StemCell Therapy

With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US.

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 inbig 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 doesnt make any sense.

A groundbreaking draft guidance statement today by the FDA for the first time sends the messagetothe clinics that the clinics are very likely wrong and could be subject to future regulatory action.

Itis important to point out that this FDA statement that mentions fat stem cells isdraft guidance meaning that it is not yet finalized, but make no mistake that this is the clearest snapshot to date on the FDAs 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 fromdraft 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.

Go here to see the original:
Breaking: New FDA Draft Guidance Views Fat Stem Cells As ...

This entry was posted on May 22, 2015 at 4:46 pm and is filed under Fat Stem Cells. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |