Many clinics are using Amniogenic based materials for musculoskeletal conditions. These are not “miracle products” nor are they “stem cells”. The FDA has approved the placenta amnion allograft (another person’s tissue) for use as a sheet/membrane only (in its natural form) for tissue grafting of soft tissue defects. This would include tendons and other soft tissue injuries such as traumatic skin wounds. The FDA has explicitly stated that products which are more than “minimally manipulated” cannot be used in the United States as a tissue. These would have to be classified as a drug and be proven to be “safe and effective” before they could be used in humans. This includes any “injectable” material from amniogenic tissue, as it would have to be more than “minimally manipulated” to be used in injectable form. The approval as a drug is expensive and time consuming, leading many biologic companies to circumvent the process by getting approval as a tissue and then marketing to physicians, the products use in an unapproved manner.
Current science suggests there are healing properties of the cells and biochemicals (growth factors, etc) of the amnion and these tissues are immuno-privileged (i.e. they do not create an immune rejection response). However, they do not come in a natural form that is FDA approved for use in joints to help regenerate degenerative joint surfaces or slow the arthritic process. The latter has been a common advertised use and application, especially by pain clinics and non-orthopedic medical professionals. Any use outside of tissue grafting with an amnion membrane is considered to be OFF LABEL and must be explained and consented for in writing. No long term studies have been done in humans to determine if the injection of these substances are “safe and effective”. In fact, it is unknown if they can destroy joints or lead to tumor growth. In addition, no study has yet demonstrated a definitive positive response in the the healing of any tendon/ligament/muscle injury, although there are many ongoing projects examining the effects of these substances.
Dr. Bailie has used these therapies sparingly in some high level athletes with very good SUBJECTIVE outcomes, with improved pain and function. These have specifically been requested by patients. The science is explained and the injections not provided until a patient has had a chance to do their own research (CLICK HERE FOR MORE). However, there is no data to suggest the regeneration of normal tissue or more rapid healing of injuries at this time. Given the cost (several hundred to several thousand dollars per injection), it is not recommended for widespread use. If you would like more information, please make an appointment with Dr. Bailie and he can determine if it is something you should even consider.
Dr. Bailie has had extensive experience with AMNIOGENIC products. While some clinics proclaim that they are “stem cells” and have “cured” people with a variety of joint problems, those facts simply are not true. Dr. Bailie continues his clinical investigations of these new biologics and encourages patients to read about them prior to consenting to use. Although data suggests no side effects, infections or reactions, data is simply lacking to determine the long term effectiveness of these products. In addition, there are many manufacturers on AMNIOGENIC products who market their “grafts” to physicians. While the marketing literature seems truthful on its face, it can be misleading. Dr. Bailie has scrutinized these in great detail, and the associated scientific literature, in order to provide this new technology to his patients using the best and safest product. He currently uses MiiMedx AMNIOFIX. For detailed information regarding this product, click the yellow AMNIOFIX link below.
Cell Therapy for Osteoarthritis
JBJS Editorial Stem Cells
Stem Cells in Orthopedics – A Comprehensive Guide for the General Orthopedist – The American Journal