Take Action! Preserve Access To Stem Cell Therapy In The U.S.

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Your Urgent Help Needed! New FDA Draft Guidance on Physician use of Platelets and Stem Cells Seeks to Drastically Limit What Physicians can do to Help Their Patients

UPDATE: Thank everyone for submitting 381 comments! We will keep you posted on the outcome.
The public has the opportunity until Dec 22, 2014 to present comments to the FDA regarding regulation of adult stem cells.

You can jump to the TAKE ACTION INSTRUCTIONS below, but here’s the situation.

Patients For Stem Cells opposes this draft exemption in its current form because it further limits access to use of autologous (your own) stem cells to treat illness and injury. Many of our members have found cellular medicine to be safe and effective. Further government restrictions are not needed.

“Those with congressional contacts should make them aware of what is happening. Many of our government agencies e.g. FDA, EPA are taking unprecedented actions. These are unelected government officials making “laws” for US citizens. I doubt this is what Jefferson, Adams, et al had envisioned for our country!”
~ Gerard Malanga Partner at New Jersey Orthopedic and Sports Medicine, LLC

The History: Over the past decade, many things that were previously defined as the practice of medicine in cell based regulations have been moved from physician to FDA control. These have included cell culture and the bedside processing of fat tissue. Now centrifugation could be the next physician right to fall under FDA regulation. This last problem is part of a new FDA draft guidance.

The Issue: Larger and larger numbers of physicians are using platelet rich plasma (PRP), bone marrow concentrates (BMC) or adipose derived Stromal Vascular Fraction (SVF) in their medical practices. These are usually prepared by an automated bedside centrifuge at the point of care (POC). The physician’s ability to process cells in this way has been allowed by FDA through an exemption in its cell based therapy regulations codified in 21 CFR 1271.15(b). This exemption has been narrowed most recently in 2006 to allow simple processing steps like centrifugation, but to exclude culturing or more extensive processing of cells. The draft guidance in question now seeks to narrow this exemption further to manual tissue preparation during the same surgical procedure (i.e. the cutting, shaping, or washing of whole tissue). Curiously exempt from the draft guidance is centrifugation, despite numerous 510K cleared devices in existence that use this technique to isolate platelets from blood or concentrate the stem cells in bone marrow. If the guidance is adopted, the big picture implication is that any physician using centrifugation to process cells at the bedside and part of the same surgical procedure, could be regulated not by his or her state medical board, but also by the FDA. This would mean dramatically increased costs for physicians who would need to register with FDA, to hire expensive consultants to produce tissue processing quality systems, and to employ consultants or other employees to keep the physician’s office up to the standards that the FDA sets for the wholesale processing of tissue. The practical implication of this guidance is therefore that few physicians will spend the time, money, and employee resources to be compliant, either causing them to avoid these simple and helpful therapies or leaving them open to enforcement actions by the FDA.

What can you do now? The FDA has asked for comments on the guidance. They normally receive a few scattered letters from physicians on these issues, but we have the opportunity to make our voices heard on a massive scale. Be sure to share this post!


Here’s how you can tell the FDA and your representatives what this means to patients, and their doctors.

1. Comment:, see examples below, which you can copy/paste.
Or you can just enter ” I oppose this draft exemption in its current form “.

Click HERE once you have your comment ready. Paste it in the Comment box (opens in a new tab so you can come back to these instructions).

2. Enter your name (required) and location (optional)

3. Under I am submitting on behalf of a third party
Submitter’s Representative: – leave blank
Organization Name: – enter PatientsForStemCells.org

4. Category: choose “Consumer Group”
Do NOT select “Individual Consumer”, or your comments will not show up publicly.

Before you click Continue button to submit,
copy your comment so you can also send to your Representative (step 5. below).

5. Find your Representative and email them the comment you copied, and a link to this post so they can get the background.
Here’s the link http://www.patientsforstemcells.org/preserve-access-to-stem-cell-therapy-2

It may take a few days for your comment to get reviewed and posted at the Federal Register. You can read the comments here. We will also send out an update on the outcome.

Thank you for your help!

Example comment from patients (please edit and personalize):

I oppose the draft exemption in its current form. As a patient, the access to my body’s own tissue is a serious concern. FDA’s new draft guidance would further limit what my physician can do to help heal or treat my condition. Forcing physicians out of inexpensive autologous cellular medicine (that uses my own cells to help heal or mitigate my disease) and into expensive tissues purchased from a tissue bank or a drug company will limit and not expand access to this type of medical care.

Example comments from physicians (please edit and personalize):

I oppose the draft exemption in its current form. As a physician who uses centrifugation to process autologous cells at the bedside, I am concerned that your recent draft guidance doesn’t explicitly state that physicians can use this technique to help isolate their patient’s cells at the bedside. This will impede my ability to cost effectively treat my patients by forcing me to either register with FDA as a tissue processor or to purchase much more expensive and potentially more side effect laden cellular drugs and or allogeneic tissues.
I oppose the draft exemption in its current form. Platelet rich plasma and bone marrow concentrates are a key feature of my practice that I have used to help patients recover from orthopedic injuries. Further limiting access to these autologous therapies by not explicitly stating that centrifugation is allowed under 21 CFR 1271.15(b), will force me out of using this type of care for my patients. As a small medical practice, I cannot afford to spend the hundreds of thousands of dollars that registration and compliance with FDA 361 tissue processing guidelines will require.
I oppose the draft exemption in its current form. Autologous biologics are key to promoting the inexpensive physician led innovation that will help contain the future costs of musculoskeletal care. By not explicitly listing centrifugation and other parts of the minimal manipulation guidelines outlined in 1271, the FDA is reducing physician access to these inexpensive technologies.
I oppose the draft exemption in its current form. Centrifugation is a technology that has been used for a century by physicians, but is not included under the draft same surgical procedure exemption. There are no safety issues that have been identified with the use of centrifugation by properly equipped labs or through closed systems. The FDA’s own statements in its early document entitled “Proposed Approach to Regulation of Cellular and Tissue-Based Products” are “[t]he agency would not assert any regulatory control over cells or tissues that are removed form a patient and transplanted back into that patient during a single surgical procedure. The communicable disease risks, as well as the safety and effectiveness risks, would generally be no different than those typically associated with surgery.” It’s unclear how the patient safety profile of centrifugation has changed since the late 1990s.

More Info::

Text of the FDA draft guidance Docket # FDA-2013-D-0446 Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability.

The FDA’s Q and A page on the draft guidance

A Regulatory Attorney’s Opinion of the Implications for physicians

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Preserve Access To Stem Cell Therapy In Europe

Click to endorse STEMSO letter.

Click to endorse the STEMSO letter.

Patients For Stem Cells asks our subscribers to endorse STEMSO’s letter to the European Medicine Agency. Help STEMSO protect access to cellular therapies for patients. To view the letter and endorse Click Here

The new EMA classification impacts ALL cellular therapies. It addresses “borderline” situations, essentially not allowing access to cellular therapies. Transplants are the exception to the new classifications, such as a liver transplant or a pancreas transplant. This new regulatory document effects all plastic surgeons, medical device companies, orthopedics, physicians, and all regenerative medicine prospective patients.

STEMSO has spent a great deal of time drafting a “collective” response and has placed the letter on our website . We are asking for “endorsements” of this letter to show the EMA CAT Committee that this letter represents the opinion of many.

The International Stem Cell Society, STEMSO, is a member based, international, non-profit 501(c) 6 trade association for the purpose of promoting the interests of the global, adult stem cell healthcare industry while linking patients and stakeholders with member medical organizations. STEMSO provides information, education, resources, advocacy and public awareness for the advancement of the adult stem cell industry.

Join the discussion! STEMSO on Facebook

For questions, contact:
Kathy Hebert, CEO/Co-Founder

4 part series published in Lamar University Press on evolving role of stem cell therapy in American medicine.

