I got this email today.
Dear Colleagues,
I have been getting many inquiries regarding the current regulatory status of stromal vascular fraction (SVF) used in clinic. In fact, I have even heard rumors that we were shut down by the FDA and prevented from doing SVF. This is simply untrue and there have been no changes in the regulatory status of medical procedures done in clinic including SVF.
The FDA has recently released a draft guidance document regarding the use of human cell and tissue products used during the same surgical procedure from adipose tissue and has requested comments from the public on this guidance. Please note that guidance documents represent the FDA's "current thinking on the scope" of the topic. "FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA's guidances means that something is suggested or recommended, but not required."
We do not believe that the current draft guidance document will affect our ability to offer in-clinic cell therapy from fat to our patients. The FDA's document has elicited much resistance from the public. Additionally, highly respected organizations such as AABB Center for Cellular Therapies and The Academy of Regenerative Medicine have voiced their opposition. Even if the document were published as is, we do not believe it gives the FDA legal authority to stop these procedures.
It is impossible to predict what the FDA will do regarding any in clinic therapies so I can only tell you what has happened in the past. In December of 2014, the FDA visited our lab as well as three physicians who are doing SVF procedures. The FDA took no action against anyone and did not stop the SVF procedures. Many of you have seen that these procedures can provide benefit to patients who have failed other therapies. Our primary goal has been and will continue to be safety and well-being for our patients.
Feel free to contact me if you have any questions or would like to discuss this further.
Regards,
Kristin Comella
Chief Scientific Officer
BIOHEART INC.
