Email: info@BSBortho.com
Stem cell therapy has been around for decades, but in recent years, the use of stem cell therapy has increased. Stem cell therapy is used to repair or replace damaged tissue or cells within the body. Many in the medical community are hopeful that stem cell therapy can be used to treat a wide array of conditions.
Like other medical products, the Food and Drug Administration (FDA) oversees and regulates stem cell therapy treatments. In 2019, the FDA went to great lengths to warn consumers of the potential fraud that may arise from what it called stem cell therapy “hype.” A primary concern of the government is the marketing and use of unproven stem cell treatments as miracle cures, and at this time the FDA has not approved any stem cell-based products for use other than cord blood-derived blood-forming stem cells for certain blood diseases.
Many treatments are still only in early investigatory stages. Consequently, in 2017, the FDA issued guidance indicating its intent to “exercise enforcement discretion” as a means “to support and expedite the development of regenerative medicine products.” At Boston Sports & Biologics, we recognize the FDA’s important role in assuring patient safety. The FDA has issued compliance guidelines regarding the use of human cells, tissues, and cellular or tissue-based products. All of our treatment protocols are compliant with the published FDA guidance using minimal manipulation and homologous use. All of the commercial systems we use to process autologous cellular products for our platelet rich plasma (PRP), bone marrow concentrate and Lipogems procedures have received FDA-clearance to assure purity and potency. We do not culture cells and do not offer amniotic or birth tissue injections.
While we are in the earliest years of the development of the field of orthobiologics, the evidence is mounting at an accelerated rate. At Boston Sports & Biologics, we attempt to stay current with the published literature, and are involved with publishing book chapters, research articles and being involved with national organizations including the Interventional Orthopedic Foundation.
We attempt to use the peer-reviewed published medical literature when available, and our practice is focused on managing minor orthopedic conditions at a relatively low cost for patients.
No. The FDA regulates stem cell therapies as "biologics." Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the “hematopoietic” system) but they are not approved for other uses.
No. Exosome products are regulated by FDA. As a general matter, exosome products intended to treat diseases or conditions in humans require FDA approval. There are currently no FDA-approved exosome products.
No. Stromal vascular fraction has not been approved by the FDA for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain. Since the removed tissue (fat) and reimplanted material (SVF) is considered substantially different the FDA has ruled that SVF is more than "minimally manipulated."
No. Clinics currently offering these products outside of FDA’s review process and flouting federal statutes and FDA regulations. They are considered to be drugs under section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and biologics under section 351 of the Public Health Service Act (PHS Act). No human umbilical cord blood, Wharton’s Jelly, or Amniotic fluid products have completed the necessary applications to lawfully market a drug as a biological product, and fail to meet the "homologous use" criteria that would allow these drugs to be categorized as less restrictive human cell, tissue, or cellular or tissue-based products.