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Reported by Chelsea Henderson, named University Press editor at Lamar University in 2012, where her work has earned Excellence in Media awards. Chelsea has done a remarkable job of investigative reporting over the the past year on stem cell therapy. Interviews covered all stakeholders, including patients like PFSC members Claire Hooper and SammyJo Wilkinson, to explore the controversy that has arisen following the FDA’s determination that patients cannot utilize their own stem cells in the U.S., forcing them to resort to medical tourism abroad. Chelsea also tracked down regulators, doctors and scientific experts, to examine the scientific facts, and the restrictive regulations that no-option patients see as a death sentence.

The different types of stem cells are explained in clear language and illuminating graphics, starting with embryonic and man-made engineered induced pluripotent stem cells, which haven’t even entered human trials yet. Then autologous adult stem cells are examined, which have been in use for many years. The patient interviews she conducted reveal recoveries from conditions like multiples sclerosis and cerebral palsy, with positive results these patients had never been able to obtain with traditional medicine.

These reports represent the balanced reporting that Patients For Stem Cells has found to be lacking in much of the press stories on stem cells. This series stands as a comprehensive primer for anyone who needs to come up to speed on this important topic.

Stem cells spark controversy
October 23, 2013

FDA wary of ‘biological drugs’
October 30, 2013

Patients seek to reclaim stem cells
November 6, 2013

Handley leaves US for stem cells
November 13, 2013

Interview With The Author

PFSC How did this story come about, what caught your interest?

CH I began researching stem cells after my boss told me about his friend, an artist and Lamar University graduate, who was raising funds for stem cell treatment during the summer of 2012. She had multiple sclerosis, which I knew nothing about, so I wanted to educate myself about her disease, as well as how stem cells could be used as treatment. At this point in time, my research was only supposed to prepare me for that one article. But the more I discovered, the more gaps I found in the research and the less things made sense. I couldn’t understand how the scientific community could present the full potential of stem cells, there were patients all across the globe who were more than willing to use their own cells to heal their degenerating bodies, and somehow, the FDA had banned patients from doing so. That’s how my one story about an artist with MS turned into a two-piece story package and a four-part series.

PFSC What surprised you the most in your discovery research on stem cells?

PFSC When I began researching stem cells a year and a half ago, everything was new to me. I had no prior knowledge going in – I had never even heard of stem cells before. Once I became more educated, I was infuriated by how stem cells are regulated in the United States. The most surprising thing, however, was how the Food and Drug Administration handles inquiries about stem cells. Heidi Rebello, FDA Office of Media Affairs’ deputy director of operations, was the only FDA representative out of the 18 I contacted who agreed to answer my questions. Even then, all she did was paraphrase parts of the Code of Federal Regulations and send me a link to the full text. It was frustrating and complicated, and the only thing I could think during that lengthy process was, “Wow. If they’re making me jump through this many hoops just for some information, how are they treating sick patients who just want access to use their own cells?” This made me push even harder, and really helped turn writing this series into a civil rights issue.

PFSC Do you think you yourself will bank your stem cells, as insurance for future medical use?

CH I would love to bank my stem cells for future medical use. Without insurance coverage of such a procedure or any extra funds to speak of, however, this security is not an option for me at this time. If I ever needed to use my own stem cells, I would have to raise funds in order to travel abroad. I, like so many suffering Americans today, would be forced to engage in medical tourism just to access my own cells.

PFSC Knowing what you know now about the FDA regulations of our stem cells, do you agree or disagree with those regulations?

CH I absolutely disagree with how autologous stem cells are regulated. I understand why embryonic and induced pluripotent stem cells are regulated the way they are, and the FDA is 100 percent correct in doing so. However, I see no reason for the FDA to regulate autologous stem cells they way it does. The only danger I can see in using autologous stem cells is in mixing them with potentially harmful substances. But after interviewing stem cell patients, I am confident in saying that the ones that want to use their own stem cells – not embryonic or induced pluripotent – do not want a stem cell cocktail. They want to use their cells, and I see no reason for the FDA to interfere with that.

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