Orthobiologic Therapy

Orthobiologics are biological substances derived from blood, bone marrow, fat and placental substances produced in your (autologous) or someone else’s body used in orthopedic medicine to help musculoskeletal injuries heal faster and stronger. They are used to improve the healing of bones, injured muscles, tendons, ligaments, and fascia. Although there have been thousands of articles published about the successful treatments of patients, the FDA has not approved the use of them except in very limited circumstances. They have decided that the use of all of these substances (except PRP) is experimental and not recognized as safe or effective. Thus, practitioners are not allowed to promote the idea that using these products is proper, safe, or legal.

You will need to speak with Dr. Kochan to know what is the best course of action to take in your specific circumstance.

Certain processes for extraction of platelets from blood have been approved by the FDA and have experimental clinical evidence of efficacy. See the section for PRP.

Placental Products

The FDA has mandated that all products which are derived from a placenta (including amniotic tissue, cord blood, and Morton’s Jelly) have to be tested for diseases and have to be irradiated. Thus, any living tissue in placental products is no longer viable after irradiation. You cannot legally buy or use any tissue in the USA that has “live stem cells in it” unless it is from your own body. There are no living stem cells in placental products. There are many powerful growth factors in placental products which may or may not be useful for healing. There is very little research at this time to support their use which is why the FDA has declared their use to be illegal in orthopedic procedures. However, some of these products are legal to use for dermatologic procedures and in wound healing.

Bone Marrow Autologous Cells (BMAC)

The only FDA approved treatments for stem cells DERIVED from bone marrow is for treating certain blood or bone marrow disorders or following radiation treatment. BMAC contains many different cells including medicinal signaling cells, progenitor cells, and platelets all of which can facilitate healing. Under some circumstances autologous bone marrow BMAC can be injected into the femur and humerus and some other larger bones in an attempt to repair their structure and function. This can be discussed with Dr. Kochan to determine if these injections might help you.

Adipose Derived Stem Cells

The use of Adipose (fat) derived stem cells is not FDA approved, except if these cells are injected back into tissue, which normally has fat in it such as breasts and faces. Since fat does not normally exist within joints according to the FDA, it cannot legally be injected into joints.

Exosomes

Exosomes are messenger molecules produced and excreted by stem cells which have been exposed to various conditions. Normally the stem cells monitor the conditions in their environment and when they notice something wrong, they excrete exosomes in an attempt to correct the situation. These compounds thus direct the healing of the tissue. This new technology is not approved by the FDA for orthopedic use in humans, but again may be used in dermatologic applications.