Law and Order: SVF

elephant in the roomA big, fat elephant in “the room” of the commercial stem cell field today is something called stromal vascular fraction or SVF, made from human fat tissue or adipose.

If you care at all about stem cells or the stem cell field more generally, you had better educate yourself on SVF.

You can learn a lot more here and in my new book, Stem Cells: An Insider’s Guide where I extensively discuss SVF, talk about the protocol to make it, and include the nifty diagram below, which please note is not intended as an actual guide of how to make this product.

SVFSVF is a complex tissue and cellular product made from fat. It is a diverse product that likely contains at least a dozen types of cells including stem cells and a whole soup of associated growth factors and cytokines. It has real potential as a biological drug, but the clinical use of SVF is moving too fast, far faster than the data backing it up so far.

SVF is arguably one of the hottest and fastest growing stem cell-related products, but also the most misunderstood. It is the basis of hundreds if not thousands of patient “stem cell” interventions sold in the US alone per year.

Many physicians seem to misunderstand or misinterpret how SVF is regulated and as a result may be putting their patients and their practices as risk. The regulatory status of SVF makes it a very high risk proposition to use clinically. On the one hand, to my knowledge, every indication made in public by the FDA has been that SVF is a biological drug subject to regulation and licensing at the 351 level no matter how you make it. I’ve never seen any public guidance to the contrary.

On the other hand, literally dozens of clinics in the US alone are sell stem cell interventions to patients based on SVF without FDA approval or potentially important associated tasks such as getting an IND, potentially a BLA, etc.

The consensus amongst experts, consistent with my own conversations with the FDA, seems to be that SVF is a biological drug pretty much no matter how you produce it (with collagenase, sonication, or some other way), but to my knowledge the FDA has taken relatively few actions regarding SVF despite its common for-profit use.

Many in the field are asking why the FDA has taken action in certain SVF-related cases, but not in others that seem of equal or arguably far greater apparent risk to patients.

Are more actions coming soon related to the exploding essentially unregulated clinical use of SVF in 2014? I guess we’ll find out.

If not, unfortunately the FDA may continue to send mixed messages that put patients, physicians, and the stem cell field at greater risk. The legitimate physicians and researchers appropriately studying the clinical potential of SVF are also being put at risk by the regulatory ambiguity and the non-compliant clinics too.

3 thoughts on “Law and Order: SVF

  1. Pingback: Knoepfler Lab Stem Cell Blog – Law and Order: SVF | Stu's Stem Cell Blog


  2. Paul – You stated, “Many in the field are asking why the FDA has taken action in certain SVF-related cases, but not in others that seem of equal or arguably far greater apparent risk to patients.”
    You keep mentioning risk and yet thousands of patients are being treated. Where is the evidence that patients are at risk or are dissatisfied with their treatments? In my patient sphere, we are asking why is the FDA interfering in the practice of medicine, not why are they not taking action. Patients know that the far greater risk to them is to do nothing while their disease progresses to the point they are totally incapacitated.
    You almost sound disappointed that the FDA isn’t taking action. I guess the agency doesn’t see these clinics as the threat that you do. That’s a refreshing change.

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