requiring an “extensive public comment period.“ The FDA managed to expand it’s authority, without input from patients and their doctors…

sm2In the early 1990’s, the cells in your body were like any other body part that could be used by a physician and moved from one area to the next. They were body parts like a kidney or a heart. That was before an unprecedented power grab by the FDA.

sm3In the late 1990s, the FDA proposed that the cells in your body should be made drugs. They were met with stiff resistance. They ultimately decided, that if the cells were at all made more potent by growing them to bigger numbers, they would be drugs, even though they were still your cells. This was known as the “minimal manipulation” rule later codified in 21 CFR 1271.1-3. In the 1990’s this only applied to someone else’s cells that were manufactured like drugs, so this made some sense.

sm4The FDA, without the proper notice and comment making period required by the Administrative Procedures Act, made a one word midnight change in the 2006 federal register. It changed a single word from “another” to “a”. By doing this, it’s regulatory authority was expanded from simple control over someone’s cells used as a transplant from “another” person to all cells from “a” person. With this one work change, FDA granted itself sweeping new authority over your body.

sm5Up until 2008, it was assumed that FDA only meant to apply it’s rules to pharma companies who were processing cells. Then in 2008, FDA went after a physician’s office that was using the patients own cells and treated the small doctor’s office like a large Pharma company. This necessitated a suit by the doctor’s office against FDA, but this chain of events now extended FDA’s authority even further, as now your local family doctor was suddenly under the same cell based regulations as Pfizer.

sm6In 2010 and 2011, the FDA decided to place fat tissue processed at the patient’s bedside to release stem cells into the same category as prescription drugs. They made this intention clear through letters to several parties that asked the Tissue Reference Group whether this simple processing of fat was something FDA intended to control. In addition, it submitted Warning Letters to Intellicell and a Dr. Young, codifying it’s intent to turn fat tissue into a drug.

sm7So as you can see, FDA has gone from no control over your body’s stem cells as drugs in the 1990’s, to classifying an ever increasing number of you body tissues as drugs. This is despite massive opposition from these industry groups.

♦ American Red Cross
♦ Society for Assisted Reproductive Technology
♦ Osiris Therapeuticsc Inc.
♦ Northwestern University
♦ Hyman, Phelps & McNamara
♦ Biotechnology Industry Organization
♦ American Society of Clinical Oncology

What is the impact of classifying simple medical procedures as prescription drugs? The FDA has taken procedures that should by now be routinely performed as the practice of medicine, and instead placed them into a glacially slow drug approval process. Countless sick patients have been denied access to their own stem cells that may well cure or mitigate their disease.

sm8Share this page with your friends. Ask your local university if they have a focus on adult stem cell research, specifically autologous mesenchymal stem cells, expanded to a therapeutic dose. Educate your state and congressional representatives. Citizens need to take charge of the way their body parts are being regulated.


Further Reading:

FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!” Alliance For Natural Health, January 31, 2012

Why Can’t We Use Our Own Stem Cells to Heal Our Bodies? by Berkley Bedell, former Congressman and founder of The Foundation for Alternative and Integrative Medicine (FAIM)

FDA Stem Cell Regulation and the English Language: switched at birth? Mary Ann Chirba, J.D., D.Sc., M.P.H. August 11, 2011

FDA Oversight of Autologous Stem Cell Therapies: Legitimate Regulation of Drugs and Devices or Groundless Interference with the Practice of Medicine? Mary Ann Chirba, J.D., D.Sc., M.P.H.

Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor’s new clothes The Journal of Translational Medicine 2012 10:60


How You Can Help Raise Awareness About Adult Stem Cell Therapy

ClaireClaire Hooper is a member of Patients For Stem Cells. She needs stem cell therapy herself, and recognizes that helping everyone rescue their right to this life saving therapy is the best way she can help herself.
Here she shares tips on how to do an online petition, and how she succeeded in landing an interview, which will educate readers and amplify the reach of her stem cell petition. Everyone can follow Claire’s example and make change happen!

Here is my stem cell petition, followed by the link for signing it.

Using Our Own Stem Cells to Cure Disease
President Obama: please stop the FDA’s assertion that the use of our body’s own adult autologous stem cells (AASC) are a “biological drug” and thereby subject to FDA regulation. Allow us to use our own stem cells to heal our bodies of chronic illnesses and injuries. AASC therapies offer a less expensive, comparatively safe, and more effective outcome for many diseases than do conventional medical treatments. Other countries are perfecting cures for cancer, diabetes, heart diseases, kidney diseases and many other chronic conditions. FDA control of a person’s own stem cells stifles medical progress and threatens the lives of those dying from curable illnesses.
Petition Background: I, like millions of other Americans, suffer from chronic back and knee conditions that could be cured with the use of my own stem cells in a safer, cheaper, and more effective means than by the options offered by conventional medical treatments.

Click HERE to sign, and use the share buttons below this post to get this story and my petition out to as many contacts as you can. Social media is a powerful tool that can be used to educate everyone about this complex topic.

