With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products.
There are more than 100 such American clinics that are selling stem cell “treatments” to patients and almost all of them use non-FDA approved stem cell products isolated from fat tissue.
The clinics have argued that they do not need FDA approval and just keep on raking in big profits from vulnerable patients.
They have claimed no need for FDA approval because they believe that the stem cells isolated from fat tissue that they use are not “drugs” because they are “not more than minimally manipulated.” In English that means that the clinics are arguing that the purified fat stem cells are basically the same as overall fat tissue.
To me that doesn’t make any sense.
A groundbreaking draft guidance statement today by the FDA for the first time sends the message to the clinics that the clinics are very likely wrong and could be subject to future regulatory action.
It is important to point out that this FDA statement that mentions fat stem cells is “draft guidance” meaning that it is not yet finalized, but make no mistake that this is the clearest snapshot to date on the FDA’s views on fat stem cells and it is unlikely to fundamentally change during the comment period.
The bottom line is that fat stem cells are viewed by the FDA as drugs that must be vetted and approved prior to use by physicians and clinics. It also reinforces statements from draft guidance issued earlier in October that narrowed exceptions to the same-day surgical procedure guidance for use of biological materials such as stem cells.
In the new document today, the FDA even sets out isolation of fat stem cells as an example of more than minimal manipulation (emphasis mine):
Example 10-1: Original relevant characteristics of adipose tissue, a structural tissue, to pad and cushion against shocks generally include its bulk and lipid storage capacity. A manufacturer recovers adipose tissue by tumescent liposuction and processes the adipose tissue to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells. The HCT/P generally is considered more than minimally manipulated because the processing breaks down and eliminates the structural components that provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement.
A tissue product that is “more than minimally manipulated” again is a biological drug requiring prior FDA approval before use in patients.
I agree with this new FDA draft guidance because again fat stem cells are to my mind (as a cell biologist who has been studying cells for more than two decades) different than fat tissue. Fat stem cells constitute a biological drug that should be approved by the FDA in advance as well as tested in clinical trials before experimental, for-profit use on patients.
Another issue that applies is “homologous use” meaning that a product such as fat stem cells can only be used in a similar fashion or it is automatically a drug. For example, fat stem cells in theory could only be used therapeutically in a manner related to fat tissue-related health problems. The clinics today use fat stem cells to treat pretty much every condition from head-to-toe, which is clearly non-homologous use.
You can make a comment to the FDA on this draft guidance by following the instructions below pasted from the FDA guidance page.
How to make a positive difference? I encourage you to make a quick comment supporting the definition of fat stem cells as more than minimally manipulated and hence biological drugs. It is the safest thing for patients and the best way to go for the stem cell and regenerative medicine field.
Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.