The United States Food and Drug Administration (FDA) has regulatory authority over regenerative medical products, including regenerative cells. There is much misleading information on the internet, including conditions that regenerative cells can be used to treat. The FDA has concerns that many patients seeking cures and remedies may be misled by information that is illegally marketed. This may be harmful, and often costly without proven effect. As of July 22, 2020, the FDA has updated its stance on using regenerative cells for orthopedic problems, such as arthritis, tendinitis and other injuries. Their recent delay in developing this policy has led to the propagation of over 18,000 “regenerative cell clinics” in the United States alone.
Regenerative cells are found in three places: Amniotic, fat (adipose), and bone marrow.
Amniotic sources:
Regenerative cells that are derived from amniotic sources, i.e., umbilical cord of a c-sectioned child delivery, are currently only approved for blood disorders, but not for other uses.
Fat derived (adipose regenerative cells): Though there are many regenerative cells in fat:
- None of these have been FDA approved for prevention of COVID-19 or adult respiratory distress (ARDS).
- None have been approved for treatment of orthopedic conditions such as osteoarthritis, disc disease, or hip and knee pain.
- None are approved for neurologic disorders such as MS, ALS, Parkinson’s, Alzheimer’s, epilepsy and stroke.
- None are approved for cardiovascular, pulmonary, eye or autism problems. The one exception is Amnio Fix for knee arthritis which may be approved for use the FDA, however, these are not live regenerative cells as they have been processed in a factory.
Bone marrow:
What is allowed? Use of regenerative cells from bone marrow and platelet rich plasma for orthopedic conditions are exempt from the FDA scrutiny if they are:
- Autologous (from the same patient)
- Minimally manipulated
- Removed from bone marrow, not fat, and spun in an FDA approved centrifuge; then placed back into the patient with the same procedure without propagating or storing these cells over night or for future procedures.
Many “regenerative cell” clinics violate these rules.
Procedures at Orthopedic Associates of SW Ohio are compliant with current FDA regulations:
- These include Platelet Rich Plasma (PRP) Injections taken from a simple blood draw from your arm.
- Office-based bone marrow concentrations from one’s own pelvis can be spun in an FDA proven centrifuge device and then placed accurately in the area of concern using ultrasound guidance.
- Some of these procedures are performed with surgical procedures at the hospital when this is decided upon in advance.
There are considerable studies showing the safety of the above procedures in orthopedic literature, and aside from local discomfort at the site of the bone marrow aspiration, most of these procedures are performed in an office setting within an hour. A friend or family member should drive the patient home the same day. Finally, our physicians have specialized training in regenerative medicine and are guided by the FDA approved guidelines, safety and compliance regulations.
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