Table 2.
Procedures using adipose tissue and their regulatory status (homologous use, not regulated, or non-homologous use, regulated)
| Example procedurea | Regulatory use |
|---|---|
| Adipose tissue is used to fill voids in the face or hands (e.g., for cosmetic reasons). This is homologous use because providing cushioning and support is a basic function of adipose tissueb | homologous use |
| An HCT/P from adipose tissue is used to treat musculoskeletal conditions, such as arthritis or tendonitis by regenerating or promoting the regeneration of articular cartilage or tendon | non-homologous use |
| An HCT/P from adipose tissue is used to treat neurological disorders, such as multiple sclerosis, by limiting the autoimmune reaction and promoting remyelinization | non-homologous use |
| Adipose tissue is used for transplantation into the subcutaneous areas of breast for reconstruction or augmentation procedures | homologous use |
a
US FDA. 2017 “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-based Products.” Example 19-6.
b
The FDA defines the basic functions of adipose tissue as “providing cushioning and support for other tissues, including the skin and internal organs, storing energy in the form of lipids, and insulating the body.”