The world of Regenerative Medicine is racing ahead. Recent innovations in the processing of adipose tissue (fat) have created a new crop of innovators seeking to leverage and commercialize the use of adipose tissue and adipose derived regenerative cells for a host of applications. Many of these
innovations are focused on the cosmetic and plastic surgery industries. Companies are marketing cellular preparation kits, fat transfer methods and supplies, as well as services to process tissues and return them to the physician the same day.
With all this activity and the myriad new companies marketing to you, how do you decide what is best for you and your patient? How do you protect your patients while providing them with cutting edge cellular therapies and treatments? How do you assess the efficacy of these treatments? How do you know that you are compliant with current regulations (industry guidance)? Which regulations apply and which do not?
These questions loom large within the industry and its regulators. This is especially true for new products and processes that claim exemption from the regulations. The answers are not always
obvious or easy.
We have spent years reviewing and interpreting the current regulations with scientists, lawyers and doctors. While there are many factors that impact decision making, we believe that before acting, some basic questions should be asked and answered.
- How is this product or process regulated on the state and federal levels?
- Is there any regulatory guidance that can be reviewed?
- Am I required to have my treatment protocol reviewed by an Institutional Review Board?
- If the product or process is to be used immediately, how can sterility be assured?
- What tests for sterility need to be performed? How and when are the results delivered?
- What is the yield of viable regenerative cells? How are they described?
- What is the actual makeup of the resulting product: i.e. how many fibroblasts, stem cells, adipocytes, osteoblasts, chondrocytes, etc?
- Is the sample free of other contaminants and/or damaged cells?
- What data can be provided to support your position and claims?
- How can the efficacy of the treatment be monitored and assessed?
These questions should be answered by a company that is seeking to provide you with products or services for cellular therapies. They should be able to provide you with guidance and answers that help you be confident and comfortable presenting and explaining the product or service to your patients provide you with information so you fully understand the implications of your use of the product or service ensure that you have taken every precaution and instituted correct policies and procedures ensure the safety of your patient with the use of their product or service keep you and your practice operating within the very complicated web of regulation.