Your Own Cells Are a Drug You May Lose the Right to Use

by Chris Centeno, MD /

stem cell rightsThis next few decades in medical breakthroughs will be an interesting competition between expensive drugs and inexpensive cells taken from the patient’s body. In some ways, this battle will define how we as a society deal with healthcare costs, regulation, and affordability in the 21st century. Regrettably, the powers that be here in the early part of the century are doing a great job of keeping cheaper and safer cells from patients, in favor of more expensive and often more side-effect laden drugs. What’s finally decided in key FDA hearings this year will impact every American’s healthcare bill for the foreseeable future.

The Regulatory Morass That Got Us Here…

Many years ago in the late 1990s, a morality play unfolded that would impact 21st century healthcare and nobody noticed. Basically, the FDA held public hearings to define how cells would be regulated. At the time, the idea was that one day in the not too distant future, stem cells would replace drugs as effective treatment for many chronic diseases. The FDA felt these cells needed to be regulated like drugs, while pretty much everyone else thought that this wasn’t needed. If you want to get the tenor of the meetings, you only need to look as far as the letter to the FDA sent by the ASCO in 1998, representing the world’s largest professional organization of cancer doctors:

“ASCO objects in the strongest terms to FDA’s proposed regulation of stem cell transplants. This misguided proposal is unnecessary, would jeopardize the proper treatment of cancer patients and impede the development of new therapies, would substantially increase the cost of stem cell transplants, and exceeds FDA’s legal authority. The proposed approach should not be adopted.”

Despite this vigorous opposition, the FDA decided to regulate cells just like drugs. By 2006, it extended that reach to also include, under certain circumstances, the cells in your body! Prior to that, their cells=drugs regulations had only applied to cells that were mass manufactured like drugs.

Why All of this Came to Be…

Do we need expensive and side effect laden drugs or do we want to use the cells in our own body to heal ourselves? The FDA has spoken about what it wants, but the American people largely don’t understand what’s happening. A recent study on a new drug to treat the horrible disease of osteonecrosis will help you understand the problem that the FDA caused in the late 90s and that it is still pursuing today.

The new drug above is an artificial form of a naturally occurring growth factor–a chemical that causes cells to grow. The issue is that thus far, these artificial growth factors have had an awful track record. One that’s on the market right now called BMP is being used by spine surgeons to promote low back fusion. It has horrendous side effects because the drug company, to improve bone growth rates and help guarantee an FDA approval based on efficacy, increased the dose thousands of times over what your body uses naturally to heal bones. This has caused many patients to have bone growing where it shouldn’t be, along with increased cancer rates. Finally, even after the manipulation of the dose, the BMP product isn’t even as effective as using your own bone marrow stem cells to help fuse bones.

In this new study, the new growth factor drug in a Japanese phase 1 clinical trial helped osteonecrosis patients avoid hip replacement surgery. At first glance, that would seem to be a modern miracle, as osteonecrosis is a disease where the bone dies. However, the patient’s own bone marrow stem cells have shown since the late 90s that they can do the same thing. In addition, they can do this much more cost effectively and with far fewer possible side effects. So why are we seeing this new clinical trial starting for a drug that’s not needed?

The new drug will be able to be mass produced and distributed like any blockbuster pharma concoction. However, given the price of existing growth factor drugs, it will cost 10-100 times more than using your own stem cells. Given that choice, most insurance companies would vote with their wallets and pay for your stem cells versus the new hyper-expensive and likely more side-effect laden new drug. This is why if you’re a pharma company executive, the FDA’s march to turn your cells into drugs is fantastic. It gets rid of the cheaper competition, forcing consumers to purchase the expensive drug. Who cares if that drug has a few more side effects? After all, it will just be part of a class action suit at some point down the road, that will pay out only a fraction of the billions in sales.

Even the New Rules Weren’t Enough…

When the FDA began pushing for the cells in your body to be drugs, the ultimate expression of government control over our bodies, the focus was on cells that were more heavily processed. For example, ones that were cultured in a lab to grow more cells. While we’ve seen some definite advantages to using this type of therapy for certain types of medical conditions, it turns out that a good number of orthopedic and other conditions respond well to cells that are less processed. So while the initial FDA guidelines were made to get rid of the competition, they wouldn’t preclude this type–what the agency has termed “minimally manipulated”. So what to do? Change the rules of the road once again!

This April the FDA will hold hearings to finalize these new rules, which has a curious loophole to allow the agency to name just about any cell in in your body, under any condition, a drug. This is called the homologous use rule, which means that the cell must perform in the body the same function that it performs in the therapy. While at first blush this sounds reasonable, how it’s being interpreted is draconian. For example, the FDA has stated in it’s draft guidance that if a doctor treats a breast cancer patient who needs reconstruction, and takes cells from fat from another part of the body to replace the lost breast tissue, this is an illegal drug manufacture event! Why? The FDA claims that the only function of the breast that it will recognize under homologous use is lactation!

The good news is that the word on the street is that the FDA has been overwhelmed by the sheer volume of angry speakers who have registered for its April hearing on the new rules. The bad news is that unless tens of thousands of angry patients and media outlets get involved now, just like the in late 1990s, the FDA will just finalize its two decade march to block the cheaper and more common sense competition of using your body’s own natural resources to heal what ails you.

What are the Implications?

What happens if the FDA is successful? The example above gives a motive and reasoning why the efforts have become more and more non-intuitive. There are countless drug plays under FDA review that will potentially earn billions of dollars, but likely won’t perform any better in clinical trials than using your own cells. At a time when the nation is struggling to pay for healthcare, getting rid of cheaper and safer alternatives is ill advised.

Even if these new rules go through, the FDA still has another glaring problem to handle, which is PRP. Platelet Rich Plasma has turned out to be an effective treatment for everything from mild arthritis to severe tendinopathy. These conditions are also targets for new drugs that could net pharma more billions. Hence, there is only one logical conclusion. PRP is also on the radar, once your own stem cells are taken out of the equation.

The upshot? Take action now to preserve your right to use your own tissue as part of a medical procedure! This is it, the final chapter in a regulatory land grab that began more than twenty years ago. Below are some ways you can take action as a patient or a concerned physician.
Here’s a link to a great story by ANH on this topic. 

The Alliance for Natural Health has built a “Take Action Page”, click the button below to make your voice heard!

[button link=”http://www.anh-usa.org/action-alert-fda-regulates-your-cells/” color=”custom” size=”large” type=”flat” shape=”square” target=”_blank” title=”Make Your Voice Heard” gradient_colors=”#ffeab0″ gradient_hover_colors=”#ffeab0″ accent_color=”#dd3333″ accent_hover_color=”#dd5454″ bevel_color=”#ffffff” border_width=”3px” shadow=”” icon=”” icon_divider=”yes” icon_position=”left” modal=”” animation_type=”0″ animation_direction=”down” animation_speed=”0.1″ alignment=”center” class=”” id=””]CLICK HERE TO MAKE YOUR VOICE HEARD![/button]

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25 thoughts on “Your Own Cells Are a Drug You May Lose the Right to Use

  1. Dennis

    Wow. Correct me if I’m wrong, but I know the heavy-handed federal bureacrats effectively outlawed stem cell procedures that are more than “minimally processed” (i.e. hello Cayman Islands, for those who can afford it), but, bottom line, does this mean if the FDA is “successful,” the same day stem cell procedures offered by Regenexx will no longer be legal? If so, what would be the timetable of this and does Regenexx plan to litigate/fight it (that I know would be expensive) if this occurs?

    1. Regenexx Team Post author

      Dennis,
      The FDA hasn’t changed it’s goals since the 90’s. This is however THE time for people to get involved and make their voice heard, as that’s the best chance we have as citizens and medical consumers with rights over our own bodies, to maintain those rights. The issue is much bigger than what we do, it’s the biggest trimtab moment in medical history since Penicillin.

  2. Tommy

    I have seen PRP work on so many people and in so many different ways. Of course each individual needed its on care plan, but the common factor was PRP. I have seen it work in general, orthopedics,gynecology, and wound care clinics. Patients with no insurance have a chance to heal the body using there own platelets and/or stem cells. I have visually seen a wound heal on a former NFL player that was there for 18 years. 18 years that is not a miss print. It took him 3 treatments over 2 months from first PRP application. We need to act now, and conserve your rights over your body.

    1. Regenexx Team Post author

      Tommy,
      Thank you for sharing that. It is one of those things that is so primary, it is taken for granted. Each of you who have taken the time to comment, please follow the link on the blog and post your comments.

  3. Frank D.Manart, M.D.

    I am a retired surgeon contemplating primary stem cell therapy for an ACL injury. I read your opinion paper with interest. I believe that the FDA is highly subject to a powerful and wealthy pharmaceutical lobby. And in addition, the FDA is also an inept and inadequate agency. That is a difficult combination of factors for any agency that is responsible for regulating a huge (and very profitable) industry. Unfortunately, also involved is the concept of “a fox in the henhouse.” A recent example of their inadequacy in managing a serious problem was the FDA’s response to the introduction of the Ebola virus in Dallas last summer. Their director appeared to be an idiot who could not think or talk clearly. He was unfit for public display. Nothing has changed since then, so I don’t envy your situation now. I wish you well in your efforts to favorably influence the further development of stem cell research and its clinical application.

    1. Regenexx Team Post author

      Dr. Manart,
      Thank you. Hopefully your comment with it’s wide angle lens perspective will help people to see…

  4. Barbara

    It’s mind boggling to me that there isn’t full support for patients from the research community, doctors, media, etc. Instead, patients are having to beg for their lives and hope that the FDA does not take away our choice to be treated with our own stem cells. Shame on those who support such onerous guidelines. My dog has more rights than I do. She just had stem cell treatment, her cells were expanded and banked for future use. This is all about money and we all know it. What a sad state of affairs when my own body parts may soon be off limits to me.

    1. Regenexx Team Post author

      Barbara,
      Eloquently stated!

  5. Denis

    I urge everyone to click on the link above (“Click Here to Make Your Voice Heard”) and follow the instructions. It only takes a few minutes. After a quick check, I see that President Obama’s new nominee for FDA Commissioner, Dr. Robert Califf, has been criticized for having financial ties to pharma (per Time Magazine, 9-16-15). I don’t know if this means anything, but another quick check on the Open Secrets Website, from the Center for Responsive Politics, reveals that Dr. Califf has made four $500 contributions to the American College of Cardiology.

    1. Regenexx Team Post author

      Denis,
      Thank you for spreading the word; it is truly important!

  6. Ken Katz MD

    Utterly abhorrent, myopic behavior. Yet what else from those that approve new long acting opioids yet potentially step on a true cure. And when a member of the fda or his/her family member needs help…. Go have surgery and get mrsa. Time for the fda and medicine to stop embarrassing itself and embrace the truth. I’m in.

    1. Regenexx Team Post author

      Ken,
      Not to mention Fentanyl Lollipops! Glad you’re in!

  7. Patti Sullivan

    Thank you for posting this link! My husband received stem cells for his shoulder last April and has full function and strength. This treatment needs to remain an option.

    1. Regenexx Team Post author

      Patti,
      Given that the alternatives are medications that miss the mark, and surgeries which create additional problems, it is very important. Wonderful to hear your husband is doing so well!

  8. Jake Wardwell, D.O.

    I plan to go to speak at that hearing to show pictures of fat in joints and tendons. Every joint I look at under ultrasound has a joint capsule and a fat pad right under it. When tendons atrophy they develop fatty infiltration. When I inject fat into a tendon or joint it serves a role of structural support as a biological scaffolding for the innate healing capacity of the body to occur. Not only is fat native to where I’m injecting it, but it’s also serving a similar role to what it is doing in the subcutaneous tissue. Then I’m going to show a slide show of some of the small miracles I’ve performed with fat, bone marrow, and amniotic membrane like repair of a complete ACL tear, complete Supraspinatus tear, non healing wounds, meniscal tears, etc All with before and after MRI/ultrasound to show just how effective these modalities can be.

    1. Regenexx Team Post author

      Jake,
      It sounds like a great presentation. They need to know that this is not theoretical…it is helping people and changing lives for the better every single day.

  9. Phillip Zinni III DO FAOASM

    Thanks Chris, I just passed on to my network, keep up the good fight. Phillip

    1. Regenexx Team Post author

      Thanks Phillip!

  10. Penny Nelson

    Just sent my response. It’s been three years post-procedure and I cross country skied yesterday! Happy that I don’t have to go through a total knee amputation. Thanks for the heads up!

    1. Regenexx Team Post author

      Thank you Penny! So wonderful to here you are out there cross country skiing! If everyone would take those few minutes, we will be in good stead…

  11. Jim L.

    I’m pissed! This is not my last comment . This is my first! Somehow, some way, I’m going to become an advocate for medical freedom as apposd to the medical tyranny that is being inexorably bulldozed over our God given right to heal ourself in the most effective means possible. How dare those bastards of medical policy call themselves our representatives of good governance.

    They are not charlatans, they are not naive, they are dark evil money grubbing parasites on humanity. I am pissed. That is my opening comment.

    Jim L.
    Ps my new title in retirement…..advocate / activist for non-governmental consensus based, logical, rational, human-health solutions, free of politics and money grubbers .

    1. Regenexx Team Post author

      Jim L,
      Please use this link to let the FDA know how you feel at: http://www.anh-usa.org/action-alert-fda-regulates-your-cells/

  12. Joseph Torsiello

    I’m 84 years old. 5years ago I could hardly walk. I had stem cell injections in boat knees. After 5 years I still play tennis and walk without pain. Last week I had stem cells injected in my right shoulder which is very sore Will let you know the outcome

    1. Regenexx Team Post author

      Joseph Torsiello,
      Thanks for the wonderful update! As Dr. Centeno (who developed the Regenexx Procedures) has said, the best gift a doctor can receive is knowing that his best was good enough to help someone. Please do keep us in the loop re your shoulder.

  13. R.B.

    What will happen if the FDA wins? What will happen to Regenexx? What will happen to patients who previous received stem cells treatment? Will they be denied insurance in the future by this regulation?

Chris Centeno, MD

Regenexx Founder

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications.
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