āNever Frozenā...What That Actually Means (And What It Doesnāt)
To make sense of it, you have to start with how these procedures are actually regulated in the United States. Most of what people casually refer to as āstem cell therapyā falls into one of two broad categories. On one side, you have the Section 361 frameworkā¦procedures that are considered minimally manipulated, used in a homologous way, and often performed within the same surgical setting. On the other, you have Section 351, which is the full biologics pathwayā¦the same regulatory category as drugs, with all the complexity, cost, and oversight that implies. The phrase ānever frozenā almost always lives on the 361 side. In practical terms, that means a physician can take your tissueā¦bone marrow, blood, etcā¦place it into a centrifuge, spin it for about 15 to 20 minutes, and reinject it back into your body during the same procedure. But hereās where things start to diverge from what patients think is happening. āMinimal manipulationā is a regulatory classification. It is not a quality standard. Cash-pay clinics operating under this model are not performing cell quantification assays. Theyāre not running sterility tests. Theyāre not validating potency. And theyāre not operating under GMP manufacturing conditions. If they did any of those processes, they would be āmore than minimal manipulatingā the tissue. So they canāt, by Law! Or they would have to reclassify the entire procedure under Section 351ā¦and they really dont want to do that This is where the ānever frozenā marketing slogan comes in If you look at a typical BMAC procedureā¦extract, spin, injectā¦the actual number of mesenchymal stem cells in that sample is extremely small. Weāre talking about something on the order of one stem cell for every 100,000 of the other kind of cells in the original tissue. Even after centrifugation, you might end up with roughly 100k stem cells in total, sometimes less depending on the doctorās technique. Thatās not a lot. Now imagine taking that already small population and putting it through a freezeāthaw cycle. Losing 20% of the cells during thawing is not unusual.