Science of Stem Cells
Stromal Vascular Fraction (SVF)
What is stromal vascular fraction?
>> DR. MARC PENN: Stromal vascular fraction, or SVF, is a mixture of stem cells that exists in our adipose or fat tissue. It contains mesenchymal stem cells and endothelial progenitor cells as well as some endothelial cells. This mixture is a rich mixture of stem cells that ultimately has a higher percentage of mesenchymal stem cells, kind of the conductor of the repair process, than our bone marrow does. And, as we age, we don’t lose mesenchymal stem cell number or mesenchymal stem cell function from our fat as we do from our bone marrow.
What are the benefits of enzyme-derived SVF?
>> DR. MARC PENN: As a physician and scientist, I think enzyme-derived SVF is superior because by using the enzymes we release the stem cells from the tissue, from the fat. We disperse them into solution, and that solution can be used not only to inject the joint or the organ that’s been injured, but also given intravenously to activate the endogenous stem cell system, and by activating the endogenous system, as well as treating the organ or tissue that’s been injured, data suggests we’re better off and more likely to get a meaningful tissue repair than using either alone.
Is SVF approved by the FDA and why not?
>> DR. PENN: The regulatory status of SVF is complex. Its initial use was to take fat from one part of the body and move it to another part of the body by plastic surgeons for breast reconstruction, facial reconstruction, things of that nature. That goes on every day today, and there are no regulatory issues for that. It is functionally unregulated.
When we then start talking about isolating cells from the fat to make SVF, or stromal vascular fraction, now we get into a complex regulatory situation.
If it’s done through mechanical means by either sucking the cells in and out of a syringe, something to break down the matrix mechanically, it fits what’s called the minimal manipulation statute of the FDA and is not regulated. It’s not approved, but it is not regulated currently. In a matter of time, the FDA will, in fact, start to regulate mechanically isolated SVF.
Then there’s enzyme-derived SVF, where we use an enzyme to digest the tissue so that now the stem cells are free of their matrix, their most active state, and they’re dispersed such that we can give it intravenously safely.
That enzyme that’s used is regulated by the FDA. It is currently under multiple clinical studies, including those by Tissue Genesis, and has to be approved before it can ever be sold in the United States.