For anyone who is thinking about posting a petition online, here is what I have learned from my own recent experience.

♦ The title tells the story.
I titled my petition: Using One’s Own Stem Cells to Cure Disease.

♦ Be brief; use simple, straightforward language.
The message had to be short and simple. It was a challenge to convey in so few words what the use of autologous (one’s own) stem cells is and what the FDA is doing to suppress it.

♦ Think about timing.
I started my petition in mid-December of 2012. In hindsight, I realized December was a poor choice of timing because people are busy with holiday expenses, travel, family, etc. Nonetheless, I embarked upon this experiment.

♦ Use as many platforms as you can.
Signon.org provides a convenient place to begin. After launching the petition on signon.org, I posted it on Facebook incessantly, often paying to “promote” the post to boost its profile. I posted my petition on StemCellPioneers.com and PatientsForStemCells.org where I began connecting with other stem cell advocates.

♦ Follow up, use personal contacts.
I sent e-mails and private messages to friends and family asking them to please sign and share my petition. I made phone calls to friends who hadn’t signed it because they did not understand the issues. The immediate responses were impressive; then the pace of the number of signers slowed to a halt. It looked as if the petition had lost its momentum after such an auspicious start.


Patients have made recent progress in getting national coverage about the loss of our rights to life saving stem cell therapy in Business Week, Forbes and NPR. This makes it easier to get local coverage.

♦ Approach journalists you respect.
Contacting the right journalists can help. I got lucky. A friend of mine, Andrew Strange, who works for University Press at Lamar University, saw and signed my petition. He then told me another journalist there, Chelsea Henderson, was doing a story on stem cell treatments. He asked if I would mind his giving Chelsea my contact info; I agreed for him to do so.

♦ Connect with your allies, both individuals and organizations.
Another friend who saw and signed my petition, Ange Busceme, connected me with stem cell advocates and stem cell patients. I joined Patients for Stem Cells. These groups helped to revive my flagging petition. Through them, I met more stem cell patients and advocates. They are an amazing source of stem cell research, inspiration and support!

♦ Prepare for interviews. DO seek help from people who know more than you!
When Chelsea, the journalist, called me about doing an interview about my petition, I got cold feet. Thanks to all of you who encouraged me and offered support! Preparation steadied my nerves. I made notes to use as prompts for my talking points. I thoroughly reviewed all the available information and made an outline of the issues I needed to discuss. I used materials provided by the stem cell advocacy groups to illustrate the issues in a straightforward graphic format.

The interview seems to have gone swimmingly! Now the journalist has received permission from her editor to do an entire series devoted exclusively to autologous stem cells this coming fall!

♦ Keep following up.
Good luck with your petition and interviews! If you have suggestions or want to share your own experience, use the comment box below.

About the author: Claire is no stranger to making positive changes for various causes. She founded Hooper’s Heroes, which provides scholarships for socioeconomically disadvantaged high school and college students who demonstrate academic excellence and a commitment to community service. She also works with Stable-Spirit, a nonprofit organization providing hippotherapy and equine-assisted therapy to people dealing with the effects of crisis, trauma, physical challenges and other issues.

Want to become a member of Patients For Stem Cells? Just subscribe to our blog.


How Safe Are Stem Cells?

Stem Cell RiskHow safe are adult stem cells? This has become a hotly debated argument. There are financially conflicted scientists who frequently cry wolf over the safety of adult stem cells. Taken from your own body, then expanded to a therapeutic dose, mesenchymal stem cells are showing promise for treating many previously incurable illnesses. Why the objections? Theses scientists hold patents in, or receive grant money for, embryonic or IPSC stem cell research, which could be threatened by this safer therapy, already in use and saving lives today.

Paul Knoepfler, PdD, a scientist at UC Irvine pursuing induced pluripotent stem cell (IPSC) research, is one of these critics. In his blog he challenges patients who have had adult stem cell treatment: Critically reading science papers: response to patient on MS stem cell literature.

As evidence of danger, he presents 3 reports covering 9 patients that had adverse outcomes.

Patients For Stem Cells conducted some fact checking. We found 66 studies in pubmed.gov, showing there have already been over 2,154 patients treated with their own EXPANDED mesenchymal stem cells. These reports consistently conclude treatments were well tolerated, with little to no side effects other than transient fever, and that further research is warranted. This is evidenced by the 1,630 patients in 54 EXPANDED mesenchymal stem cell trials currently underway, listed at clinicaltrials.gov.

See our report on these findings How Safe Are Stem Cells?.

Arnold Caplan, PhD, from Case Western Re serve University and a leader in stem cell science has recently stated that more than 250 mesenchymal stem cells trials are ongoing or completed. The 120 trials we found are a subset of this larger number, because we limited our search to expanded or cultured cells, since this is what the critics have been crying wolf over, and calling for the FDA to withhold this life saving therapy from patients.

We challenge the critics to disprove the growing evidence base that shows adult stem cell therapy is safe.

Samantha Wilkinson,
Member, Patients for Stem Cells