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It is important to understand that stem cell therapies are considered experimental, and that although individual results are promising for certain patients, the FDA has not approved these treatments at this time. Further high-quality research studies are still needed to learn about their efficacy.

Regenerative medicine and stem therapies hold potential for significant improvement in pain and function for a select group of patients and conditions. Full workup including imaging studies, detailed medical history, and physical exam, and history of past treatments are needed to determine if regenerative medicine should be considered as a treatment option.

Stem cell therapy is an area of regenerative medicine that has gained much interest in the last few years. Touted by some providers as the “holy grail” to treat many musculoskeletal conditions such as bursitis, tendonitis, ACL tears, rotator cuff tears, arthritis, and other diseases, it has become an area of great controversy because of the lack of adequate studies and the cash fees charged by some for unproven and unapproved uses. This section will provide you with transparent, TRUTHFUL information on stem cells and other cell therapies.

Many providers advertise that they are now harvesting “stem cells” and injecting them into the various site to “cure” degenerative disease. In fact, stem cells can be made from bone marrow, adipose (fat) cells, and other tissues. However, it is not LEGAL to process these tissues in order to obtain pure, viable stem cells. In fact, what is being injected is simply centrifuged cells and other factors in uncontrolled concentrations. This cell population may contain some true pluri-potential cells but is not of sufficient concentration to constitute a “stem cell” therapy. Processing the cells to actually create a viable stem cell line requires using unapproved methods to multiply the cells and process them, and remove cells that are potentially harmful. This is not legal nor FDA approved in the United States and thus is NOT available except in other countries.

As cited from Richard K. Burt, MD et al, JAMA. 2008;299(8):925-936. doi:10.1001/jama.299.8.925.
Stem cells harvested from blood or marrow, whether administered as purified HSCs or mesenchymal stem cells or as an unmanipulated or unpurified product can, under appropriate conditions in select patients, provide disease-ameliorating effects in some autoimmune diseases and cardiovascular disorders. Clinical trials are needed to determine the most appropriate cell type, dose, method, timing of delivery, and adverse effects of adult HSCs for these and other nonmalignant disorders.

FDA REGULATORY POSITION

Human cells, tissues, and cellular and tissue-based products

The governing statute is Public Health Safety Act, Section 361.

  • The major objectives of this statute are to prevent the use of contaminated tissue, limit the improper handling of tissues,
    and ensure the clinical safety and efficacy of cells or tissues that “are highly processed, are used for other than their
    normal function, are combined with non-tissue components, or are used for metabolic purposes.”
  • Different standards apply, depending on the seriousness of a disease and an assessment of the potential risks and benefits
    of the treatment.13 These standards are consistent with the regulations governing accelerated approval of therapies
    for serious or life-threatening illnesses.
  • This statute is supplemented by FDA guidance documents, which will need to be expanded or revised to address specific
    issues regarding stem-cell–based therapies and to clarify the definitions of “highly processed” and “used for other
    than their normal function.”

BIOLOGIC PRODUCTS

The governing statute is Public Health Safety Act, Section 351.

  • Any stem-cell–based product that includes cells or tissues that “are highly processed, used for other than their normal function, are combined with nontissue components, or are used for metabolic purposes” will be regulated as a
    biologic product.
  • As currently envisioned, most, if not all, stem-cell–based therapies will be considered to be biologic products.
  • The manufacturer of a biologic product must demonstrate that it is “safe, pure, and potent.”
  • To investigate the use of a stem-cell–based product that is a biologic product in humans, an investigational new drug
    application that reports data from preclinical studies on the likely safety and efficacy of the investigational product
    must be filed with the FDA.
  • To license a biologic product, an application for a biologic license must be approved by the FDA. Such approval requires
    sufficient data demonstrating that the investigational product is safe and effective in humans.

Although regenerative medicine therapy is promising it is NOT FDA approved for use at this time.

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