A few weeks ago, the FDA issued new guidance for the use of products for cellular therapy that has significant implications for surgeons and physicians performing autologous stem cell therapy. The guidelines specifically define important points such as the handling of the material after donation and before implantation in the patient.
The guidelines are contained in Section 1271.15b of CFR21, titled “Human Cells, Tissues, and Cellular and Tissue-Based Products,” (from her onwards referred to as Cell Product) while the new regulations are entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.”
In essence, the FDA outlines that procedures will be exempt from regulations requiring FDA application if they fall within the scope of the “same surgical procedure.” Examples given by the FDA as falling within the exception include:
1) Autologous use, in which the Cell Product is removed and implanted back to the same individual
2) The Cell Product is implanted back to the “same individual within the same surgical procedure”
3) The Cell Product has been “minimally manipulated”
4) The risk of disease transmission is no different from surgical procedures
Two important considerations have appeared in industry debates that have followed as a result of the FDA’s new draft guidelines: the first is the definition of “same surgical procedure.” While the FDA states that “rinsing or washing the Cell Product” prior to transplantation still constitutes the “same surgical procedure”, little mentioned of more involved processes such as physical methods of cell separation.
Secondly, however, the FDA also states that “Whole blood or blood components or blood derivative products” and “minimally manipulated bone marrow” do not constitute Cell Products as might not, as such, have to follow the Guidance or exceptions pertaining to it.
All in all, the Guidelines are considered a positive step forward for the FDA in their effort to improve the current regulatory landscape surrounding cell therapy which is much need of such guidelines. And while the guidelines are merely a draft, opening the conversation can only be a positive step.