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MSCs are multipotent cells (also called stromal multipotent cells) that possess the ability to differentiate into various tissues including organs, trabecular bone, tendon, articular cartilage, ligaments, muscle and fat. MSCs are associated with the blood vessels within bone marrow, synovium, fat and muscle, where they can be mobilized for endogenous repair as occurs with healing of bone fractures. Stimulation of endogenous MSCs is the basis of procedures such as bone marrow stimulation (e.g., microfracture) and harvesting/grafting of autologous bone for fusion. Bone marrow aspirate is considered to be the most accessible source and thus the most common place to isolate MSCs for treatment of musculoskeletal disease. However, harvesting MSCs from bone marrow requires an additional procedure that may result in donor site morbidity. In addition, the number of MSCs in bone marrow is low, and the number and differentiation capacity of bone marrow derived MSCs decreases with age, limiting their efficiency when isolated from older patients.

Tissues such as muscle, cartilage, tendon, ligaments, and vertebral discs show limited capacity for endogenous repair. Therefore, tissue engineering techniques are being developed to improve the efficiency of repair or regeneration of damaged musculoskeletal tissues. Tissue engineering focuses on the integration of biomaterials with MSCs and/or bioactive molecules such as growth factors. In vivo, the fate of stem cells is regulated by signals in the local 3-dimensional microenvironment from the extracellular matrix and neighboring cells. It is believed that the success of tissue engineering with MSCs will also require an appropriate 3-dimensional scaffold or matrix, culture conditions for tissue specific induction, and implantation techniques that provide appropriate biomechanical forces and mechanical stimulation. The ability to induce cell division and differentiation without adverse effects, such as the formation of neoplasms, remains a significant concern. Given that each tissue type requires different culture conditions, induction factors (signaling proteins, cytokines, growth factors, etc.) and implantation techniques, each preparation must be individually examined.

The U.S. Food and Drug Administration (FDA) has stated that “cell-based therapies are one of the most rapidly advancing approaches intended to repair, replace, restore, or regenerate cells, tissues and organs. They can be applied to damage caused by disease, injury, or aging. Many cell-based therapies use immature cells (stem cells) that are expanded outside of the body. The expanded cells are sometimes used in their immature state, but they are often manufactured into more mature cells before they are given to a patient. The resulting cells are intended to repair cell or tissue damage (efficacy) without unintended serious consequences such as tumors, severe immune reactions, or unwanted tissue development (safety). Manufacturing of large numbers of cells outside the natural environment of the human body may lead to ineffective or dangerous cells, so it is important to understand and carefully control the production process and to define measures that reliably predict safety and efficacy of the cell-based products.”

No products using engineered MSCs have been approved by the FDA for orthopedic applications.

The FDA has determined that the mesenchymal stem cells sold by Regenerative Sciences for use in the Regenexx™ procedure would be considered drugs or biological products and thus require submission of a New Drug Application (NDA) or Biologics Licensing Application (BLA) to the FDA.  To date no NDA or BLA has been approved by the FDA for this product.

Related medical policies include Recombinant and Autologous Platelet-Derived Growth Factors as a Primary Treatment of Wound Healing and Other Miscellaneous Conditions and Autologous Chondrocyte Implantation and Other Cell-based Treatments of Focal Articular Cartilage Lesions.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

06/22/2011: Policy reviewed; no changes.

05/09/2012: Policy reviewed; no changes.

Non-Covered Codes

This is not an all-inclusive list of non-covered procedure codes.

All codes billed for this procedure are considered investigational and not eligible for coverage. 

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