Tuesday, March 14, 2017

Ethical Guidelines for Orthobiologics

Neokine (www.neokine.com) is siding with science-based medicine. An Ethical approach is missing in many practices, claiming the correct use of biologics. We like and support the principles laid out by Dr Centeno of Regenexx stated below.
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. These include stem cells and other cells such as macrophages, leukocytes, pericytes, RBCs, etc, cytokines, platelet rich or poor plasma, serum, extracellular matrix, fat grafts, and other tissues.
  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 web-site, 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 that are commonly trained to see neuromusculoskeletal injury such as PMR, Orthopedics, Interventional Pain, Family Practice with a Sports Fellowship, or other disciplines where significant MSK training has been pursued 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 guidance documents.
  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.

Written by

Chris Centeno, M.D.
 Chris Centeno, M.D.
CEO at Regenexx

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