First Draft of Guidelines for the Ethical Practice of Orthobiologics

As I’ve blogged about many times before, we’re in the wild west of stem cells. I see stuff being advertised every day that makes no scientific sense, and, regrettably, most physicians working in this area don’t know what they don’t know. The physicians and companies who do take this field seriously have discussed in various forums the need for an ethical guidelines statement. The goal is to craft this document so that the ethical providers and device manufacturers can all sign on and then adhere to these principles. This is my first draft of that document:

Background: As providers who use orthobiologics to treat our patients, we have observed unethical behavior and advertising that isn’t consistent with best physician practices. Hence, we wish to provide a set of ethical guidelines for orthobiologic use to which we can all strive to adhere. For the purpose of this document, orthobiologics are defined as substances that can facilitate the healing of bone, tendon, ligament, muscle, cartilage, or nerve.

  1. If outcomes and risks are discussed, you should have, at least, case-series outcome data on the specific procedure you are performing. If that’s not available, then you should discuss outcomes solely based on your experience.
  2. If research is posted to your website, it needs to be research that represents the procedure you are using. For example, if the provider is using stromal vascular fraction from adipose tissue, posting research that used culture-expanded mesenchymal stem cells is inappropriate.
  3. You should practice within your specialty area. For example, providers who are commonly trained to see neuromusculoskeletal injury, such as PMR, orthopedics, interventional pain, and family practice with a sports fellowship, should only treat patients with neuromusculoskeletal injuries. As an example, an orthopedic surgeon or PMR specialist treating patients with multiple sclerosis with an IV infusion of stem cells is inappropriate.
  4. Claims made about the cellular or cytokine content of a product or procedure should be substantiated using reasonable science. For example, a physician should not rely on the testing from a manufacturer that purports to have an amniotic or cord “stem cell” product unless the data supplied can substantiate the claim. If the claim can’t be substantiated, then the act of that provider advertising to the public that he or she is performing a stem cell procedure constitutes consumer fraud.
  5. The use of orthobiologics is a physician-level procedure. The goal for regenerative medicine is the improvement of existing surgical or interventional subspecialties or the creation of new ones that require physician-level thinking, knowledge, and experience. Hence, it is not appropriate for a mid-level provider to be practicing regenerative medicine of the neuromusculoskeletal system using orthobiologics.
  6. Your use of orthobiologics must comply with all applicable state and federal laws, regulations, and guidances.
  7. Whenever possible, the use of investigational procedures, substances, or devices should be the subject of research or data collection, and that information should be made available in a public forum.

The upshot? This is a first draft that I’m sure will be edited, but it’s a start at trying to clean up an out-of-control field. It’s my hope that disparate interests who are trying hard to do good work using PRP, cytokines, and stem cell procedures can come together and drive out the nutty stuff and practitioners.

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  1. With all that I have read about Reginexx I want to know if treatment advised by Reginexx would help me or not. I had knee surgery done which has not been successful.I still have pain and disability , particularly around the head and neck of fibula and under patella , which I was told after the surgery that fibula and patella are not a part of knee surgery and now do not want revision surgery.Will Reginexx treatment help me?

    1. Dr. Mauskar,
      With a knee replacement, there is no biological knee joint to treat, so the patella sits over metal and plastic. While the fibula was not part of the surgery, damage to the area is possible. But we won’t know if there is anything we can do to help without reading the MRI. If you’d like us to take a look, please submit the Candidate form so you can upload your MRI: http://www.regenexx.com/the-regenexx-procedures/knee-surgery-alternative/

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