Bill > HB2246

This bill establishes requirements for stem cell therapies in Tennessee, defining "human cells, tissues, or cellular or tissue-based products" and "minimally manipulated" to clarify what is covered. It allows physicians to perform stem cell therapy not approved by the U.S. Food and Drug Administration (FDA) for specific treatments like orthopedics, wound care, or pain management, provided the stem cells are retrieved, manufactured, and stored in FDA-registered facilities that are also certified or accredited by recognized organizations such as the National Marrow Donor Program or the American Association of Tissue Banks, and that the cells are viable upon post-thaw analysis. Physicians must ensure their facilities adhere to federal "current good manufacturing practices" and must obtain specific information from stem cell suppliers regarding their certification status, with facilities required to notify physicians of any changes. Furthermore, any advertisement for these unapproved stem cell therapies must include a clear notice informing patients that the therapy is not FDA-approved and encouraging consultation with a primary care provider, and physicians must obtain a signed consent form from patients detailing the treatment's nature, risks, benefits, and alternatives. The bill exempts physicians using FDA-approved investigational drugs or working for accredited institutions, and prohibits the use of stem cells derived from fetuses or embryos after an abortion, with violations potentially leading to disciplinary action or criminal charges.

Health and Social Services

https://wapp.capitol.tn.gov/apps/Billinfo/Default?BillNumber=HB2246&ga=114